--- title: A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 nct_id: NCT00712933 overall_status: COMPLETED phase: PHASE3 sponsor: Human Genome Sciences Inc., a GSK Company study_type: INTERVENTIONAL primary_condition: Systemic Lupus Erythematosus countries: Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, India, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00712933.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00712933" ct_last_update_post_date: 2019-12-05 last_seen_at: "2026-05-12T06:42:40.528Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 **Official Title:** A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 **NCT ID:** [NCT00712933](https://clinicaltrials.gov/study/NCT00712933) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 738 - **Lead Sponsor:** Human Genome Sciences Inc., a GSK Company - **Collaborators:** GlaxoSmithKline - **Conditions:** Systemic Lupus Erythematosus - **Start Date:** 2008-05-30 - **Completion Date:** 2016-12-09 - **CT.gov Last Update:** 2019-12-05 ## Brief Summary This is a long-term continuation study to provide continuing treatment to subjects with SLE. ## Detailed Description This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE). ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively. Exclusion Criteria: * Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician. ``` ## Arms - **1** (EXPERIMENTAL) — 1 mg/kg dose of belimumab given IV every 28 days. - **2.** (EXPERIMENTAL) — 10 mg/kg dose of belimumab given IV every 28 days. ## Interventions - **belimumab** (DRUG) — Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days. ## Primary Outcomes - **Number of Participants With Adverse Events (AE)** _(time frame: Up to 9 years)_ — An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized. - **AE Rates by System Organ Class (SOC) During the Study** _(time frame: Up to 9 years)_ — AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study. - **Number of Participants With Serious Adverse Events (SAE)** _(time frame: Up to 9 years)_ — An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized. - **SAE Rates by SOC During the Study** _(time frame: Up to 9 years)_ — SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study. - **Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point - **Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Hematocrit at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. - **Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in BUN and Glucose at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points** _(time frame: Baseline and up to 9 years)_ — Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels** _(time frame: Baseline and up to 9 years)_ — Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Bilirubin (Bili) Levels** _(time frame: Baseline and up to 9 years)_ — Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Change From Baseline in Immunoglobulin G (IgG) Levels** _(time frame: Baseline and up to 9 years)_ — Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. - **Number of Participants With Immunogenic Response by Year** _(time frame: Up to 9 years)_ — Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. - **Number of Participants With IgG Values Below the Lower Limit of Normal by Year** _(time frame: Up to 9 years)_ — Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. - **Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit** _(time frame: Up to 9 years)_ — Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized. - **Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit** _(time frame: Up to 9 years)_ — The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. ## Locations (110) - GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina - GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina - GSK Investigational Site, La Plata, Buenos Aires, Argentina - GSK Investigational Site, Rosario, Santa Fe Province, Argentina - GSK Investigational Site, San Miguel de Tucumán, Tucumán Province, Argentina - GSK Investigational Site, Buenos Aires, Argentina - GSK Investigational Site, Buenos Aires, Argentina - GSK Investigational Site, Ciudad Autonoma Buenos Aires, Argentina - GSK Investigational Site, Vienna, Austria - GSK Investigational Site, Liège, Belgium - GSK Investigational Site, Salvador, Estado de Bahia, Brazil - GSK Investigational Site, Goiânia, Goiás, Brazil - GSK Investigational Site, Juiz de Fora, Minas Gerais, Brazil - GSK Investigational Site, Recife, Pernambuco, Brazil - GSK Investigational Site, Porto Alegre, Rio Grande do Sul, Brazil - GSK Investigational Site, São Paulo, São Paulo, Brazil - GSK Investigational Site, Campinas, Brazil - GSK Investigational Site, Rio de Janeiro, Brazil - GSK Investigational Site, São Paulo, Brazil - GSK Investigational Site, São Paulo, Brazil - GSK Investigational Site, Toronto, Ontario, Canada - GSK Investigational Site, Montreal, Quebec, Canada - GSK Investigational Site, Viña del Mar, Valparaiso, Chile - GSK Investigational Site, Santiago, Chile - GSK Investigational Site, Barranquilla, Colombia - GSK Investigational Site, Bogotá, Colombia - GSK Investigational Site, Bucaramanga, Colombia - GSK Investigational Site, Medellín, Colombia - GSK Investigational Site, Brno-Bohunice, Czechia - GSK Investigational Site, Hradec Králové, Czechia - GSK Investigational Site, Olomouc, Czechia - GSK Investigational Site, Prague, Czechia - GSK Investigational Site, Suresnes, France - GSK Investigational Site, Freiburg im Breisgau, Baden-Wurttemberg, Germany - GSK Investigational Site, Erlangen, Bavaria, Germany - GSK Investigational Site, Frankfurt am Main, Hesse, Germany - GSK Investigational Site, Hanover, Lower Saxony, Germany - GSK Investigational Site, Mainz, Rhineland-Palatinate, Germany - GSK Investigational Site, Leipzig, Saxony, Germany - GSK Investigational Site, Jena, Thuringia, Germany - GSK Investigational Site, Berlin, Germany - GSK Investigational Site, Berlin, Germany - GSK Investigational Site, Kiel, Germany - GSK Investigational Site, Chai Wan, Hong Kong - GSK Investigational Site, New Territories, Hong Kong - GSK Investigational Site, Bangalore, India - GSK Investigational Site, Hyderabad, Andhra Pradesh, India - GSK