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| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborator: |
UCB, Inc. |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00370838 |
Purpose
The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile than that of the widely used tic-suppressing medication, clonidine. More specifically, we hypothesize that in a 15 week placebo run-in, double-blind, medication cross-over trial; levetiracetam will be more effective and have fewer side-effects than clonidine.
| Condition | Intervention | Phase |
|---|---|---|
|
Tic Disorders Tourette Syndrome |
Drug: levetiracetam and clonidine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Keppra and Clonidine in the Treatment of Tics in Children With Tourette Syndrome |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 7 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be included in this study if they meet the following criteria:
Exclusion Criteria:
Exclusion criteria include the following:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Harvey S Singer, MD | Johns Hopkins University |
More Information
| Study ID Numbers: | TSkepclon |
| Study First Received: | August 30, 2006 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00370838 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Tics Tourette syndrome levetiracetam clonidine |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Adrenergic Agonists Tics Signs and Symptoms Pathologic Processes Heredodegenerative Disorders, Nervous System Sensory System Agents Mental Disorders Movement Disorders |
Therapeutic Uses Syndrome Mental Disorders Diagnosed in Childhood Analgesics Nootropic Agents Sympatholytics Disease Adrenergic alpha-Agonists Nervous System Diseases Clonidine Central Nervous System Diseases Tourette Syndrome Cardiovascular Agents Tic Disorders Antihypertensive Agents |