--- title: A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder nct_id: NCT00965419 overall_status: TERMINATED phase: PHASE2, PHASE3 sponsor: Eli Lilly and Company study_type: INTERVENTIONAL primary_condition: Attention Deficit Hyperactivity Disorder countries: United States, Canada, Puerto Rico, Taiwan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00965419.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00965419" ct_last_update_post_date: 2019-10-08 last_seen_at: "2026-05-12T06:30:30.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder **Official Title:** Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder **NCT ID:** [NCT00965419](https://clinicaltrials.gov/study/NCT00965419) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Terminated due to low 5 year completer number and not meeting primary objective. - **Phase:** PHASE2, PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 267 - **Lead Sponsor:** Eli Lilly and Company - **Conditions:** Attention Deficit Hyperactivity Disorder - **Start Date:** 2009-09 - **Completion Date:** 2015-07 - **CT.gov Last Update:** 2019-10-08 ## Brief Summary The primary purpose of the study is to assess long-term safety and tolerability of Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD). ## Eligibility - **Minimum age:** 6 Years - **Maximum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` INCLUSION CRITERIA: -Participants must meet Diagnostic and Statistical Manual of Mental Disorders 4th Ed (DSM-IV) diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined subtypes) based on an interview by an experienced clinician and confirmed using the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present (SADS) and Lifetime Version (K-SADS-PL) at Visit 1 for new participants and in the parent trial for rollover participants. -Participants must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard deviations above the age/gender norm at both screening/randomization. New participants must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder- Severity (CGI-ADHD-S) score greater than or equal to 4 at both screening/randomization. * Participants of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female participants of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test. * Participants must have laboratory results, showing no clinically significant abnormalities. * Parents/participants must have a degree of understanding sufficient to communicate suitably with the investigator/ study coordinator. * Participants must be of normal intelligence. * Participants/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits/all tests, including venipunctures and examinations required by the protocol. * Participants must be able to swallow tablets. EXCLUSION CRITERIA: * Participants who weigh less than 16 kg at screening/randomization. * Female participants who are pregnant/breastfeeding. * Participants who have previously withdrawn/discontinued early from this study or any other study investigating Edivoxetine. * Participants who have a history of Bipolar I/II disorder, psychosis, or pervasive developmental disorder. * Participants with a history of any seizure disorder or known electroencephalographic (EEG) abnormalities in the absence of seizures. * Participants who are at serious suicidal risk. * Participants with a history of severe allergies to more than 1 class of medications, or multiple adverse drug reactions, or known hypersensitivity to Edivoxetine. * Participants with a history of alcohol or drug abuse/dependence within the past 3 months of screening, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence. * Participants who screen positive for drugs of abuse cannot participate. * Participants who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. * Participants with problems that would be exacerbated by increased norepinephrine tone including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or urinary retention. * Participants who at any time during the study are likely to need psychotropic medications apart from the drugs under study. * Participants who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization. * Participants with current or past history of clinically significant hypertension. * Participants who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Participants whose family anticipates a move outside the geographic range of the investigative site during participation in the study or who plan extended travel inconsistent with the recommended visit intervals. * Participants who, in the opinion of the investigator, are unsuitable in any other way to participate in this study. ``` ## Arms - **Edivoxetine** (EXPERIMENTAL) — All enrolled participants were administered starting dose of 0.1 milligram per kilogram per day (mg/kg/day), or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years. ## Interventions - **Edivoxetine** (DRUG) — 0.1 mg/kg/day or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years. ## Primary Outcomes - **Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study** _(time frame: Baseline Through Week 252)_ — Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. - **Number of Participants With At Least One SAE** _(time frame: Baseline Through Week 252)_ — Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. ## Secondary Outcomes - **Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)** _(time frame: Baseline Through Week 252)_ - **Number of Participants With At Least One TEAE** _(time frame: Baseline Through Week 252)_ - **Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)** _(time frame: Baseline Through Week 252)_ - **Number of Participants With At Least One DCAEs** _(time frame: Baseline Through Week 252)_ - **Percentage of Participants Who Discontinued Due to Any Reason** _(time frame: Baseline Through Week 252)_ - **Number of Participants Who Discontinued Due to Any Reason** _(time frame: Baseline Through Week 252)_ - **Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category** _(time frame: Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u))_ - **Mean Change From Baseline Z-scores for Height** _(time frame: Baseline, Week 60; Baseline, Week 240)_ - **Mean Change From Baseline Z-Score for Weight** _(time frame: Baseline, Week 60; Baseline, Week 240)_ - **Mean Change From Baseline Z-Score in Body Mass Index (BMI)** _(time frame: Baseline, Week 60; Baseline, Week 240)_ - **Percentage of Participants With Response Rates** _(time frame: Week 12)_ - **Number of Participants With a Response Rate** _(time frame: Week 12)_ - **Survival Curve Time to Response** _(time frame: Week 12)_ - **Percentage of Participants in Sexual Maturation on Tanners Scale** _(time frame: Baseline Up to Week 252)_ - **Number of Participants in Sexual Maturation on Tanners Scale** _(time frame: Baseline Up to Week 252)_ - **Percentage of Participants With Tobacco, Alcohol and Marijuana Use** _(time frame: Week 60 through Week 252)_ - **Number of Participants With Tobacco, Alcohol and Marijuana Use** _(time frame: Week 60 through Week 252)_ - **Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)** _(time frame: Baseline, Week 12)_ - **Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale** _(time frame: Baseline, Week 12)_ - **Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode** _(time frame: Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156)_ - **Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156)_ - **Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Total Score EQ-5D-3L VAS** _(time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)_ - **Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])** _(time frame: Baseline, Week 60)_ - **Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)** _(time frame: Baseline, Week 60)_ - **Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)** _(time frame: Baseline, Week 60)_ - **Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)** _(time frame: Baseline, Week 60)_ ## Locations (19) - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Spring Valley, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gainesville, Florida, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Orlando, Florida, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., University Park, Florida, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Smyrna, Georgia, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Libertyville, Illinois, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rochester Hills, Michigan, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Omaha, Nebraska, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Las Vegas, Nevada, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Philadelphia, Pennsylvania, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Memphis, Tennessee, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lake Jackson, Texas, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lubbock, Texas, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Herndon, Virginia, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seattle, Washington, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kelowna, British Columbia, Canada - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Santurce, Puerto Rico - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kuei Shan Hsiang, Taiwan ## Recent Field Changes (last 30 days) - `outcomes.secondary` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — 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.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|spring valley|california|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|orlando|florida|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|university park|florida|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|smyrna|georgia|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|libertyville|illinois|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|rochester hills|michigan|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|memphis|tennessee|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|lake jackson|texas|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|lubbock|texas|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|herndon|virginia|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|seattle|washington|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|kelowna|british columbia|canada` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|santurce||puerto rico` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|kuei shan hsiang||taiwan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00965419.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00965419* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*