A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A
- Conditions
- Spasticity due to Multiple Sclerosis (MS)
- Registration Number
- EUCTR2004-002509-63-CZ
- Lead Sponsor
- GW Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 284
1. Subject is willing and able to give informed consent for participation in the study
2. Aged 18 years or above
3. Subject is able (in the investigators opinion) and willing to comply with all study requirements
4. Diagnosed with any disease sub-type of MS of duration of greater than 6 months
5. Diagnosed with spasticity due to MS of at least 3 months duration and whose spasticity is not wholly relieved with their current therapy
6. If receiving disease modifying medications, these be at a stable dose for at least six months duration prior to the screening visit and willing to maintain this for the duration of the study
7. If receiving regular anti-spasticity and non-pharmacological therapies, these be at a stable dose for at least 30 days prior to the screening visit and willing for these to be maintained throughout the study
8. The last 6 daily spasticity NRS scores before randomisation (B2 to B7) have been completed and to sum at least 24
9. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
10. Willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any concomitant disease or disorder that has symptoms of spasticity, or that may influence the subject's level of spasticity
2. Currently receiving Botulinum Toxin injections and unwilling to stop for the duration of the study, or has received Botulinum Toxin injection within 4 months prior to the screening visit
3. Currently using or has used cannabis within 30 days of study entry and unwilling to abstain for the duration of the study
4. Currently using or has used cannabinoid based medications within 60 days of study entry and unwilling to abstain for the durationof the study
5. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
6. Any known history of alcohol or substance abuse
7. Any history of epilepsy or recurrent seizures
8. Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications
9. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
10. Subject has a QT interval > 450 ms (males) or > 470 ms (females) as reviewed at the screening visit
11. Subject has a secondary tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (>110 bpm) as reviewed at the screening visit
12. Subject has a diastolic blood pressure of < 50 mmHg or > 105 mmHg as reviewed prior to randomisation
13. Subject has impaired renal function i.e. serum creatinine clearance is lower than 50ml/min at the screening visit
14. Subject has significantly impaired hepatic function in the opinion of the investigator and/or has liver function test values equal to or greater than three times the upper limit of normal
15. Following a physical examination has the subject any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
16. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure they or their partner use contraception during the study and for 3 months thereafter
17. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months thereafter
18. Subjects who have received an Investigational Medicinal Product within the 12 weeks before the screening visit
19. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study
20. Travel outside the country of residence planned during the study
21. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
22. Unwilling to abstain from donation of blood during the study
23. Subjects previously randomised into this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Sativex compared with placebo in relieving symptoms of spasticity due to MS;Secondary Objective: To evaluate the effect of Sativex compared to placebo on;<br>- secondary measures of spasticity<br>- functional measures<br>- quality of life<br>- proportion of patients showing an improvement of 30% or more and 50% or more in their primary endpoint from baseline to end of study<br>To assess the safety and tolerability of Sativex.;Primary end point(s): Mean spasticity during weeks 13 and 14 using an 11-point numerical rating scale (NRS) spasticity score taken from daily diaries
- Secondary Outcome Measures
Name Time Method