Safety & Adverse Effects
Study register · detail RCT (doppelblind, Placebo-kontrolliert, Cross-over) · Safety & Adverse Effects · 2009

A pilot study using nabilone for symptomatic treatment in Huntington's disease.

Mixed GRADE Moderate 157 citations
Samplen = 44 Pat.
Durationunclear
ControlPlacebo
EndpointUHDRS total motor score
Blindingdoppelblind
DesignRCT (doppelblind, Placebo-kontrolliert, Cross-over)
Cannabinoidthc
Max. dose2.0 mg
Routeoral
Key finding

Nabilone improved chorea and neuropsychiatric symptoms, but not the total motor score, compared with placebo.

Summary

n=44 Huntington's disease patients (nabilone 1–2 mg vs. placebo, cross-over); nabilone safe and well tolerated, no psychotic episodes; treatment difference in UHDRS total motor score 0,86 (95% CI: −1,8 to 3,52); chorea score difference 1,68 (95% CI: 0,44 to 2,92). No serious adverse event documented.

P
PopulationAdults with Huntington's disease, n=44
I
InterventionNabilone 1 or 2 mg oral (cross-over)
C
ControlPlacebo
O
OutcomeUHDRS total motor score: treatment difference 0,86 (95% CI: −1,8 to 3,52, n.s.); chorea score: 1,68 (95% CI: 0,44 to 2,92); NPI: 6,43 (95% CI: 0,2 to 12,66)
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Mixed
Citations / year
Authors
Curtis A, Mitchell I, Patel S, Ives N, Rickards H.
DOI 10.1002/mds.22809
Design: RCT (doppelblind, Placebo-kontrolliert, Cross-over)
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Abstract
Pilot study of nabilone in Huntington's disease (HD). Double-blind, placebo-controlled, cross-over study of nabilone versus placebo. Primary outcome, Unified Huntington's Disease Rating Scale (UHDRS) total motor score. Secondary measures: UHDRS subsections for chorea, cognition and behavior, and neuropsychiatric inventory (NPI). 44 randomized patients received either nabilone (1 or 2 mg) followed by placebo (n = 22), or placebo followed by nabilone (n = 22). Recruiting was straightforward. Nabilone safe and well tolerated, no psychotic episodes. Assessment of either dose of nabilone versus placebo showed a treatment difference of 0.86 (95% CI: -1.8 to 3.52) for total motor score; 1.68 (95% CI: 0.44 to 2.92) for chorea; 3.57 (95% CI: -3.41 to 10.55) for UHDRS cognition; 4.01 (95% CI: -0.11 to 8.13) for UHDRS behavior, and 6.43 (95% CI: 0.2 to 12.66) for the NPI. Larger longer RCT of nabilone in HD is feasible and warranted.

The impediment to action advances action. — Marcus Aurelius