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

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

Detailed Description
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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.

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

Conditions
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REM Sleep Behavior Disorder, Parkinson Disease

Intervention / Treatment
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* Drug: Idebenone
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: idebenone<br>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<br>* 30mg tablets three times a day<br>* Other names: Coenzyme Q10 analogue;|
| Placebo Comparator: Group 2: placebo<br>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<br>* placebo tablets three times a day<br>|

What is the study measuring?
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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 |