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

Parkinson´s Disease Clinical Trial

Official title:

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

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:

• 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

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

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