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Trial record 1 of 1 for:    NCT01856439
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Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01856439
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica

Brief Summary:
The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ProSavin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.
Study Start Date : May 2011
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Long term follow up
Long term follow up of patient's who received ProSavin in previous study
Drug: ProSavin
Long term follow up of patients who received ProSavin in a previous study



Primary Outcome Measures :
  1. To assess the long term safety and tolerability of ProSavin [ Time Frame: 10 years ]
    The number and severity of any adverse event


Secondary Outcome Measures :
  1. Patients' responses to ProSavin administration [ Time Frame: 10 years ]
    Assessed using Unified Parkinson's Disease Rating Score(UPDRS) Part III, evaluating percentage of time during waking day that patient is in the "off" state through patient diaries and activities of daily living using PDQ-39 at 36 months post administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must have met all inclusion criteria for study PS1/001/07
  • willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.
  • affiliated with the French social security health care system (Patients enrolled in France only)
  • signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations
  • must have been treated with ProSavin/Sham

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856439


Locations
France
Henri Mondor Hospital
Paris, France
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
Oxford BioMedica
Investigators
Principal Investigator: Stephane Palfi, Professor Henri Mondor Hospital
Principal Investigator: Roger Barker, Dr Addenbrookes Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01856439     History of Changes
Other Study ID Numbers: PS1/001/09
2009-017253-35 ( EudraCT Number )
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Oxford BioMedica:
ProSavin
Gene therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases