Clinical Trials Logo

Clinical Trial Summary

Huntington's disease (HD) is a progressive neurodegenerative disorder, related to an abnormal expansion of CAG triplets in the huntingtin gene, characterized by motor, cognitive and behavioral abnormalities, without known effective symptomatic treatment and without known disease slowing strategy. The most severe neuropathological lesions observed in HD take place in the striatum, one brain area important in motor control and rich in cannabinoid receptors (CBR). CBR are subdivided in two classes: CB1R are located in neurons and play a role in neuronal function; CB2R in brain are located mostly in microglia and modulate neuroinflammation.

CBR disappear early in the course of HD, before there is a massive drop out of cells in the striatum. Cannabinoid transmission is also an early event in brains of animal models of HD. In R6/2 mice, which carry large CAG expansions and develop an early and severe HD phenotype the suppression of the CB1R gene further accelerate the development of a severe clinical syndrome and the characteristic brain inclusions and abnormalities of synaptic density. R6/2 treated mice treated with cannabinoids improve their clinical phenotype, their brain lesions, the synaptic density and the levels of BNDF, a neurotrophic factor which enhances survival and resistance of striatal neurons.

Preliminary studies of cannabinoids in patients with HD have shown that these compounds are safe in these patients. Those studies, however, did not show efficacy because 1) they were underpowered from the statistical point of view, 2) were performed with isolated pure cannabinoids, instead of the more physiological stimulation with a mixture of compounds, and 3) they did use insensitive clinical parameters instead of sensitive end points, such as pathogenically important biomarkers.

The investigators propose a phase II trial with combination of cannabinoids with evaluation of safety, by the profile of adverse events, and efficacy, according to changes of important biomarkers


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01502046
Study type Interventional
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date June 2012

See also
  Status Clinical Trial Phase
Recruiting NCT04120493 - Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease Phase 1/Phase 2
Completed NCT02956148 - Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers Early Phase 1
Terminated NCT02494778 - A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease Phase 2
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT02208934 - Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers Phase 1
Completed NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease Phase 2
Completed NCT01806896 - Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease Phase 2
Terminated NCT00712426 - Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) Phase 3
Completed NCT00670709 - Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
Completed NCT00029874 - Minocycline in Patients With Huntington's Disease Phase 1/Phase 2
Terminated NCT02231580 - Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients Phase 2
Completed NCT02215616 - A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod Phase 2
Not yet recruiting NCT02551705 - Functional Imaging of Social Cognition in Premanifest Huntington's Disease N/A
Active, not recruiting NCT02101957 - Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103) Phase 2/Phase 3
Completed NCT00990613 - A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin Phase 1
Completed NCT00975481 - A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users Phase 1
Completed NCT01521832 - Escalating Dose Study in Healthy Volunteers With SEN0014196 Phase 1
Completed NCT00387270 - Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT00095355 - Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease Phase 2
Completed NCT00026988 - Creatine Therapy for Huntington's Disease Phase 1/Phase 2