EUCTR2019-002623-14-GB进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 446
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Screening (Visit 1)
- •For inclusion in the trial, patient must fulfill ALL of the following criteria:
- •- Male or female aged 18 years or above.
- •- Willing and able to give informed consent for participation in the trial
- •- Willing and able (in the investigator's opinion) to comply with all trial requirement (With the exception of the T25FW test, if the patient is nonambulatory)
- •- Has had a diagnosis with any disease subtype of MS, by revised 2017 McDonald criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
- •- Has had treatment with at least 1 different optimized oral antispasticity therapy prior to Visit 1 that must include either oral baclofen or oral tizanidine (monotherapy or combination therapy).
- •- Currently receiving optimized treatment with at least 1 oral antispasticity medication (baclofen, tizanidine, and/or dantrolene) and has been stable for at least 30 days prior to Visit 1. Despite optimization,
- •the patient does not have adequate relief of spasticity signs and symptoms, including muscle spasms. Optimization of antispasticity medications is defined as having reached the most efficacious and best
- •tolerated dose according to the relevant local prescribing information. The patient must be willing to maintain the same antispasticity medication and not plan to initiate a new course of physiotherapy for the duration of the trial.
- •- If currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
- •-If currently receiving dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
- •- Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
- •- Willing to allow his or her primary care practitioner (if he or she has one) and/or treating neurologist (if he or she has one) to be notified of participation in the trial, if the primary care practitioner/treating
- •neurologist is different than the investigator.
- •Additional Inclusion Criteria at Randomization (Visit 2)
- •The patient is eligible for randomization in the trial if, in addition to continuing to meet the Screening (Visit 1) inclusion criteria, they also meet ALL of the following criteria during the 28-day baseline period
- •immediately prior to Visit 2:
- •- Completed at least 90% and at least 26 completed days of their electronic daily diary reporting during the baseline period.
- •- Has an average daily spasm count of = 4 during the baseline period, as recorded by the patient.
- •- Has no more than 24 spasms on any single day of the baseline period, as recorded by the patient.
- •- Does not have > 7 consecutive days without experiencing any spasm during the baseline period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 446
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The patient may not enter the trial if ANY of the following apply:
- •- Previously participated in a clinical trial of nabiximols or has had a poor previous response or intolerance to nabiximols or other cannabinoid containing products used for therapeutic purposes.
- •- Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the patient's level of spasticity.
- •-- Medical history suggests that relapse/remission is likely to occur during the trial, which, in the opinion of the investigator, is expected to influence the patient's spasticity.
- •- Has had a relapse of MS within the 60 days prior to Visit 1.
- •- Currently using or has used cannabis or a cannabinoid-derived product for medicinal or recreational use (within 30 days of Visit 1) and is unwilling to abstain for the duration of the trial.
- •- Currently using botulinum toxin injection for the relief of spasticity (within 6 months of Visit 1) and is unwilling to abstain for the duration of the trial.
- •- Currently taking antipsychotic medication.
- •- Currently taking benzodiazepines, unless the doses and dosing regimen have been stable for at least 30 days prior to Visit 1.
- •- Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
- •- Has experienced myocardial infarction or clinically significant cardiac dysfunction within the 12 months prior to Visit 1 or has a cardiac disorder that, in the opinion of the investigator, would put the patient at
- •risk of a clinically significant arrhythmia or myocardial infarction.
- •- Has a diastolic blood pressure of < 50 mmHg or > 105 mmHg or systolic blood pressure < 90 mmHg or > 160 mmHg (when measured in a sitting position at rest for 5 minutes) or a postural drop in the systolic
- •blood pressure of > 20 mmHg at Visit 1. All measurements will be performed singly and can be repeated once, if any are outside the reference range but not considered clinically significant.
- •- Has clinically significant impaired renal function at Visit 1, as evidenced by an estimated creatinine clearance lower than 50 mL/min. All measurements will be performed singly and can be repeated once, if any
- •are outside the reference range but not considered clinically significant.
- •- Has moderately impaired hepatic function at Visit 1, defined as serum alanine aminotransferase or aspartate aminotransferase > 2 × upper limit of normal. All measurements will be performed singly and can be
- •repeated once, if any are outside the reference range but not considered clinically significant.
- •- Male and fertile unless willing to ensure that he uses male contraception or remains sexually abstinent during the trial and for 3 months thereafter.
- •- Female and of childbearing potential unless willing to ensure that she uses a highly effective method of birth control during the trial and for 3 months thereafter. Patients using combined hormonal methods or a progestogen-only pill or injection or implant should use an additional barrier method such as a condom or diaphragm during the trial and for 3 months thereafter.
- •- Female and pregnant, lactating, or planning pregnancy during the course of the trial or within 3 months thereafter.
- •- Received an IMP within the 30 days prior to Visit 1.
- •- Has any other clinically significant disease or disorder that, in the opinion of the investigator, may put the patient, other patients, or site staff at risk because of participation in the trial, influence the interpretation of trial results, or may affect
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