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Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

This study is currently recruiting participants.
Study NCT00558467.   Last updated on November 20, 2008.   Information provided by Boehringer Ingelheim Pharmaceuticals

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Descriptive Information Fields
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 IR (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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Mean change from baseline of the TTS of the YGTSS after 6 weeks of treatment [ Time Frame: 6 weeks ]
Secondary Outcome Measure  YGTSS [ Time Frame: 6 weeks ]
Condition  Tourette Syndrome
Intervention  Drug: pramipexole IR
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  54
Start Date  January 2008
Completion Date
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;TSH, T3 or 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 DSM-IV requiring any medical therapy except for patients with a diagnosis of ADHD or 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 KBIT IQ score <70 at screening.
  • Having a CY-BOCS score of >15 at baseline.
  • Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder.
  • Patients with 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 Both
Ages 6 Years to 17 Years
Accepts Healthy Volunteers
Contacts ††
Contact: Boehringer Ingelheim Study Coordinator         clintriage.rdg@boehringer-ingelheim.com    
Location Countries  United States,   Germany
Administrative Information Fields
NCT ID  NCT00558467
Organization ID 248.644
Secondary IDs ††
Study Sponsor  Boehringer Ingelheim Pharmaceuticals
Collaborators ††
Investigators 
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
Information Provided By Boehringer Ingelheim Pharmaceuticals
Verification Date November 2008
First Received Date  November 14, 2007
Last Updated Date November 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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