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

Primary Purpose

REM Sleep Behavior Disorder, Parkinson Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Idebenone
Placebo oral tablet
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1: idebenone

Group 2: placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical diagnosis of parkinson disease
based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015

Secondary Outcome Measures

Dopamine transporter positron emission tomography (DAT-PET) change
diminishment of striatal DAT-PET
Quantitative motor testing change
Unified Parkinson Disease Rating Scale, Part III

Full Information

First Posted
October 7, 2019
Last Updated
July 14, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Peking Union Medical College Hospital, Beijing Hospital, Beijing Tiantan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Province Nanjing Brain Hospital, The First Affiliated Hospital of Anhui Medical University, Huashan Hospital, Tongji Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Peking University Shenzhen Hospital, West China Hospital, Wuhan Union Hospital, China, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Dalian Medical University, Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04152655
Brief Title
A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease
Acronym
SEASEiPPD
Official Title
A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: idebenone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2: placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Idebenone
Other Intervention Name(s)
Coenzyme Q10 analogue
Intervention Description
30mg tablets three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
placebo tablets three times a day
Primary Outcome Measure Information:
Title
Clinical diagnosis of parkinson disease
Description
based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Dopamine transporter positron emission tomography (DAT-PET) change
Description
diminishment of striatal DAT-PET
Time Frame
12 month and 24 month
Title
Quantitative motor testing change
Description
Unified Parkinson Disease Rating Scale, Part III
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baorong Zhang, MD
Phone
+86 13958167260
Email
brzhang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baorong Zhang, MD
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baorong Zhang, MD
Phone
+86 13958167260
Email
brzhang@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Baorong Zhang, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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