NCT02134080终止1 期
FAAH Inhibitor Trial for Adults With Tourette Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improvement in Tic Severity
研究概览
简要总结
The purpose of this trial is to examine the safety, tolerability and feasibility in the use of a FAAH inhibitor for the treatment of adults with Tourette syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between 18-60 years of age
- •Meet DSM IV criteria for the diagnosis of Tourette's syndrome
- •Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
- •On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.
- •Accepted method of birth control
排除标准
- •Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
- •Current use of medications that have significant effects on the cannabinoid or dopamine systems. Subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants.
- •Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
- •Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
- •Positive pregnancy test or drug screening test
- •History of cannabis dependence
- •Significant Medical Comorbidity
研究组 & 干预措施
PF-04457845
Active Comparator
PF-04457845 will be administered orally at 4mg daily for four weeks.
干预措施: PF-04457845 (Drug)
Placebo
Placebo Comparator
Placebo (sugar pill) will be administered orally at 4mg daily for four weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Tic Severity
时间窗: Evaluated each time subject seen over approximately 12 weeks
Yale Global Tic Severity Scale (Total Tic Score)
次要结局
- Improvement in Obsessive Compulsive Disorder (OCD) Severity(Evaluated every two weeks over the course of approximately 12 weeks)
- Self-Report of Tic Severity(Evaluated each time subject seen over approximately 12 weeks)
- Video-Tape Ratings of Tic Severity(Evaluated every two weeks over the course of approximately 12 weeks)
- ADHD Severity(Evaluated every two weeks over the course of approximately 12 weeks)
- Improvement of Premonitory Urges(Evaluated each time subject seen over approximately 12 Weeks)
- Depression Severity(Evaluated every two weeks over the course of approximately 12 weeks)
- Anxiety Severity(Evaluated every two weeks over the course of approximately 12 weeks)
- Overall improvement(Evaluated each time subject seen over approximately 12 Weeks)
- Number of Adverse Events(Evaluated each time subject seen over approximately 12 Weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) PatientsPurpura, Thrombotic ThrombocytopenicNCT02854059Hansa Biopharma AB2
已完成
2 期
Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's DiseaseIdiopathic Parkinson´s DiseaseNCT05931575Technical University of Munich81
进行中（未招募）
不适用
Amplatzer Amulet LAAO vs. NOACBleedingStrokeAtrial FibrillationNCT04226547Abbott Medical Devices2,650
已完成
不适用
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment MethodSubcutaneous Adipose TissueNCT01853397Solta Medical72
已完成
2 期
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's DiseaseAlzheimer Disease (AD)NCT03518073Eli Lilly and Company360