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Safety Study of Galantamine in Tic Disorders

Primary Purpose

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

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
galantamine
Sponsored by
Parkinson's Disease and Movement Disorders Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Syndrome focused on measuring Tourette's disorder, tic

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkinson's Disease and Movement Disorders Center of Albany Medical Center

Outcomes

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

Full Information

First Posted
September 23, 2005
Last Updated
August 21, 2009
Sponsor
Parkinson's Disease and Movement Disorders Center
Collaborators
Ortho-McNeil Neurologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00226824
Brief Title
Safety Study of Galantamine in Tic Disorders
Official Title
Pilot Examination of Galantamine in the Management of Tic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit subjects into the trial.
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Parkinson's Disease and Movement Disorders Center
Collaborators
Ortho-McNeil Neurologics, Inc.

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome, Motor Tic Disorder, Vocal Tic Disorder
Keywords
Tourette's disorder, tic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
galantamine
Primary Outcome Measure Information:
Title
Treatment related adverse experience
Title
Severity Score of the Yale Global Tic Severity Scale
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Survey
Title
Connors Adult Attention Deficit Hyperactivity Rating Scale
Title
Hamilton Rating Scale for Depression
Title
Hamilton Rating Scale for Anxiety
Title
Short Form 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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: Preganancy or nursing Unstable medical illness Unstable psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald S Higgins, M.D.
Organizational Affiliation
Parkinson's Disease and Movement Disorder Center of Albany Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkinson's Disease and Movement Disorders Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10440471
Citation
Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2. doi: 10.1097/00004714-199908000-00019. No abstract available.
Results Reference
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PubMed Identifier
11052411
Citation
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. doi: 10.1089/10445460050167322.
Results Reference
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PubMed Identifier
14643839
Citation
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. doi: 10.1016/j.pbb.2003.08.015.
Results Reference
background
PubMed Identifier
11122998
Citation
Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. doi: 10.1007/s11920-000-0005-7.
Results Reference
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Links:
URL
http://www.amc.edu/Patient/services/neurosciences/clinical_specialties/movement_disorders/parkinsonism.html
Description
Parkinson's Disease and Movement Disorders Center of Albany Medical Center

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Safety Study of Galantamine in Tic Disorders

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