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Safety Study of Galantamine in Tic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226824
Recruitment Status : Terminated (Unable to recruit subjects into the trial.)
First Posted : September 27, 2005
Last Update Posted : August 25, 2009
Ortho-McNeil Neurologics, Inc.
Information provided by:
Parkinson's Disease and Movement Disorders Center

Brief Summary:
The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.

Condition or disease Intervention/treatment Phase
Tourette's Syndrome Motor Tic Disorder Vocal Tic Disorder Drug: galantamine Phase 4

Detailed Description:

Modulation of cholinergic activity is a growing focus in neurologic therapeutics especially for dementing disorders such as Alzheimer disease. Treatment with the recently developed cholinesterase inhibitor, galantamine, has demonstrated significant improvement with few issues related to tolerability. In addition to inhibiting the activity of acetylcholinesterase, galantamine also modulates the activity of nicotinic cholinergic receptors by an allosteric mechanism. As a result, galantamine therapy may be beneficial when the response to other agents has been limited.

Cholinesterase inhibitor therapy has been reported to improve motor tics in children with TS refractory to more traditional therapies. Symptoms of co-morbid behavioral disorders, primarily inattention, were also improved. Cholinergic modulation appears a promising avenue for managing tic disorders.

Men and women (18 - 50 years of age) fulfilling DSM IV criteria for the diagnosis of chronic motor tic disorder, chronic vocal tic disorder or Tourette Syndrome and experiencing suboptimal control of tics on current therapy will be enrolled into this open label evaluation of galantamine. A total of 6 visits will be required over 22 weeks. Participants will follow a standard 4 week titration schedule achieving 12 mg bid after 8 weeks. They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy. The difference in tic severity prior to and upon completion of therapy will be examined. The impact of treatment upon obsessions/compulsions, attention/concentration, depression, anxiety and quality of life will also be determined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Examination of Galantamine in the Management of Tic Disorders
Study Start Date : September 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Treatment related adverse experience
  2. Severity Score of the Yale Global Tic Severity Scale

Secondary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Survey
  2. Connors Adult Attention Deficit Hyperactivity Rating Scale
  3. Hamilton Rating Scale for Depression
  4. Hamilton Rating Scale for Anxiety
  5. Short Form 36

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder
  • Accepted method of birth control

Exclusion Criteria:

  • Preganancy or nursing
  • Unstable medical illness
  • Unstable psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226824

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United States, New York
Parkinson's Disease and Movement Disorders Center of Albany Medical Center
Albany, New York, United States, 12205
Sponsors and Collaborators
Parkinson's Disease and Movement Disorders Center
Ortho-McNeil Neurologics, Inc.
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Principal Investigator: Donald S Higgins, M.D. Parkinson's Disease and Movement Disorder Center of Albany Medical Center
Layout table for additonal information Identifier: NCT00226824    
Other Study ID Numbers: GAL-EMR-4017
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Keywords provided by Parkinson's Disease and Movement Disorders Center:
Tourette's disorder
Additional relevant MeSH terms:
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Tourette Syndrome
Tic Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents