PARKINSON DISEASE (Disorder)Phase 4NCT07077187
Effect of Rasagiline on Balance in Parkinson's Disease as Measured by Computerized Posturography
A Phase 4 study testing computerized dynamic posturography and Rasagiline 1 mg capsule in people with PARKINSON DISEASE (Disorder), run by New York Medical College.
Trial summary
This study evaluates the effect of rasagiline on balance in Parkinson's disease. Participants taking study medication which is rasagiline or sugar pill will undergo a computerized balance test on and off medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- computerized dynamic posturography and Rasagiline 1 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2014to 10 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or above
- Clinical diagnosis of Parkinson disease by verified by movement disorders expert at the initial study visit with at least two cardinal signs of the disease (rest tremor, bradykinesia, rigidity, and postural instability).
- For the monotherapy arm, patients must not be on amantadine, dopamine agonists, or levodopa. For the adjuvant therapy arm: Patients must be on a stable dose of their current medication for treatment of Parkinson disease which may include any combination of the following: amantadine, trihexiphenydil, dopamine agonist, and/or levodopa.
- Patients may continue their stable dose of tricyclic, selective serotonin reuptake inhibitor, or serotonin norepinephrine reuptake inhibitor if they are on these medications at randomization.
Who cannot join
- Catechol-O-Methyltransferase (COMT) inhibitor therapy use 30 days prior to start of study (both study arms).
- Dopamine receptor blocker use (such as quetiapine) one week prior to taking study drug
- For both monotherapy and adjuvant therapy arms: use of MAO inhibitor therapy including selegiline or rasagiline within 30 days prior to taking study drug and first posturography evaluation.
About this study
This study evaluates the effect of rasagiline on balance in Parkinson's disease. Participants taking study medication which is rasagiline or sugar pill will undergo a computerized balance test on and off medication. Participants will stand on a platform which which moves slightly and a computer will measure their body sway and provide a balance score.
Read the detailed description
The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- computerized dynamic posturography, Rasagiline 1 mg capsule, Placebo
- Keywords
- balance, posturography, computerized dynamic posturography, rasagiline, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized dynamic posturographyDiagnostic test
Patients in each arm will have computerized dynamic posturography performed at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other Parkinson disease medications.
Rasagiline 1 mg capsuleDrug
Rasagiline 1 mg oral tablet daily will be administered to study participants.
PlaceboDrug
Placebo 1 mg oral tablet daily will be administered to study participants.
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline monotherapy | Active comparator | Participants will be taking rasagiline 1 mg oral tablet daily Receives: Diagnostic Test: computerized dynamic posturography; Drug: Rasagiline 1 mg capsule |
| placebo monotherapy | Placebo comparator | Participants will be taking placebo 1 mg orally daily. Receives: Diagnostic Test: computerized dynamic posturography; Drug: Placebo |
| rasagiline adjuvant therapy | Active comparator | Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication. Receives: Diagnostic Test: computerized dynamic posturography; Drug: Rasagiline 1 mg capsule |
| placebo adjuvant therapy | Placebo comparator | Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication. Receives: Diagnostic Test: computerized dynamic posturography; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Dynamic Posturography Strategy Composite Score
Change from baseline to week 8 measurement of Computerized Dynamic Posturography Strategy Composite Score will be compared among the 4 arms of the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Sep 2014
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Why it stopped: Funding for the study could not be obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Model description
- The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance. Subjects will be evaluated at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other PD medications.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Fekete, New York Medical College
- Investigators
- Robert Fekete, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077187
- Sponsor's protocol ID
- L-10,768
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Institutional Review Board approval explicitly marked clinical study data as protected patient data and stated that data will be stored locally.
Publications
Ondo WG, Almaguer M, Cohen H. Computerized posturography balance assessment of patients with bilateral ventralis intermedius nuclei deep brain stimulation. Mov Disord. 2006 Dec;21(12):2243-7. doi: 10.1002/mds.21165.
