Unilateral randomised double-blind placebo-controlled continuation of existing open-labelled intraputaminal GDNF (glial derived neurotrophic factor) infusion study for 6-months in subjects with idiopathic Parkinsons disease
| ISRCTN | ISRCTN67335687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67335687 |
| Secondary identifying numbers | N0234120876 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 23/09/2009
- 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 P Heywood
Scientific
Scientific
Department of Neurology
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom
| Phone | +44 (0)117 970 1212 |
|---|---|
| research@southmead.swest.nhs.uk |
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Unilateral randomised double-blind placebo controlled study. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/03/2003 |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 5 |
| Key inclusion criteria | Five patients currently enrolled in the open labelled study. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Neurology
Bristol
BS16 1ND
United Kingdom
BS16 1ND
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
North Bristol NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/02/2005 | Yes | No |
