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| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| 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 |
|
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 |
|
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 |