Clinical trial NCT04152655: A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease
Official title: A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: REM Sleep Behavior Disorder
Parkinson Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Hospital
name: Beijing Tiantan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiangsu Province Nanjing Brain Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Huashan Hospital
name: Tongji Hospital
name: Second Affiliated Hospital of Soochow University
name: Guizhou Medical University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Peking University Shenzhen Hospital
name: West China Hospital
name: Wuhan Union Hospital, China
name: Sir Run Run Shaw Hospital
name: The Affiliated Hospital of Hangzhou Normal University
name: The First Affiliated Hospital of Dalian Medical University
name: Qilu Hospital of Shandong University
First posted: 2019-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical diagnosis of parkinson disease
timeFrame: 24 months
Secondary outcomes:
measure: Dopamine transporter positron emission tomography (DAT-PET) change
timeFrame: 12 month and 24 month
measure: Quantitative motor testing change
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Baorong Zhang, MD
role: STUDY_CHAIR
References: