Parkinson´s DiseasePhase 4NCT00902941
Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline
A Phase 4 study testing Azilect 1mg in people with Parkinson´s Disease, run by Technische Universität Dresden at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Parkinson´s Disease
- What is being tested?
- Azilect 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Parkinson´s disease, Hoehn \& Yahr stage ≤ III
- aged 18-64 yrs
- hyposmia/functional anosmia defined as TDI<30
- written consent
Who cannot join
- 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
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- pregnant or breastfeeding women
- any contraindication for the treatment with Rasagiline
- women without reliable contraception
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology
Dresden, 01307
About this study
Official title: Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline
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
- Being tested
- Azilect 1mg, Placebo
- Keywords
- Parkinson´s disease, olfaction, rasagiline, smell testing
- Medical subject headings
- Parkinson Disease, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilect 1mgDrug
1 mg daily orally for 120 days
PlaceboDrug
1 mg daily orally for 120 days
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Experimental | Not described Receives: Drug: Azilect 1mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
olfactory function
Measured: 4 months
Secondary outcomes (1)
quality of life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson´s DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heinz Reichmann, MD, PhD, Principal investigator, University of Dresden Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902941
- Sponsor's protocol ID
- TUD-Olfact-035
- Other IDs
- 2008-005085-30, 2008
- Status last verified
- Feb 2012
- First submitted
- 13 May 2009
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline
- ClinicalTrials.gov ID
- NCT00902941
- Acronym / sponsor ID
- TUD-Olfact-035
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s disease, olfaction, rasagiline, smell testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Experimental | Drug: Azilect 1mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parkinson´s disease, Hoehn \& Yahr stage ≤ III
- aged 18-64 yrs
- hyposmia/functional anosmia defined as TDI<30
- written consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilect 1mg1 mg daily orally for 120 days | Drug | Rasagiline |
| Placebo1 mg daily orally for 120 days | Drug | Placebo |
Primary outcome
olfactory function
Time frame: 4 months
1 secondary outcome
quality of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz Reichmann, MD, PhD principal investigator
University of Dresden Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azilect 1mg in people with Parkinson´s Disease, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
olfactory function (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.