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

Einfluss von Rasagilin auf das Riechvermögen von Patienten mit idiopathischem Parkinson-Syndrom (Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline) - Olfaction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005085-30-DE
Enrollment
Unknown
Registered
2009-03-04
Start date
2009-04-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

Technische Universität Dresden
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Reversibility of olfactory loss. Increase of 6 points within 120 days according to the SDI-Score.;Secondary Objective: - PDQ-39- Score - retronasale test value - 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

MeasureTime frame
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—

Countries

Germany

Contacts

Public ContactGabriele Schulze

Koordinierungszentrum üpr Klinische Strudien Dresden

gabriele.schulze@uniklinikum-dresden.de04935145818624

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026