A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III)

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2008-007520-26-DE
• Date of registration: 13/11/2009
• Prospective Registration: Yes
• Primary sponsor: Klinikum der Universität München
• Public title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III)
• Date of first enrolment: 24/06/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007520-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all inclusion criteria to be eligible:
1.Clinical signs of PSP. Diagnosis will be made for patients with clini-cal probable PSP (Litvan et al., 1996). Patients will be included with PSP stage 2.Patients, male or female, aged 50 to 80 years
3.Subjects whose clinical condition at the time of enrolment does not or requires a low [< / = 500 mg /day] stable dose of L-DOPA for at least 2 weeks prior to study entry
4.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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. No clinically probable PSP
2. No written informed consent possible
3. Age > 80 or < 50 years
4. Dementia (MMSE ? 24)
5. Subjects with clinically significant psychiatric illness, including major depression
6. Subjects who have taken any experimental drugs within 60 days prior to baseline
7. 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.
8. Loss of postural reflexes (no independent walking possible, inability to stand unassisted, wheelchair-bound)
9. Feeding tube / recommendation for a feeding tube
10. Unintelligible speech
11. History of brain disease (e.g. repeated strokes, cerebral tumour, hydrocephalus)
12. MPTP exposure
13. Oculogyric crisis
14. Early severe autonomic failure
15. Systemic disorder affecting the brain
16. Women who are not postmenopausal (e.g. one year without men-strual periods) or surgically sterilized.
17. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
18. Subjects who have used antidepressants, including selective sero-tonin re-uptake inhibitors, tricyclic and tetracyclic antidepressants (except amitriptyline <= 50 mg/day, trazodone < = 100 mg/day, ci-talopram < = 20 mg/ day, sertaline < = 100 mg/day and paroxetine < = 30 mg/day, escitalopram < = 10 mg/day) within 42 days prior to baseline
19. Subjects who have used any drugs known to have been involved in a drug interaction via inhibition of hepatic CYP 1A2 within 30 days prior to baseline (cimetidine, ciprofloxacin, clarithromycin, enoxacin, erythromycin, fluvoxamine, isoniazide, nalidixic acid, norfloxacin, troleandomycin, zileuton)
20. Subjects who have used MAO inhibitors including reserpine and methyldopa within three months prior to baseline
21. Anti-emetic or antipsychotic medication with central dopamine an-tagonist activity (except quetiapine fumarate) within six months prior to baseline
22. Participation in a clinical trial within the last 30 days prior to study start
23. Unstable antiparkinsonian medication within 30 days before base-line
24. Previous use of Rasagiline or Selegiline
25. Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study par-ticipation (based on the investigator’s judgment). Such conditions might include cardiovascular, vascular diseases, pulmonary, he-patic impairment (Child-Pugh score > 5), renal, or metabolic diseases or malignancies as determined by medical history, physical examination, laboratory tests, or ECG



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy
MedDRA version: 12.0 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy

Intervention(s)

Trade Name: Azilect
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagilin
CAS Number: 161735-79-1
Other descriptive name: RASAGILINE MESILATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1 mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary outcome measure will be the integral of the PSPRS changes from baseline over time measured during visits at 3, 6, 9, 12 months

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

Main Objective: To assess the efficacy of Rasagiline using the PSP 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.
To assess the need for additional L-DOPA therapy or the need to in-crease the dose of L-DOPA during the trial.

Secondary Objective: Reduction of gait disturbances and postural stability (as documented with posturographic measurement)
Clinical safety and tolerability will be assessed by findings of physical and neurological examination, laboratory variables, adverse events in-cidence, vital signs, ECG, assessment of survival time
Number of Subjects (%) who discontinue the study
Number of Subjects (%) who discontinue the study due to AEs
Assessment of survival time
Additional endpoints: Secondary efficacy variables also will include inci-dence of dysphagia, gastrostomia, depression and pneumonia

Secondary ID(s)

PROSPERA (Rasagiline)