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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Rasagiline in Subjects With Progressive Supranuclear Palsy

Brief 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 Summary: 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.
Sponsor: Prof. Dr. Stefan Lorenzl

Current Primary Outcome:

• Assessment of the need for additional L-DOPA therapy or the need to increase the dose of L-DOPA during the trial [ Time Frame: 1 year ]
  Since there is no established treatment regimen for Progressive Supranuclear Palsy (PSP) patients, the only well characterized medication is L-3,4-Dihydroxyphenylalanine (L-DOPA) therapy. Since this therapy may exert a small effect in PSP patients, begin with L-DOPA therapy or increase in L-DOPA therapy will be used in this trial as rescue medication.
• Reduction of the reported deterioration using the PSP rating scale [ Time Frame: 1 year ]
  To assess the efficacy of Rasagiline using the Progressive Supranuclear Palsy Rating Scale (PSPRS), aiming at a 33% reduction of the reported deterioration (Golbe et. al., 2007), i.e. a mean yearly increase of 6.5 instead of 9.7 points.

Original Primary Outcome:

• Assessment of the need for additional L-DOPA therapy or the need to increase the dose of L-DOPA during the trial [ Time Frame: 1 year ]
  Since there is no established treatment regimen for Progressive Supranuclear Palsy (PSP) patients, the only well characterized medication is L-3,4-Dihydroxyphenylalanine (L-DOPA) therapy. Since this therapy may exerct a small effect in PSP patients, begin with L-DOPA therapy or increase in L-DOPA therapy will be used in this trial as rescue medication.
• Reduction of the reported deterioration using the PSP rating scale [ Time Frame: 1 year ]
  To assess the efficacy of Rasagiline using the Progressive Supranuclear Palsy Rating Scale (PSPRS), aiming at a 33% reduction of the reported deterioration (Golbe et. al., 2007), i.e. a mean yearly increase of 6.5 instead of 9.7 points.

Current Secondary Outcome:

• Reduction of gait disturbances and postural stability [ Time Frame: 1 year ]
• Adverse Event (AE) incidence [ Time Frame: 1 year ]
• Safety laboratory values (blood cell count, aspartate aminotransferase [AST], alanine aminotransferase [ALT], creatinine, Vitamin B12, folic acid, homocysteine and methylmalonic acid) [ Time Frame: 1 year ]
• Vital signs [ Time Frame: 1 year ]
• Number of subjects (%) who discontinue the study [ Time Frame: 1 year ]
• Number of subjects (%) who discontinue the study due to AEs [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Ludwig-Maximilians - University of Munich

Dates:
Date Received: August 20, 2010
Date Started: January 2010
Date Completion:
Last Updated: April 23, 2013
Last Verified: April 2013