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

Summary

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

Conditions

• REM Sleep Behavior Disorder
• Parkinson Disease

Interventions

DRUG

Idebenone

30mg tablets three times a day

DRUG

Placebo oral tablet

placebo tablets three times a day

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Tiantan Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Jiangsu Province Nanjing Brain Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Guizhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Peking University Shenzhen Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The Affiliated Hospital of Hangzhou Normal University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Baorong Zhang, MD · Second Affiliated Hospital of Zhejiang University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-01-01

Completion

2023-01-01

Countries

• China

Study Locations