Motor Tic Disorder, Tourette's Syndrome, Vocal Tic Disorder
Conditions
Keywords
Tourette's disorder, tic
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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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.
Interventions
DRUGgalantamine
Sponsors
Ortho-McNeil Neurologics, Inc.
Parkinson's Disease and Movement Disorders Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment related adverse experience | — |
| Severity Score of the Yale Global Tic Severity Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression | — |
| Yale-Brown Obsessive-Compulsive Survey | — |
| Short Form 36 | — |
| Hamilton Rating Scale for Anxiety | — |
| Connors Adult Attention Deficit Hyperactivity Rating Scale | — |
Countries
United States
Outcome results
None listed