Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00681863 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT00681863: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00681863 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00681863, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).
Primary Outcome
Number of patients with Adverse Events leading to discontinuation of trial drug
Interventions
- DRUG pramipexole 0.125 mg BID
- DRUG pramipexole 0.0625 mg QD
- DRUG pramipexole 0.125 mg TID
- DRUG pramipexole 0.25 mg BID
- DRUG pramipexole 0.0625 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-05 |
| Phase | Phase 3 |
Why NCT00681863 stopped before completion
NCT00681863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which pramipexole 0.125 mg BID is the first listed.
NCT00681863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00681863 about?
NCT00681863 is a clinical study titled "Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome". The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edit...
What is the current status of trial NCT00681863?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2008-05.
What interventions are being tested in trial NCT00681863?
The interventions under investigation include: pramipexole 0.125 mg BID (DRUG), pramipexole 0.0625 mg QD (DRUG), pramipexole 0.125 mg TID (DRUG), pramipexole 0.25 mg BID (DRUG), pramipexole 0.0625 mg BID (DRUG).
Who is sponsoring clinical trial NCT00681863?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00681863's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia