ACTRN12620000560998招募中2 期
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, 60-Week, Phase II Clinical Trial on the effect of Three Re-Purposed Medications on Moderate Severity Parkinson’s Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •1. Ability to provide written informed consent in accordance with GCP, ICH, and local regulations
- •2. Male or female aged 25 to 80 (inclusive) as of the date of baseline visit
- •3. Diagnosis of idiopathic PD according to QSBB criteria
- •4. PD Modified Hoehn and Yahr stage equal to 2.5 in the ON” usual PD medication state
- •5. Must be stabilised on optimal dopaminergic PD treatment for a minimum of
- •4 weeks prior to the screening visit with no changes in dosing or PD medication expected throughout the study
- •6. (LFTs: ALT and AST less than or equal to 3 × ULN; total bilirubin less than or equal to 1.5 × ULN; serum albumin greater than or equal to 2.8 g/dL
- •7. (WOCBP must have a negative serum pregnancy test hCG at screening. WOCBP and men must agree to use highly effective, double barrier contraception during the study. Double barrier contraception is defined as a condom and one other form of the following:
- •a. Contraceptive pill
- •b. Depot or injectable birth control
- •c. Intrauterine Device
- •d. Contraceptive skin implant, e.g. Implanon NXT®
- •e. Hormonal vaginal ring, e.g., NuvaRing®
- •f. Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. Must be willing to remain on their current form of contraception for the duration of the study.
- •8. Willing and able to have the types of diagnostic procedures required by the protocol, such as phlebotomy and other testing
- •9. Willing and able to take oral drug therapy according to the study protocol
排除标准
- •Exclusion Criteria
- •1. Confirmed or suspected atypical or parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, cerebrovascular disease or neurodegenerative diseases
- •2. Females who are pregnant or breastfeeding
- •3. Body mass index less than 18.5
- •4. Prior surgical intervention for PD (including but not limited to DBS, tDCS,
- •NIr therapy or cell transplantation) or active continuous infusion therapy
- •(including but not limited to Duodopa® and/or apomorphine)
- •5. Any known hypersensitivity to any of the three IPs or their constituents
- •6. Received any of the following drugs within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer:
- •a. Any of the three IPs
- •b. Any asthma medication/s which have ß2 adrenergic agonist action (e.g., budesonide with formoterol)
- •c. CCB medication
- •d. ß-blocker medication
- •e. Prochlorperazine
- •f. Metoclopramide hydrochloride
- •h. Oral or sublingual supplements which may contain nicotinamide,
- •including but not limited to:
- •i. nicotinamide tablets
- •ii. niacinamide tablets
- •iii. vitamin B3 tablets
- •iv. vitamin B complex
- •v. any NAD+ potential booster
- •vi. any other over the counter medication which may interfere with the outcomes of the study
- •7. Exposed to typical or atypical antipsychotics or other dopamine blocking agents
- •within 6 months prior to screening
- •8. Gastrointestinal conditions that may affect the absorption of IP (e.g. ulcerative colitis, gastric bypass)
- •9. Diagnosis of T1DM or T2DM, for which drug treatment is prescribed 10. History of significant medical event/s within 6 months prior to the screening visit, at the discretion of the PI. This includes, but is not limited to a cerebrovascular event or a myocardial infarction
- •11. Serious neurological disorder other than PD
- •12. History of head trauma with loss of consciousness for more than 5 minutes within the past 6 months
- •13. Sustained supine hypertension equal to 180 mmHg systolic or 110 mmHg diastolic;
- •sustained is defined as the average of three observations, each at least 10 minutes apart, with the patient having been supine and at rest for at least 5 minutes prior to each measurement
- •14. History of symptomatic OH which interferes with the patient’s day-to-day level of functioning. OH is defined as a decrease of greater than or equal to 20 mmHg systolic or
- •greater than or equal to 10 mmHg diastolic when changing from supine to standing position, after having been in supine position for at least 5 minutes
- •15. Any significant uncontrolled cardiac arrhythmia, including but not limited to second and third degree AV block
- •16. Current unstable angina
- •17. Congestive heart failure (NYHA Class 3 or 4)
- •18. Heart rate lesser than or equal to 50 bpm as tested on three occasions 10 minutes apart
- •19. Abnormal 12-lead ECG results which, in the opinion of the Investigator, will prevent participation in the study
- •20. Prior diagnosis of cancer and evidence of continued malignancy within the past 3 years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or in situ prostate cancer with normal prostate-specific antigens post resection)
- •21. Any major surgical procedure within 30 days prior to the screening visit
- •22. Severely impaired renal function with creatinine clearance less than 30 mL/min
- •23. Diagnosis of dementia as defined by MDS PD Dementia criteria
- •24. Active alcohol or substance use disorder within the past 12 months
研究者
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