EUCTR2019-002623-14-CZ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
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 non-ambulatory)
- •- 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 MS antispasticity therapies prior to Visit 1 that must include at least oral baclofen or oral tizanidine (monotherapy or combination therapy).
- •- Currently receiving optimized treatment with at least 1 oral antispasticity medication (baclofen, tizanidine 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 and 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 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 first 28-days of the baseline
- •period (Note: patients are expected to start completing their electronic
- •diary in the evening of their screening visit):
- •- In the opinion of the investigator the patient is able to interpret and
- •report spasm count data accurately
- •- Completed their electronic diary for at least 25 of the first 28 days of
- •the baseline period
- •- Has an average daily spasm count of = 4 during the first 28 days of the
- •baseline period, as recorded by the patient.
- •- Has no more than 35 spasms on any single day of the first 28 days of
- •the baseline period, as recorded by the patient
- •- Does not have > 7 consecutive days without experiencing any spasm
- •during the first 28 days of the baseline period.
- •If, for any reason, the patient is unable to attend the site for
- •randomization within the visit window, the site should contact the
- •Medical Monitor or the sponsor to discuss. In addition to meeting the
- •Screening (Visit 1) inclusion criteria and additional inclusion criteria
- •above (apart from last bullet point), any patient with more than 28 days
排除标准
- •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 is expected to influence the patient’s spasticity
- •- Has had a relapse of MS within the 60 days prior to Visit 1
- •- Has taken cannabis, or a cannabis-derived product for medicinal or recreational use within the 30 days prior to screening or a positive blood drug test for THC at screening
- •- Is unwilling to abstain from use of cannabis or a cannabis-derived product for medicinal or recreational purposes for the duration of the trial
- •- Currently using botulinum toxin injection for the relief of spasticity
- •- Is unwilling to abstain from the use of botulinum toxin injection for the relief of spasticity 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 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 > 150 mmHg, or a postural drop in the systolic blood pressure of > or = 20 mmHg or in diastolic blood pressure of > or = 10 mmHg at Visit 1
- •- Has clinically significant impaired renal function at Visit 1 as evidenced by an estimated creatinine clearance lower than 50 mL/min
- •- Has moderately impaired hepatic function at Visit 1 defined as serum alanine aminotransferase or aspartate aminotransferase >2 × upper limit of normal
- •- 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 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 the patient’s ability to take part in the trial
- •- Has any abnormalities identified following a physical examination, clinical laboratory, serology, or other applicable screen procedures that would jeopardize the safety of the patient or the conduct of the study if he or she took part in the trial
- •- Has any history of suicidal behavior in the 5 years prior to Visit 1 or a suicidal ideation score of 3, 4, or 5 on the C-SSRS in the month prior to Visit 1
- •- Has a history of severe psych
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