ACTRN12623000843651尚未招募2 期
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, 60-Week, Phase II Clinical Trial of Ambroxol and Doxycycline for Motor Symptoms in Moderate Severity Parkinson’s Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- •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 Queen Square Brain Bank (QSBB) criteria.
- •4. PD Modified Hoehn and Yahr stage less than or 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. Liver function tests (LFTs): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 × upper limit of normal (ULN); total bilirubin less than or equal to 1.5 × ULN; serum albumin greater than 2.8 g/dL.
- •7. Willing to avoid use of potent CYP3A4 inducers (including phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids) and potent CYP3A4 inhibitors (including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit) during the study that, in the Investigator’s judgement, are likely to impact hepatic metabolism.
- •8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (human chorionic gonadotropin [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 (IUD)
- •d. Contraceptive skin implant, eg, Implanon NXT®
- •e. Hormonal vaginal ring, eg, NuvaRing®
- •f. Documented evidence of surgical sterilisation at least 6 months prior to the Screening Visit, ie, 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.
- •9. Willing and able to have the types of diagnostic procedures required by the protocol, such as phlebotomy and other testing.
- •10. Willing and able to take oral drug therapy according to the study protocol.
- •11. Willing to practice adequate sun protection throughout the study (use of sunscreen or sun-protective clothing or limitation of sun exposure), as instructed by the Investigator or designee.
排除标准
- •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 kg/m2.
- •4. Prior surgical intervention for PD (including but not limited to deep brain stimulation [DBS], transcranial direct-current stimulation [tDCS], near infrared light [NIR] therapy, or cell transplantation) or active continuous infusion therapy (including but not limited to Duodopa® and/or apomorphine). Patients who have used the following therapies may be considered if the relevant washout period is completed:
- •a. Over the counter therapies (eg, vitamin supplements) would require a washout period of 1 month (30 days) from the Screening Visit
- •b. Other therapies where there might be a symptomatic effect (eg, red light therapy, tDCS) would require a washout period of a minimum of 12 weeks from the Screening Visit
- •c. Previous disease-modifying or systematic IPs would require a washout period of at least five times the half-life of the treatment.
- •Therapeutic use of cannabidiol is permitted if not part of a clinical trial.
- •5. History of psychotic symptoms requiring antipsychotic treatment or exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to Screening.
- •6. History of suicide attempt(s) within the 6 months prior to Screening.
- •7. Gastrointestinal conditions that may affect the absorption of IP (eg, ulcerative colitis, gastric bypass).
- •8. Diagnosis of insulin-dependent Type 1 diabetes mellitus (T1DM).
- •9. History of significant medical event(s) within 6 months prior to the Screening Visit, at the discretion of the Investigator. This includes, but is not limited to, a cerebrovascular event or a myocardial infarction.
- •10. Serious neurological disorder other than PD.
- •11. History of head trauma with loss of consciousness for more than 5 minutes within the past 6 months.
- •12. Sustained supine hypertension greater than or 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.
- •13. History of symptomatic orthostatic hypotension (OH) which interferes with the patient’s day-to-day level of functioning. OH is defined as a decrease of greater than or equal 20 mmHg systolic or greater than or equal 10 mmHg diastolic when changing from supine to standing position, after having been in supine position for at least 5 minutes.
- •14. Any significant uncontrolled cardiac arrhythmia, including but not limited to second and third degree atrioventricular (AV) block.
- •15. Current unstable angina.
- •16. Congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
- •17. Heart rate less than 50 bpm as tested on three occasions, 10 minutes apart.
- •18. Abnormal 12-lead electrocardiogram (ECG) results which, in the opinion of the Investigator, will prevent participation in the study.
- •19. Prior difficulties with swallowing solid oral IPs.
- •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
研究者
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