Pilot Examination of Galantamine in the Management of Tic Disorders
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Treatment related adverse experience
研究概览
简要总结
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.
详细描述
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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder
- •Accepted method of birth control
排除标准
- •Preganancy or nursing
- •Unstable medical illness
- •Unstable psychiatric illness
结局指标
主要结局
Treatment related adverse experience
Severity Score of the Yale Global Tic Severity Scale
次要结局
- 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
