NCT03727295: ITEP

Idebenone Treatment of Early Parkinson's Diseasesymptoms

Status unknown Phase 4 Last updated 1 November 2018

What this trial tests

Phase 4 trial testing Idebenone/placebo in Oxidative Stress is an Important Cause of Parkinson's Disease in 180 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
30 December 2020

30 May 2021

Quick facts

Lead sponsor	Second Affiliated Hospital of Soochow University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	1 January 2019
Primary completion	30 December 2020
Estimated completion	30 May 2021

Drugs / interventions tested

• Idebenone/placebo

Conditions studied

• Oxidative Stress is an Important Cause of Parkinson's Disease — all drugs for Oxidative Stress is an Important Cause of Parkinson's Disease →

Sponsor

Second Affiliated Hospital of Soochow University

Who can join

Adults 30 to 80, any sex, with Oxidative Stress is an Important Cause of Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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。

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological advances in mitochondrial therapy.
   Singh A, Faccenda D, Campanella M. · · 2021 · cited 88× · PMID 33647769 · DOI 10.1016/j.ebiom.2021.103244
2. Recent Advances in Drug Therapy for Parkinson's Disease.
   Murakami H, Shiraishi T, Umehara T, Omoto S, et al · · 2023 · cited 57× · PMID 35110492 · DOI 10.2169/internalmedicine.8940-21
3. Mitochondrial Function and Parkinson's Disease: From the Perspective of the Electron Transport Chain.
   Li JL, Lin TY, Chen PL, Guo TN, et al · · 2021 · cited 40× · PMID 34955747 · DOI 10.3389/fnmol.2021.797833
4. The Dichotomous Role of Inflammation in the CNS: A Mitochondrial Point of View.
   Vezzani B, Carinci M, Patergnani S, Pasquin MP, et al · · 2020 · cited 32× · PMID 33066071 · DOI 10.3390/biom10101437
5. Alpha synuclein post translational modifications: potential targets for Parkinson's disease therapy?
   Brembati V, Faustini G, Longhena F, Bellucci A. · · 2023 · cited 27× · PMID 37305556 · DOI 10.3389/fnmol.2023.1197853
6. The Mitochondrial Foundations of Parkinson's Disease: Therapeutic Implications.
   Soman SK, Woodruff MRJ, Dagda RK. · · 2025 · cited 4× · PMID 40540721 · DOI 10.14336/ad.2025.0440