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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00902941
Other study ID # TUD-Olfact-035
Secondary ID 2008-005085-30
Status Completed
Phase Phase 4
First received May 13, 2009
Last updated February 6, 2012
Start date May 2009
Est. completion date February 2012

Study information

Verified date February 2012
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- ParkinsonĀ“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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Azilect 1mg
1 mg daily orally for 120 days
Placebo
1 mg daily orally for 120 days

Locations

Country Name City State
Germany University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology Dresden

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary olfactory function 4 months No
Secondary quality of life 4 months No
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