Conditions: Tourette Syndrome
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

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:

Arms:
arm 1: all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) arm 2: patients to receive one tablet of pramipexole 0.0625 mg QD arm 3: patients to receive one tablet of pramipexole 0.125 mg BID arm 4: patients to receive one tablet of pramipexole 0.125 mg TID arm 5: patients to receive one tablet of pramipexole 0.25 mg BID

Interventions: intervention 1: pramipexole 0.125 mg BID intervention 2: pramipexole 0.0625 mg QD intervention 3: pramipexole 0.125 mg TID intervention 4: pramipexole 0.25 mg BID intervention 5: pramipexole 0.0625 mg BID
Intervention descriptions: intervention 1: titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose intervention 2: dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing intervention 3: titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose intervention 4: titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose intervention 5: 0.0625 mg BID given for first 4 wks of treatment

Protocol document: