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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902941
First Posted: May 15, 2009
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität Dresden
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902941


Locations
Germany
University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Technische Universität Dresden:
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
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs