We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.
- Authors
López-Sendón Moreno, Jose Luis; García Caldentey, Juan; Trigo Cubillo, Patricia; Ruiz Romero, Carolina; García Ribas, Guillermo; Alonso Arias, M.; García de Yébenes, María Jesús; Tolón, Rosa María; Galve-Roperh, Ismael; Sagredo, Onintza; Valdeolivas, Sara; Resel, Eva; Ortega-Gutierrez, Silvia; García-Bermejo, María Laura; Fernández Ruiz, Javier; Guzmán, Manuel; García de Yébenes Prous, Justo
- 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
- Subjects
HUNTINGTON'S chorea treatment; CANNABINOIDS; PLANT extracts; TETRAHYDROCANNABINOL; PLACEBOS; BIOMARKERS
- Publication
Journal of Neurology, 2016, Vol 263, Issue 7, p1390
- ISSN
0340-5354
- Publication type
Article
- DOI
10.1007/s00415-016-8145-9