Abstract Title:

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

Abstract Source:

J Neurol. 2016 May 9. Epub 2016 May 9. PMID: 27159993

Abstract Author(s):

Jose Luis López-Sendón Moreno, Juan García Caldentey, Patricia Trigo Cubillo, Carolina Ruiz Romero, Guillermo García Ribas, M A Alonso Alonso Arias, María Jesús García de Yébenes, Rosa María Tolón, Ismael Galve-Roperh, Onintza Sagredo, Sara Valdeolivas, Eva Resel, Silvia Ortega-Gutierrez, María Laura García-Bermejo, Javier Fernández Ruiz, Manuel Guzmán, Justo García de Yébenes Prous

Article Affiliation:

Jose Luis López-Sendón Moreno


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.

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