PROSPERA

TerminatedPhase 3

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)

Lead sponsor

Prof. Dr. Stefan Lorenzl

Asset

Rasagiline

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age 50-80

Primary endpoints

•Assessment of the need for additional L-DOPA therapy or the need to increase•The reported deterioration

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID08P02

Eudract number2008-007520-26

NCT IDNCT01187888

Timeline

Milestones

Study start2010-01 (month precision)

Study first posted2010-08-24estimated

Primary completion2012-06actual (month precision)

Study completion2012-06actual (month precision)

Last update posted2013-04-24estimated

Assets

Drug assets

Rasagiline

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Adverse Event (AE) incidence

Time frame:1 year

event count, event

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

Vital signs

Time frame:1 year

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

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

descriptive

Primary/protocol endpoint/low confidence

Reduction of the reported deterioration using the PSP rating scale

Time frame:1 year

ratio, descriptive

Secondary/protocol endpoint/low confidence

Reduction of gait disturbances and postural stability

Time frame:1 year

descriptive

Secondary/protocol endpoint/low confidence

Number of subjects (%) who discontinue the study

Time frame:1 year

event count, event

Secondary/protocol endpoint/low confidence

Number of subjects (%) who discontinue the study due to AEs

Time frame:1 year

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.