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OpenTrials
Completed

NCT Number: NCT00902941

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azilect 1mg

Drug

1 mg daily orally for 120 days

Placebo

Drug

1 mg daily orally for 120 days

Primary outcomes

  1. olfactory function

    Time frame: 4 months

Secondary outcomes

  1. quality of life

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 15, 2009
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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