Randomized Study of Pergolide in Children With Tourette Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
研究概览
简要总结
OBJECTIVES:
I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome (GTS).
II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics.
III. Determine efficacy of pergolide for tic control in these patients.
详细描述
PROTOCOL OUTLINE:
This is a three part study: part I is a randomized, double blind, fixed single dose study; part II is a randomized, open label, stratified study; and part III is a randomized, double blind, placebo controlled study.
Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. Part II patients are randomized to receive either low or high dose pergolide for 4 weeks.
Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. Total treatment duration is 16 weeks.
Patients are followed at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •DSM IV primary diagnosis of Tourette syndrome (GTS) Multiple Axis I and Axis II diagnoses allowed
- •Tourette symptom severity great enough to warrant medication (CGI severity index at least 4)
- •No chronic motor tic disorder or transient tic disorder, anorexia nervosa, pervasive developmental disorders, substance/alcohol abuse or dependence within the past year, schizophrenia or any psychotic disorder
- •-Prior/Concurrent Therapy--
- •At least 4 weeks since prior neuroleptic therapy
- •At least 2 weeks since all other prior medications
- •No concurrent neuroleptic therapy or psychotropic therapy (i.e., antidepressant or anticholinergic)
- •No concurrent medication that may alter or interact with pergolide
- •-Patient Characteristics--
- •Performance status: Outpatient status
- •Hematopoietic: Normal or clinically insignificant values
- •Hepatic: Normal or clinically insignificant values
- •Renal: Normal or clinically insignificant values
- •Cardiovascular: Normal electrocardiogram
- •Other: No serious or unstable medical illness (i.e., diabetes, seizure disorder); Must be able to perform required measurements (i.e., no low I.Q.); Effective contraception required by all fertile patients
排除标准
- 未提供