Table 4. Clinical studies of cannabinoids in multiple sclerosis.
Study | Product | Design | No. of Pts | “Result” | Other comment |
---|---|---|---|---|---|
Killestein, 2002 | THC vs. C. sativa extract | 20 wks, R, DB, Placebo | 16 | No change AS | Worsening in MSFC |
CAMS, Zajicek, 2003 | Marinol, Cannador | 15 wks, R, Placebo | 667 | No signif change in AS | ↓ 10 m walking time; subj imp. Spasticity, pain |
Vaney, 2004 | THC 2.5 mg CBD 0.9 mg | Pro, R, DB, placebo, X-over | 57 | No signif diff | trend in favor of ↓ spasm freq; imp. sleep, mobility |
CAMS-ext Zajicek, 2005 | Marinol, Cannador | Up to 12 mos | 502 (80% of CAMS) | Small imp AS, Marinol + Cannador | |
Wade, 2006 | Sativex | Open label, ~434 days, sub 6 wks placebo controlled | 137 | ↓ in VAS score; pain, tremor, bladder—neg | 42.3% withdrew from lack of efficacy |
Collin, 2007 | Sativex | 6 wks, DB, Placebo cont | 189 | ↓ spasticity by NRS score | No other sign effect |
Novotna, 2011 | Sativex | Unusual design: initial 4 wks single blind; Phase B: R, DB, Placebo with “early responders” | 572 phase A 241 phase B | Highly sign improvement spasticity (NRS) in phase B | Also, ↓ freq of spasms, sleep disturbances |
Notcutt, 2012 | Sativex | Blinded withdrawal in long-term treated pts | 36 (18 per group) | Time to treatment failure | Global imp of change scales (pt and caregiver) |
CBD, cannabidiol; AS, Ashworth scale (“objective” spasticity scale); MSFC, MS Functional Composite; VAS, visual analogue scale rating spasticity subjectively; NRS, subjective numerical rating scale for spasticity; wks, weeks; mos, months; pts, patients; signif, significant; diff, difference; freq, frequency; subj, subject; imp, important; neg, negative. Marinol, synthetic THC; Cannador, oral C. Sativa extract.