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J Neurol. 2016 Jul;263(7):1390-400. doi: 10.1007/s00415-016-8145-9. Epub 2016 May 9.

A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.

Author information

1
Neurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain. joselopezsendon@hotmail.com.
2
Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain. joselopezsendon@hotmail.com.
3
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain. joselopezsendon@hotmail.com.
4
Neurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
5
Neurobiology Department, Hospital Ramón y Cajal, Madrid, Spain.
6
Instituto de Salud Músculoesquelética, Madrid, Spain.
7
Fundación Hospital de Alcorcón, Madrid, Spain.
8
Department of Biochemistry and Molecular Biology I, Faculty of Biology, Complutense University, Madrid, Spain.
9
Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.
10
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
11
Department of Biochemistry and Molecular Biology III, Faculty of Medicine, Complutense University, Madrid, Spain.
12
Department of Organic Chemistry I, Faculty of Chemistry, Complutense University, Madrid, Spain.

Abstract

Huntington's disease (HD) is a neurodegenerative disease for which there is no curative treatment available. Given that the endocannabinoid system is involved in the pathogenesis of HD mouse models, stimulation of specific targets within this signaling system has been investigated as a promising therapeutic agent in HD. We conducted a double-blind, randomized, placebo-controlled, cross-over pilot clinical trial with Sativex(®), a botanical extract with an equimolecular combination of delta-9-tetrahydrocannabinol and cannabidiol. Both Sativex(®) and placebo were dispensed as an oral spray, to be administered up to 12 sprays/day for 12 weeks. The primary objective was safety, assessed by the absence of more severe adverse events (SAE) and no greater deterioration of motor, cognitive, behavioral and functional scales during the phase of active treatment. Secondary objectives were clinical improvement of Unified Huntington Disease Rating Scale scores. Twenty-six patients were randomized and 24 completed the trial. After ruling-out period and sequence effects, safety and tolerability were confirmed. No differences on motor (p = 0.286), cognitive (p = 0.824), behavioral (p = 1.0) and functional (p = 0.581) scores were detected during treatment with Sativex(®) as compared to placebo. No significant molecular effects were detected on the biomarker analysis. Sativex(®) is safe and well tolerated in patients with HD, with no SAE or clinical worsening. No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period. Also, no significant molecular changes were observed on the biomarkers. Future study designs should consider higher doses, longer treatment periods and/or alternative cannabinoid combinations.Clincaltrals.gov identifier: NCT01502046.

KEYWORDS:

Cannabinoid; Clinical trial; Huntington’s disease; Sativex

PMID:
27159993
DOI:
10.1007/s00415-016-8145-9
[Indexed for MEDLINE]

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