Rasagiline for Gait Treatment

Condition(s) targeted: Parkinson Disease

Phase: N/A

Status: Not yet recruiting

Sponsored by: Tel-Aviv Sourasky Medical Center

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).

Official title: Rasagiline for the Treatment of Gait Disturbances in Patients With Parkinson´S Disease (PD): an Open Label Study

Study design: Observational Model: Case-Only

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Starting date: May 2010
Last updated: April 1, 2010