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

NCT01187888 | Terminated Phase 3 DMC

• 2 other identifiers: 08P022008-007520-26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Supranuclear Palsy

Keywords

PSP; Progressive Supranuclear Palsy; Rasagiline; Azilect; PROSPERA

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 year

• Reduction of the reported deterioration using the PSP rating scale

  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.

  1 year

Secondary Outcomes (6)

• Reduction of gait disturbances and postural stability

  1 year

• Adverse Event (AE) incidence

  1 year

• Safety laboratory values (blood cell count, aspartate aminotransferase [AST], alanine aminotransferase [ALT], creatinine, Vitamin B12, folic acid, homocysteine and methylmalonic acid)

  1 year

• Vital signs

  1 year

• Number of subjects (%) who discontinue the study

  1 year

Study Arms (2)

Rasagiline

ACTIVE COMPARATOR

Drug: Rasagiline

Sugar pill

PLACEBO COMPARATOR

Drug: Sugar pill

Interventions

Rasagiline DRUG

tablet once daily 1 mg 1 year

Also known as: Azilect

Rasagiline

Sugar pill DRUG

tablet once daily one year

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• methyl-4-phenyl-1,2,5,6-tetrahydropyridine (MPTP) exposure
• Oculogyric crisis
• Early severe autonomic failure
• Systemic disorder affecting the brain

Sponsors & Collaborators

• Prof. Dr. Stefan Lorenzl: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Department of Neurology and Palliative Care Klinikum der Universität München (Hospital of the University of Munich)

München, 81377, Germany

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

rasagiline; Sugars

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Stefan Lorenzl, PD Dr.

  Klinikum der Universität München (Hospital of the University of Munich)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor Delegated Person, Hospital of the University of Munich

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 24, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

DE (1)