Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
23/09/2009
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 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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes