Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline

This study has been completed.
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
First received: May 13, 2009
Last updated: February 6, 2012
Last verified: February 2012
There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.

Condition Intervention Phase
Parkinson´s Disease
Drug: Azilect 1mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline

Resource links provided by NLM:

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • olfactory function [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: May 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline Drug: Azilect 1mg
1 mg daily orally for 120 days
Placebo Comparator: Placebo Drug: Placebo
1 mg daily orally for 120 days


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parkinson´s disease, Hoehn & Yahr stage ≤ III
  • aged 18-64 yrs
  • hyposmia/functional anosmia defined as TDI<30
  • written consent

Exclusion Criteria:

  • congenital olfactory loss
  • significant infections of the nose and nasal sinuses
  • diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc.
  • dementia, psychiatric illness, addictive behaviour
  • smoker
  • severe liver disease
  • pregnant or breastfeeding women
  • any contraindication for the treatment with Rasagiline
  • women without reliable contraception
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00902941

University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Heinz Reichmann, MD, PhD University of Dresden Medical School
  More Information

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00902941     History of Changes
Other Study ID Numbers: TUD-Olfact-035  2008-005085-30 
Study First Received: May 13, 2009
Last Updated: February 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Parkinson´s disease
smell testing

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2016