NCT04152655

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 7, 2025

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

October 7, 2019

Last Update Submit

January 5, 2025

Conditions

REM Sleep Behavior DisorderParkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical diagnosis of parkinson disease

    based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015

    24 months

Secondary Outcomes (2)

  • Dopamine transporter positron emission tomography (DAT-PET) change

    12 month and 24 month

  • Quantitative motor testing change

    24 months

Study Arms (2)

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

IdebenoneDRUG

30mg tablets three times a day

Also known as: Coenzyme Q10 analogue
Group 1: idebenone
Placebo oral tabletDRUG

placebo tablets three times a day

Group 2: placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

REM Sleep Behavior DisorderParkinson Disease

Interventions

idebenone

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Baorong Zhang, MD

    Second Affiliated Hospital of Zhejiang University School of Medicine

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

November 5, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

January 7, 2025

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)