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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00681863 |
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed either Study 248.641 or 248.644.
Condition | Intervention | Phase |
---|---|---|
Tourette Syndrome |
Drug: pramipexole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | OL Extension Study With PPX in Children With Tourette Syndrome |
Estimated Enrollment: | 148 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following lab results at screening:
Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion) Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion.
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.642, EUDRACT2008-000342-32 |
Study First Received: | May 19, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00681863 |
Health Authority: | Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica); Brazil: Comitê Nacional de Ética em Pesquisa Clínica - CONEP; Canada: Health Canada; Germany: BfArM-Federal Authorities for Drugs and Medical Devices; Great Britain: MHRA; Italy: San Raffaele Hospital - Rome; South Africa: MCC (Medicines Control Council); Spain: Agencia Espanola del Medicamento y Productos Sanitarios; United States: Food and Drug Administration |
Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Brain Diseases Neurodegenerative Diseases Pramipexol |
Tics Dopamine Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Movement Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Gilles de la Tourette's syndrome |
Neurotransmitter Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Dopamine Agents Central Nervous System Agents |