Rasagiline for Gait Treatment

NCT01098396 | Unknown

• 1 other identifier: TASMC-09-TG-0349
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Parkinson Disease

Keywords

parkinson disease; gait

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with PD

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: May 1, 2010
• Last Updated: April 2, 2010

Record last verified: 2009-09