A Study of Efficacy and Safety of Idebenone Vs. Placebo i... | NCT04152655

Studies
A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease

NCT04152655

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Withdrawn

Last Update Posted

Jan 7, 2025Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

REM Sleep Behavior Disorder
Parkinson Disease

Interventions

Idebenone
Placebo oral tablet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to COVID-19 pandemic, in-hospital polysomnography and visits were infeasible.

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Oct 7, 2019

First Submission Date that Met QC Criteria

Nov 3, 2019

First Posted Date

Nov 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2025

Last Update Posted Date

Jan 7, 2025Actual

Name	Class
Peking Union Medical College Hospital	OTHER
Beijing Hospital	OTHER_GOV
Beijing Tiantan Hospital	OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: Placebo oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Idebenone	Drug	30mg tablets three times a day	Group 1: idebenone	Coenzyme Q10 analogue

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baorong Zhang, MD	Second Affiliated Hospital of Zhejiang University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital of Zhejiang University School of Medicine		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020187	REM Sleep Behavior Disorder
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020923	REM Sleep Parasomnias
D020447	Parasomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided