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

Primary Purpose

Parkinson´s Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Azilect 1mg
Placebo
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s disease, olfaction, rasagiline, smell testing

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rasagiline

Placebo

Arm Description

Outcomes

Primary Outcome Measures

olfactory function

Secondary Outcome Measures

quality of life

Full Information

First Posted
May 13, 2009
Last Updated
February 6, 2012
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00902941
Brief Title
Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline
Official Title
Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
Parkinson´s disease, olfaction, rasagiline, smell testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rasagiline
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azilect 1mg
Intervention Description
1 mg daily orally for 120 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 mg daily orally for 120 days
Primary Outcome Measure Information:
Title
olfactory function
Time Frame
4 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Reichmann, MD, PhD
Organizational Affiliation
University of Dresden Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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

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