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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902941

Enrollment

Registered

2009-05-15

Start date

2009-05-31

Completion date

2012-02-29

Last updated

2012-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson´s Disease

Keywords

Parkinson´s disease, olfaction, rasagiline, smell testing

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.

Interventions

DRUGAzilect 1mg

1 mg daily orally for 120 days

DRUGPlacebo

1 mg daily orally for 120 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
olfactory function	4 months

Secondary

Measure	Time frame
quality of life	4 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026