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Rasagiline for Gait Treatment

Rasagiline for Gait Treatment

Last Updated: 2010-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers