NCT00558467已完成2 期
A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 16
- 主要终点
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
研究概览
简要总结
A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male of female patients 6-17 yrs.
- •Written informed consent.
- •Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline.
- •Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children.
- •Having at least 1 tic/day.
- •Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method.
- •Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment.
- •Having a body weight of > or equal to 20 kg (44 lbs).
排除标准
- •Any women of childbearing age having a positive serum pregnancy test at screening.
- •Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening.
- •Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs.
- •Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study.
- •History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy.
- •History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood.
- •History of/or clinical signs of any malignant neoplasm.
- •Allergic response to pramipexole.
- •Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit.
- •Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit.
- •Had withdrawal symptoms of any medication at screening or at the baseline visit.
- •Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening.
- •Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline.
- •Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder.
- •Patients with severe asthma.
- •Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial.
- •Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan.
研究组 & 干预措施
Pramipexole
Other
干预措施: pramipexole immediate release (IR) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
时间窗: baseline 6 weeks
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates.
次要结局
- Clinical Global Impressions - Improvement at Week 6(baseline and Week 6)
- Clinical Global Impressions - Improvement at Week 2(baseline and Week 2)
- Clinical Global Impressions - Improvement at Week 3(baseline and Week 3)
- Clinical Global Impressions - Improvement at Week 4(baseline and Week 4)
- Clinical Global Impressions - Severity of Illness at Week 1(baseline and Week 1)
- Clinical Global Impressions - Severity of Illness at Week 2(baseline and Week 2)
- Clinical Global Impressions - Severity of Illness at Week 3(baseline and Week 3)
- Clinical Global Impressions - Severity of Illness at Week 4(baseline and Week 4)
- Clinical Global Impressions - Severity of Illness at Week 6(baseline and Week 6)
- Patient Global Impression at Week 1(baseline and Week 1)
- Patient Global Impression at Week 2(baseline and Week 2)
- Patient Global Impression at Week 3(baseline and Week 3)
- Patient Global Impression at Week 4(baseline and Week 4)
- Patient Global Impression at Week 6(baseline and Week 6)
- Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.(baseline and Week 6)
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1(baseline 1 week)
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2(baseline and 2 weeks)
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3(baseline and 3 weeks)
- Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4(baseline and 4 weeks)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6(baseline and 6 weeks)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1(baseline 1 week)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2(baseline and 2 weeks)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3(baseline and 3 weeks)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4(baseline 4 weeks)
- Clinical Global Impressions - Improvement at 1 Week(baseline and Week 1)
研究者
研究点 (16)
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