Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
- Conditions
- Tourette Syndrome
- Interventions
- Registration Number
- NCT00681863
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pramipexole 0.125 mg BID pramipexole 0.125 mg BID patients to receive one tablet of pramipexole 0.125 mg BID pramipexole 0.125 mg TID (three times daily) pramipexole 0.125 mg TID patients to receive one tablet of pramipexole 0.125 mg TID pramipexole 0.0625 mg QD (once daily) pramipexole 0.0625 mg QD patients to receive one tablet of pramipexole 0.0625 mg QD pramipexole 0.0625 mg BID (twice daily) pramipexole 0.0625 mg BID all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) pramipexole 0.25 mg BID pramipexole 0.25 mg BID patients to receive one tablet of pramipexole 0.25 mg BID
- Primary Outcome Measures
Name Time Method Patients With Adverse Events Leading to Discontinuation of Trial Drug 24 Weeks Number of patients with Adverse Events leading to discontinuation of trial drug
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale baseline and Week 20 Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale baseline and Week 24 Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
Clinical Global Impressions - Severity of Illness week 24 Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Clinical Global Impressions - Severity of Illness, Categorized week 24 Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.Clinical Global Impressions - Improvement week 24 Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Patient Global Impression - Improvement week 24 Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters Baseline and 24 weeks Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)
Trial Locations
- Locations (14)
248.642.0013 Boehringer Ingelheim Investigational Site
🇺🇸Orangeburg, New York, United States
248.642.0010 Boehringer Ingelheim Investigational Site
🇺🇸Providence, Rhode Island, United States
248.642.0029 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
248.642.0003 Boehringer Ingelheim Investigational Site
🇺🇸Manhasset, New York, United States
248.642.0006 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
248.642.0025 Boehringer Ingelheim Investigational Site
🇺🇸Tampa, Florida, United States
248.642.0030 Boehringer Ingelheim Investigational Site
🇺🇸Memphis, Tennessee, United States
248.642.0009 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
248.642.0018 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
248.642.49004 Boehringer Ingelheim Investigational Site
🇩🇪Ulm, Germany
248.642.0008 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
248.642.0026 Boehringer Ingelheim Investigational Site
🇺🇸Bradenton, Florida, United States
248.642.0023 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
248.642.0005 Boehringer Ingelheim Investigational Site
🇺🇸Cambridge, Massachusetts, United States