--- title: "Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia" nct_id: NCT00105508 overall_status: COMPLETED phase: PHASE3 sponsor: EMD Serono study_type: INTERVENTIONAL primary_condition: "Parkinson's Disease" countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00105508.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00105508" ct_last_update_post_date: 2018-07-26 last_seen_at: "2026-05-12T07:34:44.162Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia **Official Title:** A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia **NCT ID:** [NCT00105508](https://clinicaltrials.gov/study/NCT00105508) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 506 - **Lead Sponsor:** EMD Serono - **Conditions:** Parkinson's Disease, Dyskinesia - **Start Date:** 2004-09-30 - **Completion Date:** 2006-02-28 - **CT.gov Last Update:** 2018-07-26 ## Brief Summary The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD). ## Eligibility - **Minimum age:** 30 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * The subject is an out-patient. * The subject presents with a diagnosis of idiopathic Parkinson's disease. * Prior therapy with all registered Parkinsonian medication is allowed. Exclusion Criteria: * (For female subjects) The subject is pregnant or lactating. * The subject is participating in another clinical study or has done so within the past 30 days. * The subject has received neurosurgical intervention related to PD. * The subject has relevant renal impairment. * The subject has relevant hepatic impairment. * The subject is suffering from any dementia or psychiatric illness. * The subject has a history of allergic asthma. ``` ## Arms - **Sarizotan** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **Sarizotan** (DRUG) — Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. - **Placebo** (DRUG) — Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks. ## Primary Outcomes - **Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12** _(time frame: Week 12)_ — Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia. - **Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24** _(time frame: Week 24)_ — Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia. - **Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12** _(time frame: Baseline, Week 12)_ — The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline. - **Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24** _(time frame: Baseline, Week 24)_ — The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline. ## Locations (31) - Birmingham, Alabama, United States - Huntsville, Alabama, United States - La Jolla, California, United States - Oxnard, California, United States - Sacramento, California, United States - Englewood, Colorado, United States - Danbury, Connecticut, United States - Farmington, Connecticut, United States - Jacksonville, Florida, United States - Jacksonville, Florida, United States - Maitland, Florida, United States - St. Petersburg, Florida, United States - Decatur, Georgia, United States - Chicago, Illinois, United States - Springfield, Illinois, United States - Des Moines, Iowa, United States - New Orleans, Louisiana, United States - Scarborough, Maine, United States - Boston, Massachusetts, United States - Southfield, Michigan, United States - Edison, New Jersey, United States - New Hyde Park, New York, United States - New Hyde Park, New York, United States - New York, New York, United States - Durham, North Carolina, United States - Oklahoma City, Oklahoma, United States - Pittsburgh, Pennsylvania, United States - Brentwood, Tennessee, United States - South Ogden, Utah, United States - Spokane, Washington, United States - Milwaukee, Wisconsin, United States ## Recent Field Changes (last 30 days) - `locations.|sacramento|california|united states` — added _(2026-05-12)_ - `locations.|englewood|colorado|united states` — 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)_ - `eligibility.sex` — 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)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.|huntsville|alabama|united states` — added _(2026-05-12)_ - `locations.|la jolla|california|united states` — added _(2026-05-12)_ - `locations.|oxnard|california|united states` — added _(2026-05-12)_ - `locations.|danbury|connecticut|united states` — added _(2026-05-12)_ - `locations.|farmington|connecticut|united states` — added _(2026-05-12)_ - `locations.|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.|maitland|florida|united states` — added _(2026-05-12)_ - `locations.|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.|decatur|georgia|united states` — added _(2026-05-12)_ - `locations.|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.|springfield|illinois|united states` — added _(2026-05-12)_ - `locations.|des moines|iowa|united states` — added _(2026-05-12)_ - `locations.|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.|scarborough|maine|united states` — added _(2026-05-12)_ - `locations.|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.|southfield|michigan|united states` — added _(2026-05-12)_ - `locations.|edison|new jersey|united states` — added _(2026-05-12)_ - `locations.|new hyde park|new york|united states` — added _(2026-05-12)_ - `locations.|new york|new york|united states` — added _(2026-05-12)_ - `locations.|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|brentwood|tennessee|united states` — added _(2026-05-12)_ - `locations.|south ogden|utah|united states` — added _(2026-05-12)_ - `locations.|spokane|washington|united states` — added _(2026-05-12)_ - `locations.|milwaukee|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00105508.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00105508* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*