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

Axovant Sciences

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: ProSavin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01856439

2009-017253-35 (EudraCT Number)

PS1/001/09

Details and patient eligibility

About

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 .

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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• willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Long term follow up

Other group

Description:

Long term follow up of patient's who received ProSavin in previous study

Treatment:

Drug: ProSavin