Investigational Site, Lucknow, India - GSK Investigational Site, Secunderabad, India - GSK Investigational Site, Trivandrum, India - GSK Investigational Site, Beersheba, Israel - GSK Investigational Site, Haifa, Israel - GSK Investigational Site, Haifa, Israel - GSK Investigational Site, Haifa, Israel - GSK Investigational Site, Petah Tikva, Israel - GSK Investigational Site, Ramat Gan, Israel - GSK Investigational Site, Rehovot, Israel - GSK Investigational Site, Roma, Italy - GSK Investigational Site, Guadalajara, Jalisco, Mexico - GSK Investigational Site, Guadalajara, Jalisco, Mexico - GSK Investigational Site, México, Mexico - GSK Investigational Site, San Luis Potosí City, Mexico - GSK Investigational Site, Maastricht, Netherlands - GSK Investigational Site, Rotterdam, Netherlands - GSK Investigational Site, Rotterdam, Netherlands - GSK Investigational Site, Surco, Lima region, Peru - GSK Investigational Site, Callao, Peru - GSK Investigational Site, Lima, Peru - GSK Investigational Site, Cebu City, Philippines - GSK Investigational Site, Davao City, Philippines - GSK Investigational Site, Las Piñas, Philippines - GSK Investigational Site, Manila, Philippines - GSK Investigational Site, Quezon City, Philippines - GSK Investigational Site, Sampaloc Manila, Philippines - GSK Investigational Site, Gmina Końskie, Poland - GSK Investigational Site, Ponce, Puerto Rico - GSK Investigational Site, San Juan, Puerto Rico - GSK Investigational Site, Bucharest, Romania - GSK Investigational Site, Bucharest, Romania - GSK Investigational Site, Bucharest, Romania - GSK Investigational Site, Cluj-Napoca, Romania - GSK Investigational Site, Moscow, Russia - GSK Investigational Site, Saint Petersburg, Russia - GSK Investigational Site, Saint Petersburg, Russia - GSK Investigational Site, Saint Petersburg, Russia - GSK Investigational Site, Yaroslavl, Russia - GSK Investigational Site, Yaroslavl, Russia - GSK Investigational Site, Piešťany, Slovakia - GSK Investigational Site, Busan, South Korea - GSK Investigational Site, Daejeon, South Korea - GSK Investigational Site, Incheon, South Korea - GSK Investigational Site, Pusan, South Korea - GSK Investigational Site, Seoul, South Korea - GSK Investigational Site, Seoul, South Korea - GSK Investigational Site, Suwon, Kyonggi-do, South Korea - GSK Investigational Site, Barcelona, Spain - GSK Investigational Site, Madrid, Spain - GSK Investigational Site, Stockholm, Sweden - GSK Investigational Site, Dalin Township, Chiayi County, Taiwan - GSK Investigational Site, Gueishan Township,Taoyuan County, Taiwan - GSK Investigational Site, Hualien City, Taiwan - GSK Investigational Site, Kaohsiung City, Taiwan - GSK Investigational Site, Kaohsiung City, Taiwan - GSK Investigational Site, Kaohsiung City, Taiwan - GSK Investigational Site, Taichung, Taiwan - GSK Investigational Site, Taichung, Taiwan - GSK Investigational Site, Taichung, Taiwan - GSK Investigational Site, Taipei, Taiwan - GSK Investigational Site, London, United Kingdom - GSK Investigational Site, Newcastle upon Tyne, United Kingdom ## Recent Field Changes (last 30 days) - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.gsk investigational site|ciudad autonoma de buenos aires|buenos aires|argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|la plata|buenos aires|argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|rosario|santa fe province|argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|san miguel de tucumán|tucumán province|argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|buenos aires||argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|ciudad autonoma buenos aires||argentina` — added _(2026-05-12)_ - `locations.gsk investigational site|vienna||austria` — added _(2026-05-12)_ - `locations.gsk investigational site|liège||belgium` — added _(2026-05-12)_ - `locations.gsk investigational site|salvador|estado de bahia|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|goiânia|goiás|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|juiz de fora|minas gerais|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|recife|pernambuco|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|porto alegre|rio grande do sul|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|são paulo|são paulo|brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|campinas||brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|rio de janeiro||brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|são paulo||brazil` — added _(2026-05-12)_ - `locations.gsk investigational site|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.gsk investigational site|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.gsk investigational site|viña del mar|valparaiso|chile` — added _(2026-05-12)_ - `locations.gsk investigational site|santiago||chile` — added _(2026-05-12)_ - `locations.gsk investigational site|barranquilla||colombia` — added _(2026-05-12)_ - `locations.gsk investigational site|bogotá||colombia` — added _(2026-05-12)_ - `locations.gsk investigational site|bucaramanga||colombia` — added _(2026-05-12)_ - `locations.gsk investigational site|medellín||colombia` — added _(2026-05-12)_ - `locations.gsk investigational site|brno-bohunice||czechia` — added _(2026-05-12)_ - `locations.gsk investigational site|hradec králové||czechia` — added _(2026-05-12)_ - `locations.gsk investigational site|olomouc||czechia` — added _(2026-05-12)_ - `locations.gsk investigational site|prague||czechia` — added _(2026-05-12)_ - `locations.gsk investigational site|suresnes||france` — added _(2026-05-12)_ - `locations.gsk investigational site|freiburg im breisgau|baden-wurttemberg|germany` — added _(2026-05-12)_ - `locations.gsk investigational site|erlangen|bavaria|germany` — added _(2026-05-12)_ - `locations.gsk investigational site|frankfurt am main|hesse|germany` — added _(2026-05-12)_ - `locations.gsk investigational site|hanover|lower saxony|germany` — added _(2026-05-12)_ - `locations.gsk investigational site|mainz|rhineland-palatinate|germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00712933.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00712933* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*