Safety Study of Galantamine in Tic Disorders
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|ClinicalTrials.gov Identifier: NCT00226824|
Recruitment Status : Terminated (Unable to recruit subjects into the trial.)
First Posted : September 27, 2005
Last Update Posted : August 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Syndrome Motor Tic Disorder Vocal Tic Disorder||Drug: galantamine||Phase 4|
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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Examination of Galantamine in the Management of Tic Disorders|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||May 2007|
- Treatment related adverse experience
- Severity Score of the Yale Global Tic Severity Scale
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226824
|United States, New York|
|Parkinson's Disease and Movement Disorders Center of Albany Medical Center|
|Albany, New York, United States, 12205|
|Principal Investigator:||Donald S Higgins, M.D.||Parkinson's Disease and Movement Disorder Center of Albany Medical Center|