SEASEiPPD: A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04152655

Collaborator

Peking Union Medical College Hospital (Other), Beijing Hospital (Other), Beijing Tiantan Hospital (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Jiangsu Province Nanjing Brain Hospital (Other), The First Affiliated Hospital of Anhui Medical University (Other), Huashan Hospital (Other), Tongji Hospital (Other), Second Affiliated Hospital of Soochow University (Other), Guizhou Medical University (Other), The First Affiliated Hospital of Guangzhou Medical University (Other), Peking University Shenzhen Hospital (Other), West China Hospital (Other), Wuhan Union Hospital, China (Other), Sir Run Run Shaw Hospital (Other), The Affiliated Hospital of Hangzhou Normal University (Other), The First Affiliated Hospital of Dalian Medical University (Other), Qilu Hospital of Shandong University (Other)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).

Condition or Disease	Intervention/Treatment	Phase
REM Sleep Behavior Disorder Parkinson Disease	Drug: Idebenone Drug: Placebo oral tablet	Phase 2/Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: idebenone 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	Drug: Idebenone 30mg tablets three times a day Other Names: Coenzyme Q10 analogue
Placebo Comparator: Group 2: placebo 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	Drug: Placebo oral tablet placebo tablets three times a day

Arm

Intervention/Treatment

Active Comparator: Group 1: idebenone

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

Drug: Idebenone

30mg tablets three times a day

Other Names:

Coenzyme Q10 analogue

Placebo Comparator: Group 2: placebo

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

Drug: Placebo oral tablet

placebo tablets three times a day

Outcome Measures

Primary Outcome Measures

Clinical diagnosis of parkinson disease [24 months]
based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015

Secondary Outcome Measures

Dopamine transporter positron emission tomography (DAT-PET) change [12 month and 24 month]
diminishment of striatal DAT-PET
Quantitative motor testing change [24 months]
Unified Parkinson Disease Rating Scale, Part III

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects are voluntary to participate and have signed informed consent
Diagnosed as Rapid Eye movement (REM) Sleep Behavior Disorder by polysomnography

Exclusion Criteria:

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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Wuhan Union Hospital, China
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

Investigators

Study Chair: Baorong Zhang, MD, Second Affiliated Hospital of Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04152655

Other Study ID Numbers:

2019-278

First Posted:

Nov 5, 2019

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

REM Sleep Behavior Disorder

Mental Disorders

Coenzyme Q10

Idebenone

Study Results

No Results Posted as of Jul 16, 2021