Fox 2004.
Study characteristics | ||
Methods | Design: Randomised cross‐over study Setting: UK; two centres Recruitment: 3 May to 31 May 2002 Number screened: 27 Number randomised: 14 Outcome timing: 2 weeks | |
Participants |
Tremor in MS Inclusion criteria: diagnosis of definite MS (Poser 1983), age between 18 and 64 years, and a visible upper limb tremor Exclusion criteria: cognitive impairment; history of ischaemic heart disease or psychotic illness, or unwilling to stop driving for the period of the study Randomised: N = 14; % female: 57.1; mean age: 45 (range: 35 to 56) years; mean EDSS: 6.25 (range: 3.5 to 7.5); previous cannabis use: 1 participant |
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Interventions |
Cannador versus placebo. Cannador is an ethanolic extract of cannabis sativa standardised to 2.5 mg of THC per capsule. Identical placebo capsule. In a titration phase the dose was escalated at 3‐day intervals until either the patient reached a maximum dose of 0.125 mg/kg of THC twice a day or they began to experience intolerable side effects, in which case the dose was dropped to the last tolerated dose.
Study duration: 2 x2 weeks treatment periods. No washout Concomitant medication during the study: NR |
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Outcomes | Tremor: change on a tremor index, measured using a validated tremor rating scale Spasticity: not assessed Pain: not assessed PGIC: not assed HRQoL: not assessed Serious AEs: NR AEs: N/phase Dizziness: N/phase Somnolence: N/phase | |
Notes | Funding: public. One author was funded by a grant from the Medical Research Council |