A randomised, double-blind, placebo-controlled, cross-over pilot study using nabilone for symptomatic relief in patients with Huntington's disease
| ISRCTN | ISRCTN16782845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16782845 |
| Protocol serial number | Sponsor 583; Eudract test 0000632-21 |
| Sponsor | Birmingham and Solihull Mental Health Trust (UK) |
| Funder | Cambridge Laboratories (UK) - hold the European marketing rights for nabilone |
- Submission date
- 07/09/2005
- Registration date
- 13/09/2005
- Last edited
- 01/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hugh Rickards
Scientific
Scientific
Queen Elizabeth Psychiatric Hospital
Vincent Drive
Edgbaston
Birmingham
B15 2QZ
United Kingdom
| Phone | +44 (0)121 678 2019 |
|---|---|
| hugh.rickards@bsmht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled crossover group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That nabilone will have a beneficial effect on movement and psychiatric symptoms in patients with Huntington's disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Huntington's disease |
| Intervention | Nabilone or placebo for 5 weeks, 5 week washout period cross over to nabilone or placebo for 5 weeks |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nabilone |
| Primary outcome measure(s) |
Motor symptoms rated using the motor scale from the UHDRS |
| Key secondary outcome measure(s) |
Psychiatric symptoms rated using the behavioural assessment of the UHDRS and the NPI |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key inclusion criteria | Competent patients with a clinical diagnosis of Huntington's disease over 18 |
| Key exclusion criteria | 1. Under 18 2. Known allergy to cannabinoids 3. Liver dysfunction 4. Personal or family history of psychosis 5. Heart disease or hypertension 6. Pregnant or lactating |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom
B15 2QZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/11/2009 | Yes | No |
