Idebenone Treatment of Early Parkinson's Diseasesymptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03727295
• Date of registration: 30/10/2018
• Prospective Registration: Yes
• Primary sponsor: Second Affiliated Hospital of Soochow University
• Public title: Idebenone Treatment of Early Parkinson's Diseasesymptoms ITEP
• Scientific title: 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
• Date of first enrolment: January 1, 2019
• Target sample size: 180
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03727295
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Contacts

• Name: Chun Feng Liu, Professor

Key inclusion & exclusion criteria

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:

- (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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Oxidative Stress is an Important Cause of Parkinson's Disease

Intervention(s)

Drug: Idebenone/placebo

Primary Outcome(s)

Evaluation of the efficacy on motor symptoms and non-motor symptoms [Time Frame: 48weeks]

Secondary ID(s)

SZDX-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Qilu Pharmaceutical Co., Ltd.