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

Phase 2

Withdrawn

• Conditions: REM Sleep Behavior Disorder; Parkinson Disease
• Interventions: Drug: Placebo oral tablet; Drug: Idebenone

• Registration Number: NCT04152655
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-11-03
• Study First Posted: 2019-11-05
• Study Start: 2020-01-01
• Status Verified: 2021-07
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: placebo	Placebo oral tablet	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
Group 1: idebenone	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China