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 Information
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 = II (Golbe et al., 1997), at least with a PSPRS < 40 (Golbe et al., 2007) and according to the diagnostic criteria resumed after the Neuroprotection and Natural History in Parkinson Plus Syndromes (NNIPPS) trial (Bensimon et al., 2009) - Patients, male or female, aged 50 to 80 years - Subjects whose clinical condition at the time of enrolment does not or requires a low [= 500 mg /day] stable dose of L-3,4-Dihydroxyphenylalanine (L-DOPA) for at least 2 weeks prior to study entry - Capability and willingness to give written signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: - No clinically probable PSP - No written informed consent possible - Age > 80 or < 50 years - Dementia (Mini-Mental State Examination [MMSE] = 24) - Subjects with clinically significant psychiatric illness, including major depression - Subjects who have taken any experimental drugs within 60 days prior to baseline - Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's wort within 7 days prior to baseline. - Loss of postural reflexes (no independent walking possible, inability to stand unassisted, wheelchair-bound) - Feeding tube / recommendation for a feeding tube - Unintelligible speech - History of brain disease (e.g. repeated strokes, cerebral tumour, hydrocephalus) - 1-methyl-4-phenyl-1,2,5,6-tetrahydropyridine (MPTP) exposure - Oculogyric crisis - Early severe autonomic failure - Systemic disorder affecting the brain - Women who are not postmenopausal (e.g. one year without menstrual periods) or surgically sterilized. - Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure - Subjects who have used antidepressants, including selective serotonin re-uptake inhibitors, tricyclic and tetracyclic antidepressants (except amitriptyline <= 50 mg/day, trazodone < = 100 mg/day, citalopram < = 20 mg/ day, sertraline < = 100 mg/day and paroxetine < = 30 mg/day, escitalopram < = 10 mg/day) within 42 days prior to baseline - Subjects who have used any drugs known to have been involved in a drug interaction via inhibition of hepatic Cytochrome P450 1A2 (CYP 1A2) within 30 days prior to baseline (cimetidine, ciprofloxacin, clarithromycin, enoxacin, erythromycin, fluvoxamine, isoniazide, nalidixic acid, norfloxacin, troleandomycin, zileuton) - Subjects who have used Monoamine oxidase (MAO) inhibitors including reserpine and methyldopa within three months prior to baseline - Anti-emetic or antipsychotic medication with central dopamine antagonist activity (except quetiapine fumarate) within six months prior to baseline - Participation in a clinical trial within the last 30 days prior to study start - Unstable antiparkinsonian medication within 30 days before baseline - Previous use of Rasagiline or Selegiline - Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation (based on the investigator's judgment). Such conditions might include cardiovascular, vascular diseases, pulmonary, hepatic impairment (Child-Pugh score > 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
Administrative Informations
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