Safety Study of Galantamine in Tic Disorders
Study Details
Study Description
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 |
|---|---|---|
| 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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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.
Study Design
Outcome Measures
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 []
Eligibility Criteria
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:
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Preganancy or nursing
-
Unstable medical illness
-
Unstable psychiatric illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. Review.
- Hayslett RL, Tizabi Y. Effects of donepezil on DOI-induced head twitch response in mice: implications for Tourette syndrome. Pharmacol Biochem Behav. 2003 Dec;76(3-4):409-15.
- Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2.
- Wilens TE, Biederman J, Wong J, Spencer TJ, Prince JB. Adjunctive donepezil in attention deficit hyperactivity disorder youth: case series. J Child Adolesc Psychopharmacol. 2000 Fall;10(3):217-22.
- GAL-EMR-4017