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

Brief Title

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

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 (Phase III)

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 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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Assessment of the need for additional L-DOPA therapy or the need to increase the dose of L-DOPA during the trial

Secondary Outcome

 Reduction of gait disturbances and postural stability

Condition

Progressive Supranuclear Palsy

Intervention

Rasagiline

Study Arms / Comparison Groups

 Rasagiline

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

44

Start Date

January 2010

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical signs of Progressive Supranuclear Palsy (PSP). Diagnosis will be made for
             patients with clinical probable PSP (Litvan et al., 1996). Patients will be included
             with PSP stage  80 or < 50 years

          -  Dementia (Mini-Mental State Examination [MMSE]  5), renal, or metabolic dis-eases or
             malignancies as determined by medical history, physical examination, laboratory tests,
             or ECG
      

Gender

All

Ages

50 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Stefan Lorenzl, PD Dr., , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT01187888

Organization ID

08P02

Secondary IDs

2008-007520-26

Responsible Party

Sponsor-Investigator

Study Sponsor

Prof. Dr. Stefan Lorenzl

Collaborators

 Teva Branded Pharmaceutical Products R&D, Inc.

Study Sponsor

Stefan Lorenzl, PD Dr., Principal Investigator, Klinikum der Universität München (Hospital of the University of Munich)

Verification Date

April 2013