A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis
- Conditions
- Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-002625-29-GB
- Lead Sponsor
- GW Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 52
For inclusion in the trial, patients 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 requirements.
• 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 an MAS untransformed score of at least 2 in 2 or more of 6 muscle groups (right knee flexors, left knee flexors, right knee extensors, left knee extensors, right plantar flexors, or left plantar flexors) at Visit 1.
• Currently receiving optimized treatment with at least 1 oral antispasticity drug (baclofen, tizanidine, and/or dantrolene) that has been stable for at least 30 days prior to Visit 1. Despite optimization, the patient does not have adequate relief of spasticity 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 be 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 from the investigator.
Additional Inclusion Criteria at Randomization (Visit 2)
Patients are eligible for randomization in the trial if, in addition to
continuing to meet the Screening (Visit 1) inclusion criteria, they also
meet the following criterion prior to Visit 2 (Day 1):
• Completed at least 5 of 7 days of their electronic diary reporting during
the 7 days immediately preceding Visit 2 (Day 1).
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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
The patient may not enter the trial if:
•Has taken nabiximols, cannabis, or a cannabis-derived product for medicinal or recreational purposes in the 30 days prior to Visit 1 and unable to abstain for the duration of the study
•Did not tolerate or did not respond adequately to treatment with nabiximols or another cannabis-based medication if exposed at any time before the 30-day period prior to Visit 1
•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 pt's spasticity
•Has had a relapse of MS within the 60 days prior to Visit 1
•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 doses and dosing regimen
have been stable for at least 30 days prior to Visit 1
•Clinically suspected to have a contracture in one of the muscle groups of the lower limbs, preventing assessment with the MAS
•Has any known/suspected hypersensitivity to cannabinoids or any of the excipients of the IMP
•Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 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 (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 or Visit 2
•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 (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN)
•Male and fertile (i.e., after puberty unless permanently sterile by bilateral orchiectomy) unless willing to ensure that he uses male contraception (condom or vasectomy) or remains sexually abstinent during the trial and for 3 months thereafter
•Female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for = 12 consecutive months unless permanently
sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) 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 (positive pregnancy test at Visit 1 or Visit 2), lactating, or planning pregnancy during the course of the trial or within 3 months thereafter
•Has received an IMP within the 30 days prior to Visit 1
•Has any other clinically significant disease or disorder (including
seizure 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, may
influence the interpretation of trial results, or may affect the patient's
ability to take part in the trial
•Has any abno
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method