Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline

INTERVENTION: Trade Name: Azilect Pharmaceutical Form: Tablet INN or Proposed INN: Rasagilin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III ; MedDRA version: 13.1 Level: LLT Classification code 10034008 Term: Parkinson's syndrome System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: Reversibility of olfactory loss. Increase of 6 points within 120 days according to the SDI‐Score. Primary end point(s): SDI‐Score within 120 days Secondary Objective: ‐ PDQ‐39‐ Score; ‐ retronasale test value; ‐ latency and amplitude of olfactory evoked potentials Timepoint(s) of evaluation of this end point: SDI‐Score within 120 days SECONDARY OUTCOME: Secondary end point(s): ‐ PDQ‐39‐ Score ; ‐ retronasale test value ; ‐ latency and amplitude of olfactory evoked potentials Timepoint(s) of evaluation of this end point: aften 120 days INCLUSION CRITERIA: ‐ Idiopathic Parkinsons's Syndrome ‐ patients between 18 and 64 years ‐ anosmia ‐ written informend consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42