Rasagiline for Gait Treatment

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01098396
• Other study ID #: TASMC-09-TG-0349
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2010
• Last updated: April 1, 2010
• Start date: May 2010

Study information

• Verified date: September 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center