| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN67335687 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0234120876 |
| Public title | 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous System Diseases: Parkinson's disease |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Five patients currently enrolled in the open labelled study. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/03/2003 |
| Anticipated end date | 01/10/2003 |
| Status of trial | Completed |
| Target number of participants | 5 |
| Interventions | Unilateral randomised double-blind placebo controlled study. |
| Primary outcome measure(s) | Unified Parkinson's disease Rating Scores (UPDRS) - total and lateralised scores. Timed motor tests. Patient diary assessments. Quality of life measures - PDQ-39 and SF-36. Change in medication requirement. 18F-dopa positron emission tomography (PET) changes. Safety assessments. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | North Bristol NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr P Heywood |
| Contact details | Department of Neurology
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
United Kingdom
BS16 1ND |
| Contact telephone | +44 0117 970 1212 |
| Contact fax | +44 0117 975 3824 |
| Contact email | research@southmead.swest.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN67335687 |
| Date last extracted from ISRCTN register | 17/04/2008 |
