Collin 2010.
| Study characteristics | ||
| Methods | Design: parallel group RCT Setting: multicentre, 15 centres in the UK and 8 centres in Czech Republic Recruitment: NR Number screened: 388 Number randomised: 337 Outcome timing: 14 weeks | |
| Participants |
Spasticity in MS Inclusion criteria: any MS subtype; ≥6 months duration; ≥ 3 month history of spasticity due to MS not wholly relieved with current therapy; mean daily score of ≥4 on spasticity NRS (moderate spasticity) during the last 6 days of the baseline period; stable anti‐spasticity regimen ≥ 30 days preceding study entry Exclusion criteria: spasticity not due to MS; concurrent history of significant psychiatric, renal, hepatic, cardiovascular or convulsive disorders Treatment group (Nabiximols/Sativex): N = 167; % female: 63.0; mean age: 48.0 (SD 10.06) years; mean EDSS: 6.0 (SD 1.56); mean duration of MS: 14.4 (SD 8.29) years; % previous cannabis use: 20; mean duration of spasticity: 7.5 (SD 5.14) years Placebo group: N = 170; % female: 59.0; mean age: 47.1 (SD 9.15) years; mean EDSS: 6.0 (SD 1.50); mean duration of MS: 16.0 (SD 8.48) years; % previous cannabis use: 28; mean duration of spasticity: 8.0 (SD 5.51) years |
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| Interventions | Sativex: oromucosal spray: 100 µl containing 2.7 mg of delta‐9‐THC and 2.5 mg of CBD Placebo: oromucosal spray containing peppermint oil flavouring, 0.05%(v/v); quinoline yellow, 0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in ethanol:propylene glycol (50:50) excipients Dose frequency: maximum 24 sprays in any 24 hour period. Daily number of sprays taken during the study: Sativex: mean 8.5 (range: 1–22); Placebo: mean 15.4 (range: 2– 23) Concomitant medication during the study: % Baclofen: Sativex 79; Placebo 81. % Tizanidine: Sativex 41; Placebo 45. % Benzodiazepines: Sativex 26; Placebo 30. % Gabapentin: Sativex 16; Placebo 15. % Dantrolene: Sativex 8; Placebo 6. % Other: Sativex 62; Placebo 59. % No previous or concomitant anti‐spasticity medications: Sativex 4; Placebo 2 | |
| Outcomes |
Spasticity
Pain. Measure: NRS 0‐10. Data: number of participant reporting ≥ 50% improvement not reported. Mean change from baseline without SD reported. Mean treatment difference (P value) reported Withdrawal due to AE: N/group PGIC much or very much improved: not assessed HRQoL
Serious AEs: N/group AEs: N/group Nervous system disorders‐related AE: N/group Psychiatric disorders‐related AE: N/group Dizziness: N/group Somnolence: N/group Headache: N/group Confusion‐ disorientation: N/group Paranoia: N/group Psychosis: NR Hallucinations: NR Drug tolerance: N/group Urinary incontinence: not assessed Muscle spasms severity. Measure: NRS 0‐10. Data: mean change from baseline without SD. Mean treatment difference (P value) Fatigue. Measure: NRS 0‐10. Data: mean change from baseline without SD. Mean treatment difference (P value) Sleep quality. Measure: NRS 0‐10 sleep quality. Data: mean change (SD) from baseline reported. Mean treatment difference (95% CI and P value) reported Mobility/ADLs. Measure: Barthel ADL index score. Data: mean change (SD) from baseline reported. Mean treatment difference (95% CI and P value) reported Anxiety: not assessed Depression: not assessed CGIC much or very much improved. Measure: 7‐point Likert‐type scale with the markers "very much improved, much improved, lightly improved, no change, slightly worse, much worse or very much worse. Data: number of participants reporting "very much improved" or "much improved" reported (OR, 95% CI and p value) Reduced use of anti spastics: not assessed Reduced use of analgesics: not assessed |
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| Notes | Funding: industry ‐ drug manufacturer | |