Progressive Supranuclear Palsy MedDRA version: 12.0 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy
Conditions
Interventions
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 typ
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. No clinically probable PSP 2. No written informed consent possible 3. Age > 80 or 5), renal, or metabolic diseases or malignancies as determined by medical history, physical examination, laboratory tests, or ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Outcome results
None listed