Rasagiline for Gait Treatment

• Conditions: Parkinson Disease

• Registration Number: NCT01098396
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Gait disturbances are very common and are a major cause for losing of independency in patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances in advanced PD is very difficult and in many cases the classical dopaminergic treatment has no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new MAO-B inhibitor who has recently been approved all over the world for the treatment of early and late stages PD has been suggested to have a special effect of gait in patients with advanced PD (LARGO sub-study).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Last Update Submitted: 2010-04-01
• Study First Posted: 2010-04-02
• Last Update Posted: 2010-04-02
• Study Start: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with PD who experience motor response fluctuations and have gait disturbances at ON and OFF (TUaG >10 secs in ON and 14 secs in OFF) treated with a stable dose of antiparkinsonian medications for the last month. Patients must be able to identify both situations
• Able to walk for 2 minutes at the OFF and ON state
• Non-demented (MMSE= or > to25)

Exclusion Criteria

• Severe orthopedic problems
• Orthostatic hypotension on basal visit
• Severe, troublesome ON dyskinesias
• Dementia (MMSE <25)
• Major depression
• Active psychosis or on anti-psychotic medications
• Patients who are unlikely to complete the full protocol.
• Patients who have tried rasagiline and stopped because of side effects or lack of symptomatic effect
• Treatment with selegiline for the last 2 months
• Any contraindication according SmPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified