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

NCT00902941 | Completed Phase 4 DMC

• 2 other identifiers: TUD-Olfact-0352008-005085-30
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson´s disease; olfaction; rasagiline; smell testing

Outcome Measures

Primary Outcomes (1)

• olfactory function

  4 months

Secondary Outcomes (1)

• quality of life

  4 months

Study Arms (2)

Rasagiline

EXPERIMENTAL

Drug: Azilect 1mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azilect 1mg DRUG

1 mg daily orally for 120 days

Rasagiline

Placebo DRUG

1 mg daily orally for 120 days

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parkinson´s disease, Hoehn \& Yahr stage ≤ III
• aged 18-64 yrs
• hyposmia/functional anosmia defined as TDI\<30
• written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Parkinson Disease; Anosmia

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heinz Reichmann, MD, PhD

  University of Dresden Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: May 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

DE (1)