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Progressive Supranuclear PalsyPhase 3PROSPERANCT01187888

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

A Phase 3 study testing Rasagiline and Sugar pill in people with Progressive Supranuclear Palsy, run by Prof. Dr. Stefan Lorenzl at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Progressive Supranuclear Palsy
What is being tested?
Rasagiline and Sugar pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteGermany
Study dates
Jan 2010to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    München, 81377

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
Rasagiline, Sugar pill
Keywords
PSP, Progressive Supranuclear Palsy, Rasagiline, Azilect, PROSPERA
Medical subject headings
Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RasagilineDrug

    Also called Azilect

    tablet once daily 1 mg 1 year

  • Sugar pillDrug

    Also called Placebo

    tablet once daily one year

Study groups in NCT01187888
Study groupRoleWhat they receive
RasagilineActive comparatorNot described
Receives: Drug: Rasagiline
Sugar pillPlacebo comparatorNot described
Receives: Drug: Sugar pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Secondary outcomes (6)

  1. Reduction of gait disturbances and postural stability

    Measured: 1 year

  2. Adverse Event (AE) incidence

    Measured: 1 year

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

    Measured: 1 year

  4. Vital signs

    Measured: 1 year

  5. Number of subjects (%) who discontinue the study

    Measured: 1 year

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2012
  4. Study completionJun 2012

Why it stopped: IMP used off label by phys. in pat. with PSP. Thus no more eligible patients were available for the study(pre-treatm.with Rasagiline=exclusion criterion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187888
Sponsor's protocol ID
08P02
Other IDs
2008-007520-26, 2008
Acronym
PROSPERA
Status last verified
Apr 2013
First submitted
20 Aug 2010
Last updated
24 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rasagiline and Sugar pill in people with Progressive Supranuclear Palsy, run by Prof. Dr. Stefan Lorenzl at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: IMP used off label by phys. in pat. with PSP. Thus no more eligible patients were available for the study(pre-treatm.with Rasagiline=exclusion criterion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.

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