Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-26 @ 5:05 PM
Study NCT ID:
NCT03727295
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Idebenone Treatment of Early Parkinson's Diseasesymptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C036619', 'term': 'idebenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the efficacy on motor symptoms and non-motor symptoms', 'timeFrame': '48weeks', 'description': 'UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Oxidative Stress is an Important Cause of Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "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。", 'detailedDescription': '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.\n\nThis clinical study is divided into two phases:\n\nThe first stage: double-blind period, 24 weeks. Three queues containing idebenone 180 mg/d,360 mg/d and placebo.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Male or female, age \\> 30 years old, ≤ 80 years old;\n* (2) Conforms to the "Diagnostic Criteria for Parkinson\'s Disease" developed by the 2015 International Association of Sports Disabilities (MDS);\n* (3) Patients with early Parkinson\'s disease, duration \\<3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points;\n* (4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment;\n* (5) The subjects need to sign the Informed Consent Form（ICF）\n\nExclusion Criteria:\n\n* (1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)\n* (2)Patients with Parkinson\'s superimposition syndrome and patients with secondary Parkinson\'s syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)\n* (3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);\n* (4)Patients who have taken coenzyme Q10 or idebenone within three months;\n* (5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;\n* (6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);\n* (7)Patients who cannot cooperate with the neuropsychological test;\n* (8) Patients with poor compliance, not following the prescribed treatment regimen.'}, 'identificationModule': {'nctId': 'NCT03727295', 'acronym': 'ITEP', 'briefTitle': "Idebenone Treatment of Early Parkinson's Diseasesymptoms", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Soochow University'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'SZDX-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The control group 1', 'description': '60 cases, idebenone 180mg/d, 3 times / day, oral', 'interventionNames': ['Drug: Idebenone/placebo']}, {'type': 'EXPERIMENTAL', 'label': 'The control group 2', 'description': '60 cases, idebenone 360mg/d, 3 times / day, oral', 'interventionNames': ['Drug: Idebenone/placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'description': '60 cases, placebo, 3 times / day, oral', 'interventionNames': ['Drug: Idebenone/placebo']}], 'interventions': [{'name': 'Idebenone/placebo', 'type': 'DRUG', 'description': 'The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo', 'armGroupLabels': ['The control group 1', 'The control group 2', 'The placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chun Feng Liu, Professor', 'role': 'CONTACT', 'phone': '13606210609'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}