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Sponsored by: |
Oxford BioMedica |
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Information provided by: | Oxford BioMedica |
ClinicalTrials.gov Identifier: | NCT00627588 |
The primary objectives of the trial are to assess the safety and efficacy of ProSavin. The analyses of patients will include the application of advanced non-invasive neuro-imaging techniques
Patients in the trial will have been diagnosed with Parkinson's disease and will be failing on current treatment with L-DOPA but they will not have progressed to drug-induced dyskinesias. It is a two-stage study. The first stage is an open-label dose escalation to evaluate two dose levels of ProSavin in cohorts of three patients each. In the second stage of the trial, a further 12 patients will be recruited to confirm efficacy of the optimal dose.
The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an efficacy assessment at six months after treatment. The secondary objective of the trial is to asses the extent to which patients' current therapy (L-DOPA) can be reduced following administration of ProSavin.
Condition | Intervention | Phase |
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Parkinson's Disease |
Biological: ProSavin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease. |
Estimated Enrollment: | 18 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose Evaluation: Experimental
To assess the safety and efficacy of up to two dose levels
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Biological: ProSavin
ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
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Sham element: Sham Comparator
The potential use of sham comparator to confirm efficacy
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Biological: ProSavin
ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
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Ages Eligible for Study: | 50 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elaine Smith | +44 (0)1865 783000 | enquiries@oxfordbiomedica.co.uk |
France | |
Henri Mondor Hospital | Recruiting |
Paris, France | |
Principal Investigator: Stephane Palfi, Prof |
Responsible Party: | Henri Mondor Hospital ( Prof. Stephane Palfi ) |
Study ID Numbers: | PS-001-07, EudraCT Number: 2007-001109-26 |
Study First Received: | January 31, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00627588 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
ProSavin Parkinson's Disease Gene Therapy |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Nervous System Diseases |