Full Text View
Tabular View
No Study Results Posted
Related Studies
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
This study is ongoing, but not recruiting participants.
First Received: November 14, 2007   Last Updated: June 25, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00558467
  Purpose

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.


Condition Intervention Phase
Tourette Syndrome
Drug: pramipexole IR
Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Mean change from baseline of the TTS of the YGTSS after 6 weeks of treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • YGTSS [ Time Frame: 6 weeks ]

Estimated Enrollment: 63
Study Start Date: January 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558467

Locations
United States, Florida
248.644.0025 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
248.644.0026 Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
248.644.0028 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
United States, Georgia
248.644.0006 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
United States, Illinois
248.644.0012 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Massachusetts
248.644.0005 Boehringer Ingelheim Investigational Site
Cambridge, Massachusetts, United States
United States, New York
248.644.0001 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
248.644.0003 Boehringer Ingelheim Investigational Site
Manhasset, New York, United States
248.644.0009 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.644.0013 Boehringer Ingelheim Investigational Site
Orangeburg, New York, United States
248.644.0018 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, Oklahoma
248.644.0029 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Rhode Island
248.644.0010 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, Tennessee
248.644.0030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
United States, Texas
248.644.0008 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
248.644.0032 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Virginia
248.644.0023 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
Germany
248.644.49001 Boehringer Ingelheim Investigational Site
Hannover, Germany
248.644.49004 Boehringer Ingelheim Investigational Site
Ulm, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.644
Study First Received: November 14, 2007
Last Updated: June 25, 2009
ClinicalTrials.gov Identifier: NCT00558467     History of Changes
Health Authority: Germany: BfArM-Federal Authorities for Drugs and Medical Devices;   United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Antioxidants
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pramipexol
Tics
Dopamine
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Dopamine Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Neurodegenerative Diseases
Brain Diseases
Pramipexol
Heredodegenerative Disorders, Nervous System
Pathologic Processes
Movement Disorders
Mental Disorders
Syndrome
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Disease
Nervous System Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Protective Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009