Parkinson's DiseasePhase 4PD-SOARNCT01007630
A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by The Parkinson's Institute at 1 site in United States.
Trial summary
A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease even in the earliest stages of the disease. There have been no treatments that have been proven to improve sense of smell in patients with Parkinson's Disease. Rasagiline (brand name: Azilect) was approved by the U.S. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rasagiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2014
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women with Parkinson's Disease (PD), defined as the presence of at least two of the cardinal signs of PD (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
- Functional hyposmia or anosmia, as defined by UPSIT scores less than the 25th percentile for age- and gender-matched norms
- Have been on stable dose of PD medications for at least 30 days
- Age < or = 90 years
- Willing and able to give informed consent
- Women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. Women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
Who cannot join
- Prior use of an MAO inhibitor, including selegiline or rasagiline within the last 12 months
- Presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (Zicam) use, history of smoking within the past year
- Presence of dementia or significant cognitive impairment with Mini-Mental State Examination (MMSE) < 24
- Present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
- Use of any experimental medication within 60 days of baseline
- Use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
- Use of any medication contraindicated with use of rasagiline (Investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Parkinson's Institute
Sunnyvale, California, 94085
About this study
Official title: A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease
A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease even in the earliest stages of the disease. There have been no treatments that have been proven to improve sense of smell in patients with Parkinson's Disease.
Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA) on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated with the disease. The purpose of this study is to see if there is change in sense of smell after starting Rasagiline.
Read the detailed description
This study will last approximately 10 weeks.
- 2 visits to The Parkinson's Institute in Sunnyvale, California
- 1 phone call between visits
You will be asked to take either Rasagiline (Azilect) or placebo (an identical pill without active ingredients)
- 5 in 6 chance of receiving Rasagiline (Azilect)
- 1 in 6 chance of receiving placebo
- Neither you nor the study team will know which you are assigned
- This information will be available in case of emergency
To be eligible for this study, you must:
- be 90 years old or younger
- have a decreased loss of smell or complete loss of smell
- have not taken Selegiline or Rasagiline within the past 12 months
- have not smoked within the last year
- be on a stable dose of Parkinson's medication (or not on any PD medicines)
- have no history of head trauma, nasal surgery, nasal inflammation causing congestion or polyps, nasal/sinus infection, or prior Zicam use
- have not used decongestants, antihistamine or inhaled steroids within 2 weeks of the study and be willing to avoid such treatments during the study
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Parkinson's, Parkinsons, Parkinson, Parkinson's Disease, PD, Rasagiline, Azilect, Olfactory, Sense of Smell, UPSIT
- 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.
RasagilineDrug
Also called Brand Name: Azilect
0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
PlaceboDrug
0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Active comparator | 0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total). Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | 0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in UPSIT score at 10-week visit
Measured: 10 weeks
Secondary outcomes (2)
Tolerability: Number of subjects (%) who discontinue the study due to AEs
Measured: 10 weeks
Safety: AE incidence
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Parkinson's Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Neuroscience, Inc.
- Responsible party
- Principal investigator, Grace Liang, The Parkinson's Institute
- Investigators
- Grace S Liang, MD, Principal investigator, The Parkinson's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007630
- Sponsor's protocol ID
- PD-SOAR
- Acronym
- PD-SOAR
- Status last verified
- Nov 2013
- First submitted
- 3 Nov 2009
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01007630
- Acronym / sponsor ID
- PD-SOAR / PD-SOAR
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's, Parkinsons, Parkinson, Parkinson's Disease, PD, Rasagiline, Azilect, Olfactory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Parkinson's InstituteUniversity, hospital or other
- Collaborators
- Teva Neuroscience, Inc.
- Study start
- Nov 2009
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 4 Nov 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.
A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease even in the earliest stages of the disease. There have been no treatments that have been proven to improve sense of smell in patients with Parkinson's Disease.
Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA) on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated with the disease. The purpose of this study is to see if there is change in sense of smell after starting Rasagiline.
Detailed description
This study will last approximately 10 weeks.
- 2 visits to The Parkinson's Institute in Sunnyvale, California
- 1 phone call between visits
You will be asked to take either Rasagiline (Azilect) or placebo (an identical pill without active ingredients)
- 5 in 6 chance of receiving Rasagiline (Azilect)
- 1 in 6 chance of receiving placebo
- Neither you nor the study team will know which you are assigned
- This information will be available in case of emergency
To be eligible for this study, you must:
- be 90 years old or younger
- have a decreased loss of smell or complete loss of smell
- have not taken Selegiline or Rasagiline within the past 12 months
- have not smoked within the last year
- be on a stable dose of Parkinson's medication (or not on any PD medicines)
- have no history of head trauma, nasal surgery, nasal inflammation causing congestion or polyps, nasal/sinus infection, or prior Zicam use
- have not used decongestants, antihistamine or inhaled steroids within 2 weeks of the study and be willing to avoid such treatments during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Active comparator | Drug: Rasagiline0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total). |
| Placebo | Placebo comparator | Drug: Placebo0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total) |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women with Parkinson's Disease (PD), defined as the presence of at least two of the cardinal signs of PD (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
- Functional hyposmia or anosmia, as defined by UPSIT scores less than the 25th percentile for age- and gender-matched norms
- Have been on stable dose of PD medications for at least 30 days
- Age < or = 90 years
- Willing and able to give informed consent
Key exclusion criteria (7 listed)
- Prior use of an MAO inhibitor, including selegiline or rasagiline within the last 12 months
- Presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (Zicam) use, history of smoking within the past year
- Presence of dementia or significant cognitive impairment with Mini-Mental State Examination (MMSE) < 24
- Present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
- Use of any experimental medication within 60 days of baseline
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 |
|---|---|---|
| RasagilineAlso: Brand Name: Azilect0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total) | Drug | Rasagiline |
| Placebo0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total) | Drug | Placebo |
Primary outcome
Change from baseline in UPSIT score at 10-week visit
Time frame: 10 weeks
2 secondary outcomes
Tolerability: Number of subjects (%) who discontinue the study due to AEs
Time frame: 10 weeks
Safety: AE incidence
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- The Parkinson's Institute Clinical Trials WebsiteLink provided by the sponsor.
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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.
Grace S Liang, MD principal investigator
The Parkinson's Institute
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 Rasagiline in people with Parkinson's Disease, run by The Parkinson's Institute at 1 site in United States.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Dec 2013. 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 United States. 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?
Results are not available in the source record.
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?
Change from baseline in UPSIT score at 10-week visit (time frame: 10 weeks). 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 2 Dec 2013.