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

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).

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; REM Sleep Behavior Disorder
• Intervention / Treatment: Drug: Idebenone; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Baorong Zhang, MD; Phone Number: +86 13958167260; Email: brzhang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Baorong Zhang, MD; Phone Number: +86 13958167260; Email: brzhang@zju.edu.cn
      • Principal Investigator: Baorong Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	24 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Peking Union Medical College Hospital; Beijing Tiantan Hospital; Huashan Hospital; West China Hospital; Tongji Hospital; Qilu Hospital of Shandong University; Guizhou Medical University; Beijing Hospital; The First Affiliated Hospital of Guangzhou Medical University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Wuhan Union Hospital, China; Sir Run Run Shaw Hospital; Peking University Shenzhen Hospital; Second Affiliated Hospital of Soochow University; The First Affiliated Hospital of Dalian Medical University; The Affiliated Hospital of Hangzhou Normal University; Jiangsu Province Nanjing Brain Hospital
• Investigators: Study Chair: Baorong Zhang, MD, Second Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parasomnias; REM Sleep Parasomnias; Parkinson Disease; Mental Disorders; REM Sleep Behavior Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Coenzyme Q10; Idebenone
• Other Study ID Numbers: 2019-278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No