Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226824
Status:
TERMINATED
Last Update Posted:
2009-08-25
First Post:
2005-09-23
Brief Title:
Safety Study of Galantamine in Tic Disorders
Sponsor:
Parkinsons Disease and Movement Disorders Center
Organization:
Parkinsons Disease and Movement Disorders Center
Study Overview
Official Title:
Pilot Examination of Galantamine in the Management of Tic Disorders
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit subjects into the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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12 mg bid after 8 weeks They will maintain at 12 mg bid or the maximum tolerated dose for a further 8 weeks and then be withdrawn from therapy The difference in tic severity prior to and upon completion of therapy will be examined The impact of treatment upon obsessionscompulsions attentionconcentration depression anxiety and quality of life will also be determined
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 obsessionscompulsions attentionconcentration depression anxiety and quality of life will also be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None