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

NCT ID: NCT00902941

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-02-29

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.

Conditions

Parkinson´s Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rasagiline

Group Type: EXPERIMENTAL

Azilect 1mg

Intervention Type: DRUG

1 mg daily orally for 120 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 mg daily orally for 120 days

Interventions

Azilect 1mg

1 mg daily orally for 120 days

Intervention Type: DRUG

Placebo

1 mg daily orally for 120 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heinz Reichmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dresden Medical School

Locations

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

Dresden, , Germany

Countries

Germany

Other Identifiers

2008-005085-30

Identifier Type: -

Identifier Source: secondary_id

TUD-Olfact-035

Identifier Type: -

Identifier Source: org_study_id