Safety Study of Galantamine in Tic Disorders

This study has been terminated.
(Unable to recruit subjects into the trial.)
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Parkinson's Disease and Movement Disorders Center
ClinicalTrials.gov Identifier:
NCT00226824
First received: September 23, 2005
Last updated: August 21, 2009
Last verified: August 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Examination of Galantamine in the Management of Tic Disorders

Resource links provided by NLM:


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

Publications:
ClinicalTrials.gov Identifier: NCT00226824     History of Changes
Other Study ID Numbers: GAL-EMR-4017
Study First Received: September 23, 2005
Last Updated: August 21, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 21, 2014