REM Sleep Behavior DisorderPhase 2/3SEASEiPPDNCT04152655
A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease
A Phase 2/3 study testing Idebenone in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder, Parkinson Disease
- What is being tested?
- Idebenone
- 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
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are voluntary to participate and have signed informed consent
- Diagnosed as Rapid Eye movement (REM) Sleep Behavior Disorder by polysomnography
Who cannot join
- Subjects are pregnant, breastfeeding, or want to get pregnant or breastfeeding in 2 years
- Subjects have history of allergy to idebenone
- Difficulty to communicate
- Suffering from neurodegenerative diseases
- Having obvious brain imaging abnormalities (eg. severe brain atrophy, malformation, softening lesions, cerebrovascular disease, intracranial occupancy, giant large benign lesions, etc.)
- Having severe mental illness (eg. schizophrenia, manic depression, and severe depression)
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- Long-term use of clonidine, dopamine antagonists, and serotonin reuptake inhibitors
- Suffering from other severe medical conditions
- Having difficulty in moving and are unable to come to the hospital
- Having claustrophobia
- Having contraindications to MRI tests
- Having history of olfactory disorders greater than 10 years
- Having history of color vision disorders greater than 10 years
- Life expectancy less than 2 years
- Having other situations which researchers consider is inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)
To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).
Read the detailed description
Number of people suffered from Parkinson disease (PD) is increasing every year. Contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed PD emerges. The concept of Prodromal Parkinson disease (PPD) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. Rapid eye movement (REM) sleep behavior disorder and olfactory dysfunction are the most common PPD, and more than one third of patients may progress to PD and other neurodegenerative diseases. Mitochondrial injury is one of the pathogenesis of PD. Thus we design this trial to investigate whether idebenone, potent coenzyme Q10 analogue, could protect PPD develops into PD.
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease
- Being tested
- Idebenone, Placebo oral tablet
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdebenoneDrug
Also called Coenzyme Q10 analogue
30mg tablets three times a day
Placebo oral tabletDrug
placebo tablets three times a day
| Study group | Role | What they receive |
|---|---|---|
| Group 1: idebenone | Active comparator | Oral 30 mg fixed dose three times a day x 24-months (90 mg total / day) with assessments @ baseline, 3 month, 6 month, 12 month, 15 month, 18 month, 21 month and 24 months Receives: Drug: Idebenone |
| Group 2: placebo | Placebo comparator | Oral placebo three times a day x 24-months with assessments @ baseline, 3 month, 6 month, 12 month, 15 month, 18 month, 21 month and 24 months Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical diagnosis of parkinson disease
based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015
Measured: 24 months
Secondary outcomes (2)
Dopamine transporter positron emission tomography (DAT-PET) change
diminishment of striatal DAT-PET
Measured: 12 month and 24 month
Quantitative motor testing change
Unified Parkinson Disease Rating Scale, Part III
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Why it stopped: Due to COVID-19 pandemic, in-hospital polysomnography and visits were infeasible.
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
- Peking Union Medical College Hospital, Beijing Hospital, 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, Tongji Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Peking University Shenzhen Hospital, West China Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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
- Responsible party
- Sponsor
- Investigators
- Baorong Zhang, MD, Study chair, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152655
- Sponsor's protocol ID
- 2019-278
- Acronym
- SEASEiPPD
- Status last verified
- Jul 2021
- First submitted
- 7 Oct 2019
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)
- ClinicalTrials.gov ID
- NCT04152655
- Acronym / sponsor ID
- SEASEiPPD / 2019-278
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 pandemic, in-hospital polysomnography and visits were infeasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Hospital, 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, Tongji Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Peking University Shenzhen Hospital, West China Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 5 Nov 2019 (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 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).
Detailed description
Number of people suffered from Parkinson disease (PD) is increasing every year. Contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed PD emerges. The concept of Prodromal Parkinson disease (PPD) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. Rapid eye movement (REM) sleep behavior disorder and olfactory dysfunction are the most common PPD, and more than one third of patients may progress to PD and other neurodegenerative diseases. Mitochondrial injury is one of the pathogenesis of PD. Thus we design this trial to investigate whether idebenone, potent coenzyme Q10 analogue, could protect PPD develops into 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 |
|---|---|---|
| Group 1: idebenone | Active comparator | Drug: IdebenoneOral 30 mg fixed dose three times a day x 24-months (90 mg total / day) with assessments @ baseline, 3 month, 6 month, 12 month, 15 month, 18 month, 21 month and 24 months |
| Group 2: placebo | Placebo comparator | Drug: Placebo oral tabletOral placebo three times a day x 24-months with assessments @ baseline, 3 month, 6 month, 12 month, 15 month, 18 month, 21 month and 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects are voluntary to participate and have signed informed consent
- Diagnosed as Rapid Eye movement (REM) Sleep Behavior Disorder by polysomnography
Key exclusion criteria (15 listed)
- Subjects are pregnant, breastfeeding, or want to get pregnant or breastfeeding in 2 years
- Subjects have history of allergy to idebenone
- Difficulty to communicate
- Suffering from neurodegenerative diseases
- Having obvious brain imaging abnormalities (eg. severe brain atrophy, malformation, softening lesions, cerebrovascular disease, intracranial occupancy, giant large benign lesions, etc.)
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 |
|---|---|---|
| IdebenoneAlso: Coenzyme Q10 analogue30mg tablets three times a day | Drug | Group 1: idebenone |
| Placebo oral tabletplacebo tablets three times a day | Drug | Group 2: placebo |
Primary outcome
Clinical diagnosis of parkinson disease
Time frame: 24 months
based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015
2 secondary outcomes
Dopamine transporter positron emission tomography (DAT-PET) change
Time frame: 12 month and 24 month
Quantitative motor testing change
Time frame: 24 months
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: Yes
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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 study chair
Second Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Idebenone in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 2 inclusion and 15 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.
Where is the study taking place?
The record lists 1 site in China. 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 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?
Clinical diagnosis of parkinson disease (time frame: 24 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 Jan 2025.