ClinicalTrials.gg
WithdrawnNCT05611372Updated Jan 7, 2025

Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

A Phase 2/3 interventional study of Rasagiline in REM Sleep Behavior Disorder, Parkinson Disease and Synucleinopathies, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Withdrawn. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
No suitable recruitment
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).

02

Conditions studied

  • REM Sleep Behavior Disorder
  • Parkinson Disease
  • Synucleinopathies
03

In context

REM Sleep Behavior Disorder

101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.

Browse REM Sleep Behavior Disorder studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Early Intervention

    0-52 week: rasagiline 1 mg/day

    Drug: Rasagiline

  • Active comparator
    Delayed Intervention

    0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day

    Drug: Rasagiline

Interventions

06

What researchers measure

Primary outcomes

  1. Disease-free survival time

    Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)

    Time frame: 3 years after starting rasagiline treatment

Secondary outcomes

  1. Striatal dopaminergic innervation

    Striatal binding ratio from DAT-Scan

    Time frame: 0-3 years after starting rasagiline treatment

  2. MDS-UPDRS-III

    Time frame: 0-3 years after starting rasagiline treatment

  3. MoCA

    Time frame: 0-3 years after starting rasagiline treatment

  4. MMSE

    Time frame: 0-3 years after starting rasagiline treatment

  5. HAMA

    Time frame: 0-3 years after starting rasagiline treatment

  6. HAMD

    Time frame: 0-3 years after starting rasagiline treatment

  7. RBDQ-HK

    Time frame: 0-3 years after starting rasagiline treatment

  8. PSQI

    Time frame: 0-3 years after starting rasagiline treatment

  9. PDQ39

    Time frame: 0-3 years after starting rasagiline treatment

  10. SCOPA-AUT

    Time frame: 0-3 years after starting rasagiline treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05611372
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
First posted
Nov 10, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 7, 2025

Study contacts

Baorong Zhang, MD
principal investigator · Second Affiliated Hospital, Zhejiang University, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Rasagiline

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