NCT01098396
Unknown
Not Applicable
Rasagiline for the Treatment of Gait Disturbances in Patients With Parkinson´S Disease (PD): an Open Label Study
ConditionsParkinson Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Enrollment
- 10
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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