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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 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 45 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00681863
The ClinicalTrials.gov registry entry for NCT00681863 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which pramipexole 0.125 mg BID is the first listed.
NCT00681863 reports 0 study locations.
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.
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