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Clinical Trials/NCT00902941
NCT00902941
Completed
Phase 4

Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline

Technische Universität Dresden1 site in 1 country34 target enrollmentMay 2009

Overview

Phase
Phase 4
Intervention
Azilect 1mg
Conditions
Parkinson´s Disease
Sponsor
Technische Universität Dresden
Enrollment
34
Locations
1
Primary Endpoint
olfactory function
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
February 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • severe liver disease
  • pregnant or breastfeeding women
  • any contraindication for the treatment with Rasagiline
  • women without reliable contraception

Arms & Interventions

Rasagiline

Intervention: Azilect 1mg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

olfactory function

Time Frame: 4 months

Secondary Outcomes

  • quality of life(4 months)

Study Sites (1)

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