REM Sleep Behavior DisorderPhase 2/3NCT05611372
Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease
A Phase 2/3 study testing Rasagiline in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies
- What is being tested?
- Rasagiline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Phase 2/3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline)
- no clinical diagnosis of Parkinson's disease or dementia at baseline
- age 30-75
- no concomitant or previous use of any other anti-parkinson medications
- provide written informed consent
Who cannot join
- diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic)
- secondary RBD (eg., drug-induced, immune-mediated)
- nervous system comorbidities (eg., stroke, epilepsy, encephalitis)
- severe psychiatric comorbidities
- allergic to rasagiline
- severe systemic diseases (eg., end-stage kidney disease, liver failure)
About this study
To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).
- Being tested
- Rasagiline
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
1 mg rasagiline
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | 0-52 week: rasagiline 1 mg/day Receives: Drug: Rasagiline |
| Delayed Intervention | Active comparator | 0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day Receives: Drug: Rasagiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time
Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)
Measured: 3 years after starting rasagiline treatment
Secondary outcomes (10)
Striatal dopaminergic innervation
Striatal binding ratio from DAT-Scan
Measured: 0-3 years after starting rasagiline treatment
MDS-UPDRS-III
Measured: 0-3 years after starting rasagiline treatment
MoCA
Measured: 0-3 years after starting rasagiline treatment
MMSE
Measured: 0-3 years after starting rasagiline treatment
HAMA
Measured: 0-3 years after starting rasagiline treatment
HAMD
Measured: 0-3 years after starting rasagiline treatment
RBDQ-HK
Measured: 0-3 years after starting rasagiline treatment
PSQI
Measured: 0-3 years after starting rasagiline treatment
PDQ39
Measured: 0-3 years after starting rasagiline treatment
SCOPA-AUT
Measured: 0-3 years after starting rasagiline treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: No suitable recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Province Nanjing Brain Hospital, The First Affiliated Hospital of Anhui Medical University, Huashan Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Dalian Medical University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital
- Responsible party
- Sponsor
- Investigators
- Baorong Zhang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611372
- Sponsor's protocol ID
- SAHZJU_RBD
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05611372
- Acronym / sponsor ID
- SAHZJU_RBD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No suitable recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Province Nanjing Brain Hospital, The First Affiliated Hospital of Anhui Medical University, Huashan Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Dalian Medical University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (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.
To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).
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 |
|---|---|---|
| Early Intervention | Experimental | Drug: Rasagiline0-52 week: rasagiline 1 mg/day |
| Delayed Intervention | Active comparator | Drug: Rasagiline0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline)
- no clinical diagnosis of Parkinson's disease or dementia at baseline
- age 30-75
- no concomitant or previous use of any other anti-parkinson medications
- provide written informed consent
Key exclusion criteria (6 listed)
- diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic)
- secondary RBD (eg., drug-induced, immune-mediated)
- nervous system comorbidities (eg., stroke, epilepsy, encephalitis)
- severe psychiatric comorbidities
- allergic to rasagiline
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 |
|---|---|---|
| Rasagiline1 mg rasagiline | Drug | Delayed Intervention, Early Intervention |
Primary outcome
Disease-free survival time
Time frame: 3 years after starting rasagiline treatment
Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)
10 secondary outcomes
Striatal dopaminergic innervation
Time frame: 0-3 years after starting rasagiline treatment
MDS-UPDRS-III
Time frame: 0-3 years after starting rasagiline treatment
MoCA
Time frame: 0-3 years after starting rasagiline treatment
MMSE
Time frame: 0-3 years after starting rasagiline treatment
HAMA
Time frame: 0-3 years after starting rasagiline treatment
HAMD
Time frame: 0-3 years after starting rasagiline treatment
RBDQ-HK
Time frame: 0-3 years after starting rasagiline treatment
PSQI
Time frame: 0-3 years after starting rasagiline treatment
PDQ39
Time frame: 0-3 years after starting rasagiline treatment
SCOPA-AUT
Time frame: 0-3 years after starting rasagiline treatment
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Baorong Zhang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rasagiline in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 5 inclusion and 6 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 7 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Disease-free survival time (time frame: 3 years after starting rasagiline treatment). 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 Jan 2025.