A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 60
- 主要终点
- Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
研究概览
简要总结
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
详细描述
A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo.
Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.
Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.
During the titration phase:
The following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
- •Diagnosed with idiopathic PD.
- •LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
- •If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
- •Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
- •Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
排除标准
- •Pregnant or breastfeeding.
- •Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
- •Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
- •Use of nonselective MAO inhibitors.
- •Use of dopamine agonists within 30 days prior to Screening.
- •Unable to tolerate a placebo regimen, in the Investigator's opinion.
- •Treatment of psychosis with any antipsychotic.
- •History of seizure or epilepsy.
- •Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
- •History of narrow-angle glaucoma.
- •Subjects with a history of malignant melanoma.
- •History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
- •Received any investigational medications during the 30 days prior to Screening.
研究组 & 干预措施
Placebo
One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).
干预措施: Placebo (Drug)
IPX066 145 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: Placebo (Drug)
IPX066 145 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 95 mg LD (Drug)
IPX066 145 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 145 mg LD (Drug)
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: Placebo (Drug)
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 95 mg LD (Drug)
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 145 mg LD (Drug)
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 195 mg LD (Drug)
IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
干预措施: IPX066 245 mg LD (Drug)
IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
干预措施: IPX066 95 mg LD (Drug)
IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
干预措施: IPX066 145 mg LD (Drug)
IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
干预措施: IPX066 195 mg LD (Drug)
IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
干预措施: IPX066 245 mg LD (Drug)
结局指标
主要结局
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
时间窗: Week 30
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study). Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
次要结局
- Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score(Baseline and Week 30 (or End of Study))