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

Parkinson Disease Clinical Trial

— SEASEiPPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152655
• Other study ID #: 2019-278
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Baorong Zhang, MD
• Phone: +86 13958167260
• Email: brzhang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• REM Sleep Behavior Disorder

Intervention

Drug:
• Idebenone
30mg tablets three times a day
• Placebo oral tablet
placebo tablets three times a day

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (19)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Beijing Hospital, Beijing Tiantan Hospital, Guizhou Medical University, Huashan Hospital, Jiangsu Province Nanjing Brain Hospital, Peking Union Medical College Hospital, Peking University Shenzhen Hospital, Qilu Hospital of Shandong University, Second Affiliated Hospital of Soochow University, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Guangzhou Medical University, Tongji Hospital, West China Hospital, Wuhan Union Hospital, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical diagnosis of parkinson disease	based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015	24 months
Secondary	Dopamine transporter positron emission tomography (DAT-PET) change	diminishment of striatal DAT-PET	12 month and 24 month
Secondary	Quantitative motor testing change	Unified Parkinson Disease Rating Scale, Part III	24 months