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. 2022 May 5;2022(5):CD013444. doi: 10.1002/14651858.CD013444.pub2

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
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
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