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Safety Study of Galantamine in Tic Disorders
This study has been terminated.
Sponsors and Collaborators: Parkinson's Disease and Movement Disorders Center
Ortho-McNeil Neurologics, Inc.
Information provided by: Parkinson's Disease and Movement Disorders Center
ClinicalTrials.gov Identifier: NCT00226824
  Purpose

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 Intervention Phase
Tourette's Syndrome
Motor Tic Disorder
Vocal Tic Disorder
Drug: galantamine
Phase IV

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome
MedlinePlus related topics: Movement Disorders Tourette Syndrome
Drug Information available for: Galantamine hydrobromide Galantamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Examination of Galantamine in the Management of Tic Disorders

Further study details as provided by Parkinson's Disease and Movement Disorders Center:

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

Secondary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Survey
  • Connors Adult Attention Deficit Hyperactivity Rating Scale
  • Hamilton Rating Scale for Depression
  • Hamilton Rating Scale for Anxiety
  • Short Form 36

Enrollment: 1
Study Start Date: September 2005
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226824

Locations
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.
Investigators
Principal Investigator: Donald S Higgins, M.D. Parkinson's Disease and Movement Disorder Center of Albany Medical Center
  More Information

Parkinson's Disease and Movement Disorders Center of Albany Medical Center  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: GAL-EMR-4017
Study First Received: September 23, 2005
Last Updated: May 8, 2007
ClinicalTrials.gov Identifier: NCT00226824  
Health Authority: United States: Institutional Review Board

Keywords provided by Parkinson's Disease and Movement Disorders Center:
Tourette's disorder
tic

Study placed in the following topic categories:
Ganglion Cysts
Galantamine
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
Gilles de la Tourette's syndrome

Additional relevant MeSH terms:
Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009