Status:
COMPLETED
Neuroprotection by Cannabinoids in Huntington's Disease
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
GW Pharmaceuticals Ltd
Conditions:
Huntington's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 abnorma...
Eligibility Criteria
Inclusion
- Patients with HD
- Older than 18 years.
- Able to understand the study, to attend the study visits and to provide informed consent.
- Stable baseline medication for at least 6 weeks prior to randomization.
- Score in the UHDRS-motor from 5 to 50.
- Good cognitive status (MMSE\> 25) at the screening visit, with no evidence of major depression, at the discretion of the attending physician, and no evidence of psychosis.
- Not consumers of products derived from marijuana.
Exclusion
- Pregnant or lactating women.
- History of drug addition.
- History of psychosis or with history of suicidal attempt.
- Patients with diseases of the oral cavity that prevents the safe administration of the drug.
- Patients in which drug administration is contraindicated according to the SmPC
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01502046
Start Date
September 1 2011
End Date
June 1 2012
Last Update
February 1 2013
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034