Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 45
- Locations
- 14
- Primary Endpoint
- Patients With Adverse Events Leading to Discontinuation of Trial Drug
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
pramipexole 0.0625 mg BID (twice daily)
all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms)
Intervention: pramipexole 0.0625 mg BID (Drug)
pramipexole 0.0625 mg QD (once daily)
patients to receive one tablet of pramipexole 0.0625 mg QD
Intervention: pramipexole 0.0625 mg QD (Drug)
pramipexole 0.125 mg BID
patients to receive one tablet of pramipexole 0.125 mg BID
Intervention: pramipexole 0.125 mg BID (Drug)
pramipexole 0.125 mg TID (three times daily)
patients to receive one tablet of pramipexole 0.125 mg TID
Intervention: pramipexole 0.125 mg TID (Drug)
pramipexole 0.25 mg BID
patients to receive one tablet of pramipexole 0.25 mg BID
Intervention: pramipexole 0.25 mg BID (Drug)
Outcomes
Primary Outcomes
Patients With Adverse Events Leading to Discontinuation of Trial Drug
Time Frame: 24 Weeks
Number of patients with Adverse Events leading to discontinuation of trial drug
Secondary Outcomes
- Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale(baseline and Week 20)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale(baseline and Week 24)
- Clinical Global Impressions - Severity of Illness(week 24)
- Clinical Global Impressions - Severity of Illness, Categorized(week 24)
- Clinical Global Impressions - Improvement(week 24)
- Patient Global Impression - Improvement(week 24)
- Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters(Baseline and 24 weeks)