Safety Study of Galantamine in Tic Disorders

Phase 4

Terminated

• Conditions: Tourette's Syndrome; Motor Tic Disorder; Vocal Tic Disorder

• Registration Number: NCT00226824
• Lead Sponsor: 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.

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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Study Completion: 2007-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-21
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment related adverse experience
Severity Score of the Yale Global Tic Severity Scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parkinson's Disease and Movement Disorders Center of Albany Medical Center; 🇺🇸 Albany, New York, United States