Contact information
Type
Scientific
Primary contact
Dr P Heywood
ORCID ID
Contact details
Department of Neurology
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom
+44 (0)117 970 1212
research@southmead.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234120876
Study information
Scientific title
Acronym
Study hypothesis
The open-labelled trial has to date established the long term safety and therapeutic benefits of chronic intraputaminal GDNF infusion in the five patients with Parkinson's disease. This trial aims to assess the clinical effect of unilateral randomised double-blinded placebo controlled cessation of GDNF for 6-months. Unilateral cessation of GDNF infusion may result in either contralateral stability or a reduction of the improved clinical state.
Ethics approval
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Parkinson's disease
Intervention
Unilateral randomised double-blind placebo controlled study.
Intervention type
Other
Phase
Phase I
Drug names
Primary outcome measures
1. Unified Parkinson's disease Rating Scores (UPDRS) - total and lateralised scores.
2. Timed motor tests.
3. Patient diary assessments.
4. Quality of life measures - PDQ-39 and SF-36.
5. Change in medication requirement. 18F-dopa positron emission tomography (PET) changes.
6. Safety assessments.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
01/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Five patients currently enrolled in the open labelled study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
5
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/03/2003
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurology
Bristol
BS16 1ND
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
North Bristol NHS Trust (UK)
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
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15668979
Publication citations
-
Results
Patel NK, Bunnage M, Plaha P, Svendsen CN, Heywood P, Gill SS, Intraputamenal infusion of glial cell line-derived neurotrophic factor in PD: a two-year outcome study., Ann. Neurol., 2005, 57, 2, 298-302, doi: 10.1002/ana.20374.