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Status unknownNCT03727295ITEPUpdated Nov 1, 2018

Idebenone Treatment of Early Parkinson's Diseasesymptoms

A Phase 4 interventional study of Idebenone/placebo in Oxidative Stress is an Important Cause of Parkinson's Disease, sponsored by Second Affiliated Hospital of Soochow University. Status unknown. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Second Affiliated Hospital of Soochow University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study summary

On May 30,2018 ,Investigators intend to conduct a multicenter, randomized, double-blind, placebo-controlled study of idebenone in the treatment of early-stage Parkinson's disease with motor and non-motor symptoms which is to observe the therapeutic effect of idebenone on motor symptoms and non-motor symptoms in patients with early Parkinson's disease。

Read the detailed description

This clinical trail was a multicenter, parallel, randomized, double-blind, placebo-controlled study led by Professor Liu Chunfeng from the Second Affiliated Hospital of Suzhou University which consisted of 15 sub-centers with a total of 180 subjects.

This clinical study is divided into two phases:

The first stage: double-blind period, 24 weeks. Three queues containing idebenone 180 mg/d,360 mg/d and placebo.

The second stage: open label extension period, 24 weeks. All enrolled participants continued to take idebenone 180 mg/d to study the long-term effects of idebenone.

02

Conditions studied

  • Oxidative Stress is an Important Cause of Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 180 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • (1) Male or female, age > 30 years old, ≤ 80 years old;
  • (2) Conforms to the "Diagnostic Criteria for Parkinson's Disease" developed by the 2015 International Association of Sports Disabilities (MDS);
  • (3) Patients with early Parkinson's disease, duration \<3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points;
  • (4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment;
  • (5) The subjects need to sign the Informed Consent Form（ICF）

Exclusion criteria

Exclusion Criteria:

  • (1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)
  • (2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)
  • (3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);
  • (4)Patients who have taken coenzyme Q10 or idebenone within three months;
  • (5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;
  • (6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);
  • (7)Patients who cannot cooperate with the neuropsychological test;
  • (8) Patients with poor compliance, not following the prescribed treatment regimen.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    The control group 1

    60 cases, idebenone 180mg/d, 3 times / day, oral

    Drug: Idebenone/placebo

  • Experimental
    The control group 2

    60 cases, idebenone 360mg/d, 3 times / day, oral

    Drug: Idebenone/placebo

  • Placebo comparator
    The placebo group

    60 cases, placebo, 3 times / day, oral

    Drug: Idebenone/placebo

Interventions

  • DrugIdebenone/placebo

    The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo

06

What researchers measure

Primary outcomes

  1. Evaluation of the efficacy on motor symptoms and non-motor symptoms

    UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)

    Time frame: 48weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03727295
Lead sponsor
Second Affiliated Hospital of Soochow University
Collaborators
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 1, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Dec 30, 2020 (estimated)
Completion
May 30, 2021 (estimated)
Last update
Nov 1, 2018

Study contacts

Chun Feng Liu, Professor
Contact
13606210609

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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