Safety Study of Galantamine in Tic Disorders

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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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

Official Title
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Pilot Examination of Galantamine in the Management of Tic Disorders

Conditions
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Tourette's Syndrome, Motor Tic Disorder, Vocal Tic Disorder

Intervention / Treatment
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* Drug: galantamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: galantamine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse experience |  |  | 
| Severity Score of the Yale Global Tic Severity Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette's disorder, tic