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ISRCTN
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ISRCTN67335687
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0234120876
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nervous System Diseases: Parkinson's disease
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Participants - inclusion criteria
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Five patients currently enrolled in the open labelled study.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/2003
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Anticipated end date
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01/10/2003
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Status of trial
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Completed
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Patient information material
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Target number of participants
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5
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Interventions
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Unilateral randomised double-blind placebo controlled study.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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North Bristol NHS Trust
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Trial website
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Publications
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Contact name
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Dr
P
Heywood
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Address
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Department of Neurology
North Bristol NHS Trust
Frenchay Hospital
Frenchay
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City/town
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Bristol
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Zip/Postcode
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BS16 1ND
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Country
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United Kingdom
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Tel
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+44 0117 970 1212
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Fax
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+44 0117 975 3824
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Email
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research@southmead.swest.nhs.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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21/11/2005
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Date ISRCTN assigned
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12/09/2003
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