NCT01187888

Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Rasagiline in Subjects With Progressive Supranuclear Palsy (Phase III)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Prof. Dr. Stefan Lorenzl · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether rasagiline is effective in the treatment of Progressive Supranuclear Palsy (PSP), a rapidly progressing disease with a symptomatology similar to Parkinson's Disease. The major aim of this study is the limitation or halting of the process of neurodegeneration and influence postural instability.

Detailed description

Progressive Supranuclear Palsy (PSP) is a rapidly progressing disease with a median survival after onset of symptoms of 5.8 years.PSP is characterized by early falls, vertical ophthalmoparesis, akinetic-rigid features, prominent bulbar dysfunction and fronto-subcortical dementia. So far there is no treatment for the disease as the negative outcomes of the vast majority of studies make it impossible to set standards. As the majority of patients experience severe falls and vertigo already in the early phase of the disease, the drug of desire would be able to slow disease progression with a special focus on postural instability and exert neuroprotective effects. The monoamino oxidase inhibitor Rasagiline might be able to influence progression of PSP.

Conditions

• Progressive Supranuclear Palsy

Interventions

Type	Name	Description
DRUG	Rasagiline	tablet once daily 1 mg 1 year
DRUG	Sugar pill	tablet once daily one year

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-08-24
• Last updated: 2013-04-24

Locations

1 site across 1 country: Germany