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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00902941
First received: May 13, 2009
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902941

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

No publications provided

Responsible Party: Dresden University of Technology
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 Dresden University of Technology:
Parkinson´s disease
olfaction
rasagiline
smell testing

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

ClinicalTrials.gov processed this record on May 19, 2013