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Rasagiline for Gait Treatment

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01098396
Collaborator
(none)
10
Enrollment

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Official Title:
    Rasagiline for the Treatment of Gait Disturbances in Patients With Parkinson´S Disease (PD): an Open Label Study
    Study Start Date :
    May 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Tel-Aviv Sourasky Medical Center

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01098396
      Other Study ID Numbers:
      • TASMC-09-TG-0349
      First Posted:
      Apr 2, 2010
      Last Update Posted:
      Apr 2, 2010
      Last Verified:
      Sep 1, 2009
      Keywords provided by , ,
      parkinson disease
      gait
      Additional relevant MeSH terms:
      Parkinson Disease

      Study Results

      No Results Posted as of Apr 2, 2010