NCT06490445已完成2 期
A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain
Syqe Medical76 个研究点 分布在 5 个国家目标入组 122 人开始时间: 2024年11月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 76
- 主要终点
- Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and efficacy of medical cannabis aerosol containing 0.25, 0.50, 1.0 milligrams (mg) delta (Δ) 9-tetrahydrocannabinol (THC) inhaled three times a day (TID) compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15.
详细描述
This study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of medical cannabis aerosol inhaled via the Syqe Inhaler at nominal doses of 0 (placebo), 0.25, 0.5, and 1.0 mg TID of Δ9-THC added on to standard of care for treatment of DPNP.
The target sample size is 192 eligible participants worldwide, randomized from up to approximately 51 recruiting sites in up to approximately 8 countries.
The study consists of 1) a screening period of up to 14 days; 2) a 15-week, parallel-group, randomized, double-blind treatment period, including a 3-week up-titration period and a 12-week maintenance period; and 3) a post-treatment, safety follow-up period of 4 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions.
- •Males and females aged between 18 (included) and 75 (included) years.
- •Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products.
- •Agree not to participate in other interventional clinical studies during participation in this study.
- •Treated with standard of care for DPNP, defined as either duloxetine, gabapentin or pregabalin as monotherapy or a combination of 2, or participants who discontinued the use of standard of care, or amitriptyline used for the management of pain related to DPNP, at least 3 months prior to screening.
- •Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.
- •Glycated hemoglobin (HbA1c) less than or equal to (<=) 10% at screening.
- •Body mass index between 18 and 40 kilograms per square meter (kg/m^2), inclusive.
- •Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization.
- •Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the administration of study treatment on Day 1or be of non-child-bearing potential as defined in the protocol.
- •Participants of reproductive potential who are sexually active must use highly effective birth control methods.
排除标准
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol at screening or randomization, ability to complete the study, or study assessments.
- •Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
- •Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
- •Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.
- •Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- •Liver disease or liver injury as indicated by abnormal liver function tests at screening.
- •History or presence of impaired renal function at screening
- •Presence of significant pulmonary disease at screening
- •Ongoing respiratory infection.
- •History of acute coronary syndrome in the last 12 months; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure.
- •Concomitant clinically significant cardiac arrhythmias, examples, sustained ventricular tachycardia, and second or third degree atrioventricular block without a pacemaker, or any other relevant cardiac disease in the judgment of the investigator.
- •History of clinically significant electrocardiograms (ECG) abnormalities, or any of the following ECG abnormalities at screening or baseline:
- •PR greater than (>) 200 milliseconds (msec)
- •QRS complex >120 msec
- •Fridericia QT correction formula (QTcF) greater than (>) 450 msec
- •History of familial long QT syndrome or known family history of ventricular arrythmia.
- •Acute ischemic changes.
- •History or presence of mental illness evidenced as defined in the protocol.
- •Abnormal neurological condition or abnormal neurological examination other than related to DPN as judged by the investigator at screening that impacts the assessment of study endpoints.
研究组 & 干预措施
1.0 mg THC
Experimental
Participants will inhale medical cannabis aerosol containing 1.0 mg THC via the Fixed-dose Syqe Inhaler three times a day.
干预措施: Medical Cannabis (Drug)
0.25 mg THC
Experimental
Participants will inhale medical cannabis aerosol containing 0.25 mg THC via the Fixed-dose Syqe Inhaler three times a day.
干预措施: Medical Cannabis (Drug)
0.5 mg THC
Experimental
Participants will inhale medical cannabis aerosol containing 0.5 mg THC via the Fixed-dose Syqe Inhaler three times a day.
干预措施: Medical Cannabis (Drug)
Placebo
Placebo Comparator
Participants will receive placebo, inhaled TID via the Fixed-dose Syqe Inhaler.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15
时间窗: Baseline and at Week 15
The NRS is an 11-point scale with scores ranging from 0 (no pain) to 10 (worst pain imaginable) for measuring participant self-reporting of pain intensity. A reduction in the score over time represents an improvement.
次要结局
- Number of Participants With Clinically Significant Abnormal Lung Function Measured using Spirometry(Baseline up to Week 19)
- Number of Participants With Clinically Significant Abnormality in Blood and Urine Parameters(Baseline up to Week 19)
- Pharmacokinetics - Cmax,ss(At selected visits from baseline up to Week 16)
- Assessment of Withdrawal Symptoms After Termination of Study Treatment using the Study Medication Withdrawal Questionnaire Version 2 (SMWQ V2)(Baseline up to Week 19)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI)(Baseline up to Week 19)
- Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Scale(Baseline up to Week 19)
- Change From Baseline in Weekly-mean 24-hour Average, Worst and Least Pain Score on the NRS(Baseline up to Week 19)
- Proportion of Participants With Adverse Events (AEs) Leading to Study Treatment Discontinuation and Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs).(Baseline up to Week 19)
- Assessment of Diabetic Neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) - Part B(Baseline up to Week 19)
- Proportion of Participants Achieving at least 30 Percent (%) and 50% Reduction From Baseline in the Weekly-mean 24-hour Average Pain Score on the NRS(Baseline up to Week 19)
- Proportion of Participants with Treatment-emergent Adverse Events (TEAEs) and Their Severity(Baseline up to Week 19)
- Assessment of Suicidal Ideation and Behavior using the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline up to Week 19)
- Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)(Baseline up to Week 19)
- Pharmacokinetics - Ctrough(At selected visits from baseline up to Week 16)
- Pharmacokinetics - Tmax,ss(At selected visits from baseline up to Week 16)
- Pharmacokinetics - AUC(At selected visits from baseline up to Week 16)
- Proportion of Participants who Need Rescue Medication for the Treatment of DPNP(Baseline up to Week 19)
- Amount of Rescue Medication Taken for the Treatment of DPNP(Baseline up to Week 19)
- Change From Baseline in Weekly-mean 24-hour Sleep Score Using the Daily Sleep Interference Scale (DSIS)(Baseline up to Week 19)
- Time to First Intake of Rescue Medication Taken for the Treatment of DPNP(Baseline up to Week 19)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile Total Score(Baseline up to Week 19)
- Frequency of Rescue Medication Taken for the Treatment of DPNP(Baseline up to Week 19)
- Change From Baseline in Sleep Score Using the Pain and Sleep Questionnaire-3 (PSQ-3)(Baseline up to Week 19)
研究者
研究点 (76)
Loading locations...
相似试验
已完成
1 期
Medicinal Cannabis for Painful HIV NeuropathyNeuropathic PainNCT00255580Center for Medicinal Cannabis Research28
已完成
2 期
Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress DisorderPosttraumatic Stress DisorderNCT02517424Tilray6
已完成
3 期
Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MSMultiple SclerosisNCT00391079GW Pharmaceuticals Ltd339
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B VaccineHepatitis B, ChronicNCT04289987CHA Vaccine Institute Co., Ltd.134
进行中（未招募）
3 期
Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone DiseaseAmyotrophic Lateral SclerosisMotor Neuron DiseaseNCT03690791Gold Coast Hospital and Health Service17