Condition category
Nervous System Diseases
Date applied
07/09/2005
Date assigned
13/09/2005
Last edited
01/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hugh Rickards

ORCID ID

Contact details

Queen Elizabeth Psychiatric Hospital
Vincent Drive
Edgbaston
Birmingham
B15 2QZ
United Kingdom
+44 (0)121 678 2019
hugh.rickards@bsmht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor 583; Eudract test 0000632-21

Study information

Scientific title

Acronym

Study hypothesis

That nabilone will have a beneficial effect on movement and psychiatric symptoms in patients with Huntington's disease

Ethics approval

Not provided at time of registration

Study design

Randomised double blind placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Nabilone

Primary outcome measures

Motor symptoms rated using the motor scale from the UHDRS

Secondary outcome measures

Psychiatric symptoms rated using the behavioural assessment of the UHDRS and the NPI

Overall trial start date

01/09/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Competent patients with a clinical diagnosis of Huntington's disease over 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom

Sponsor information

Organisation

Birmingham and Solihull Mental Health Trust (UK)

Sponsor details

Uffculme Centre
Queensbridge Road
Moseley
Birmingham
B13 8QY
United Kingdom
+44 (0)121 678 2731
theresa.morton@bsmht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19845035

Publication citations

  1. Results

    Curtis A, Mitchell I, Patel S, Ives N, Rickards H, A pilot study using nabilone for symptomatic treatment in Huntington's disease., Mov. Disord., 2009, 24, 15, 2254-2259, doi: 10.1002/mds.22809.

Additional files

Editorial Notes