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Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
This study has been completed.
Study NCT00558467   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: November 14, 2007   Last Updated: July 20, 2009   History of Changes

November 14, 2007
July 20, 2009
January 2008
June 2009   (final data collection date for primary outcome measure)
Mean change from baseline of the TTS of the YGTSS after 6 weeks of treatment [ Time Frame: 6 weeks ]
Mean change from baseline of the TTS of the YGTSS after 6 weeks of treatment
Complete list of historical versions of study NCT00558467 on ClinicalTrials.gov Archive Site
YGTSS [ Time Frame: 6 weeks ]
YGTSS
 
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
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.

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.

 
Phase II
Interventional
Treatment, Parallel Assignment, Safety/Efficacy Study
Tourette Syndrome
Drug: pramipexole IR
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
63
 
June 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00558467
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
248.644
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP