Neuroprotection by Cannabinoids in Huntington's Disease

Plain-language summary

This study examined the potential nerve-protecting effect of cannabinoids (THC and CBD) compared with placebo in people with Huntington's disease. It enrolled patients over 18 who met certain movement and cognitive criteria. It was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Intervention

delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Placebo

Start date

9/1/2011

Estimated completion

6/1/2012

Countries

Spain

Related genes

Locations

• Madrid, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients with HD
2. Older than 18 years.
3. Able to understand the study, to attend the study visits and to provide informed consent.
4. Stable baseline medication for at least 6 weeks prior to randomization.
5. Score in the UHDRS-motor from 5 to 50.
6. 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.
7. Not consumers of products derived from marijuana.

Exclusion Criteria:

1. Pregnant or lactating women.
2. History of drug addition.
3. History of psychosis or with history of suicidal attempt.
4. Patients with diseases of the oral cavity that prevents the safe administration of the drug.
5. Patients in which drug administration is contraindicated according to the SmPC