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

Conditions: Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III
MedDRA version: 13.1Level: LLTClassification code 10034008Term: Parkinson's syndromeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2008-005085-30-DE

Lead Sponsor: Technische Universität Dresden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

- treatment with other MAO-inhibitors, Pethidin, Fluoxetin oder Fluvoxamin
- strong liver insufficy
- congenital scent disorder
- essential physical impairment (e. g. Asthma, traumatic brain injury, renal insufficy)
- acute or chronic (para)nasal sinusitis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reversibility of olfactory loss. Increase of 6 points within 120 days according to the SDI-Score.;Secondary Objective: - PDQ-39- Score<br>- retronasale test value<br>- latency and amplitude of olfactory evoked potentials;Primary end point(s): SDI-Score within 120 days;Timepoint(s) of evaluation of this end point: SDI-Score within 120 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - PDQ-39- Score<br>- retronasale test value<br>- latency and amplitude of olfactory evoked potentials;Timepoint(s) of evaluation of this end point: aften 120 days