PubMed 17078067
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rasagiline on Balance in Parkinson's Disease as Measured by Computerized Posturography
- ClinicalTrials.gov ID
- NCT07077187
- Acronym / sponsor ID
- L-10,768
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- balance, posturography, computerized dynamic posturography, rasagiline, Parkinson disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for the study could not be obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 22 Jul 2025 (actual)
- 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.
This study evaluates the effect of rasagiline on balance in Parkinson's disease. Participants taking study medication which is rasagiline or sugar pill will undergo a computerized balance test on and off medication. Participants will stand on a platform which which moves slightly and a computer will measure their body sway and provide a balance score.
Detailed description
The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance. Subjects will be evaluated at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other PD medications.
| Arm | Type | Receives |
|---|---|---|
| Rasagiline monotherapy | Active comparator | Diagnostic Test: computerized dynamic posturography, Drug: Rasagiline 1 mg capsuleParticipants will be taking rasagiline 1 mg oral tablet daily |
| placebo monotherapy | Placebo comparator | Diagnostic Test: computerized dynamic posturography, Drug: PlaceboParticipants will be taking placebo 1 mg orally daily. |
| rasagiline adjuvant therapy | Active comparator | Diagnostic Test: computerized dynamic posturography, Drug: Rasagiline 1 mg capsuleParticipants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication. |
| placebo adjuvant therapy | Placebo comparator | Diagnostic Test: computerized dynamic posturography, Drug: PlaceboParticipants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or above
- Clinical diagnosis of Parkinson disease by verified by movement disorders expert at the initial study visit with at least two cardinal signs of the disease (rest tremor, bradykinesia, rigidity, and postural instability).
- For the monotherapy arm, patients must not be on amantadine, dopamine agonists, or levodopa. For the adjuvant therapy arm: Patients must be on a stable dose of their current medication for treatment of Parkinson disease which may include any combination of the following: amantadine, trihexiphenydil, dopamine agonist, and/or levodopa.
- Patients may continue their stable dose of tricyclic, selective serotonin reuptake inhibitor, or serotonin norepinephrine reuptake inhibitor if they are on these medications at randomization.
Key exclusion criteria (3 listed)
- Catechol-O-Methyltransferase (COMT) inhibitor therapy use 30 days prior to start of study (both study arms).
- Dopamine receptor blocker use (such as quetiapine) one week prior to taking study drug
- For both monotherapy and adjuvant therapy arms: use of MAO inhibitor therapy including selegiline or rasagiline within 30 days prior to taking study drug and first posturography evaluation.
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 |
|---|---|---|
| computerized dynamic posturographyPatients in each arm will have computerized dynamic posturography performed at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other Parkinson disease medications. | Diagnostic test | Rasagiline monotherapy, placebo adjuvant therapy, placebo monotherapy, rasagiline adjuvant therapy |
| Rasagiline 1 mg capsuleRasagiline 1 mg oral tablet daily will be administered to study participants. | Drug | Rasagiline monotherapy, rasagiline adjuvant therapy |
| PlaceboPlacebo 1 mg oral tablet daily will be administered to study participants. | Drug | placebo adjuvant therapy, placebo monotherapy |
Primary outcome
Computerized Dynamic Posturography Strategy Composite Score
Time frame: 8 weeks
Change from baseline to week 8 measurement of Computerized Dynamic Posturography Strategy Composite Score will be compared among the 4 arms of the study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 17078067Ondo WG, Almaguer M, Cohen H. Computerized posturography balance assessment of patients with bilateral ventralis intermedius nuclei deep brain stimulation. Mov Disord. 2006 Dec;21(12):2243-7. doi: 10.1002/mds.21165.
- Individual participant dataSharing planned: No. Institutional Review Board approval explicitly marked clinical study data as protected patient data and stated that data will be stored locally.
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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.
Robert Fekete, MD principal investigator
New York Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing computerized dynamic posturography and Rasagiline 1 mg capsule in people with PARKINSON DISEASE (Disorder), run by New York Medical College.
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 3 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: withdrawn, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Computerized Dynamic Posturography Strategy Composite Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077187, which also lists 1 linked publication.
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 24 Jul 2025.