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
Secondary identifying numbers Sponsor 583; Eudract test 0000632-21
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

Queen Elizabeth Psychiatric Hospital
Vincent Drive
Edgbaston
Birmingham
B15 2QZ
United Kingdom

Phone +44 (0)121 678 2019
Email hugh.rickards@bsmht.nhs.uk

Study information

Study designRandomised double blind placebo controlled crossover group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThat 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) studiedHuntington's disease
InterventionNabilone or placebo for 5 weeks, 5 week washout period cross over to nabilone or placebo for 5 weeks
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nabilone
Primary outcome measureMotor symptoms rated using the motor scale from the UHDRS
Secondary outcome measuresPsychiatric symptoms rated using the behavioural assessment of the UHDRS and the NPI
Overall study start date01/09/2005
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteriaCompetent patients with a clinical diagnosis of Huntington's disease over 18
Key exclusion criteria1. 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 enrolment01/09/2005
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom

Sponsor information

Birmingham and Solihull Mental Health Trust (UK)
Hospital/treatment centre

Uffculme Centre
Queensbridge Road
Moseley
Birmingham
B13 8QY
England
United Kingdom

Phone +44 (0)121 678 2731
Email theresa.morton@bsmht.nhs.uk
ROR logo "ROR" https://ror.org/00cjeg736

Funders

Funder type

Industry

Cambridge Laboratories (UK) - hold the European marketing rights for nabilone

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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