Brief Title
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Official Title
A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
Brief Summary
A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Secondary Outcome
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Condition
Tourette Syndrome
Intervention
pramipexole immediate release (IR)
Study Arms / Comparison Groups
Pramipexole
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
63
Start Date
January 2008
Primary Completion Date
June 2009
Eligibility Criteria
Inclusion Criteria: - Male of female patients 6-17 yrs. - Written informed consent. - Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline. - Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children. - Having at least 1 tic/day. - Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method. - Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment. - Having a body weight of > or equal to 20 kg (44 lbs). Exclusion Criteria: - Any women of childbearing age having a positive serum pregnancy test at screening. - Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening. - Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs. - Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study. - History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy. - History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood. - History of/or clinical signs of any malignant neoplasm. - Allergic response to pramipexole. - Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit. - Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit. - Had withdrawal symptoms of any medication at screening or at the baseline visit. - Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening. - Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline. - Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder. - Patients with severe asthma. - Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial. - Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan.
Gender
All
Ages
6 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
Boehringer Ingelheim, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00558467
Organization ID
248.644
Responsible Party
Sponsor
Study Sponsor
Boehringer Ingelheim
Study Sponsor
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Verification Date
March 2014