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Comparison of Keppra and Clonidine in the Treatment of Tics
This study is currently recruiting participants.
Verified by Johns Hopkins University, April 2007
Sponsors and Collaborators: Johns Hopkins University
UCB
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

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome
MedlinePlus related topics: Tourette Syndrome
Drug Information available for: Clonidine Levetiracetam Clonidine hydrochloride
U.S. FDA Resources
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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Yale Global Tic Severity Scale (YGTSS):

Secondary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI-I):
  • Child Yale-Brown Obsessive Compulsive Scale:
  • DuPaul ADHD Rating Scale:
  • Multidimensional Anxiety Scale for Children (MASC):
  • Pittsburgh Side Effect Scale

Estimated Enrollment: 20
Study Start Date: February 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be included in this study if they meet the following criteria:

  • Tourette syndrome criteria based on the TS Classification Study Group [1993], which includes onset before 18 years, multiple involuntary motor tics, one or more vocal tics, a waxing and waning course, the gradual replacement of old symptoms with new ones, the presence of tics for more than one year, the absence of other medical explanations for tics, and observation of tics by a reliable examiner;
  • Age 7 to 19 years, either gender;
  • Observable tics, achieving a minimum score of > 22 on the Total Tic score of Yale Global Tic Severity Scale (YGTSS);
  • Tic symptoms severe enough to warrant therapy;
  • The concurrent use of other tic-suppressing medications will be permitted, if the subject has been on a stable dose for more than three weeks and agrees to maintain a constant dosage throughout the study;
  • Tics are not controlled with current medication or individuals are tic suppressing drug naive.

Exclusion Criteria:

Exclusion criteria include the following:

  • Secondary tics;
  • Significant medical illness
  • Current major depression, generalized anxiety disorder, separation anxiety disorder, psychotic symptoms (based on clinical evaluation), pervasive developmental disorder, autism, mental retardation (I.Q. less than 70), anorexia/bulimia, or substance abuse. Subjects with co-morbid ADHD, obsessive compulsive disorder (OCD), and conduct disorder will not be excluded;
  • pregnancy;
  • Hypersensitivity to levetiracetam or clonidine;
  • baseline weight of less than 25 kilograms.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370838

Contacts
Contact: Harvey S Singer, MD 410-955-7212 hsinger@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Harvey S Singer, MD            
Principal Investigator: Harvey S Singer, MD            
Sponsors and Collaborators
Johns Hopkins University
UCB
Investigators
Principal Investigator: Harvey S Singer, MD Johns Hopkins University
  More Information

Study ID Numbers: TSkepclon
Study First Received: August 30, 2006
Last Updated: April 5, 2007
ClinicalTrials.gov Identifier: NCT00370838  
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Tics
Tourette syndrome
levetiracetam
clonidine

Study placed in the following topic categories:
Ganglion Cysts
Clonidine
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Neurodegenerative Diseases
Brain Diseases
Dyskinesias
Tics
Signs and Symptoms
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Etiracetam
Gilles de la Tourette's syndrome

Additional relevant MeSH terms:
Nootropic Agents
Sympatholytics
Neurotransmitter Agents
Disease
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Syndrome
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009