Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01856439
First received: May 14, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: ProSavin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Oxford BioMedica:

Primary Outcome Measures:
  • To assess the long term safety and tolerability of ProSavin [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The number and severity of any adverse event


Secondary Outcome Measures:
  • Patients' responses to ProSavin administration [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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  • willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Oxford BioMedica

Additional 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
Study First Received: May 14, 2013
Last Updated: June 9, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014