Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-03-09 @ 9:19 AM
Study NCT ID:
NCT01278004
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005013', 'term': 'Ethosuximide'}], 'ancestors': [{'id': 'D013388', 'term': 'Succinimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adult cancer patients with chemotherapy-induced painful peripheral neuropathy'], 'conditions': ['Cancer', 'Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': "This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/= 18\n* Diagnosis of cancer\n* Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English (translators will not be used)\n* Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of \\>12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of \\>4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain).\n* Duration of chemotherapy-induced painful peripheral neuropathy \\>4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy.\n* Able to attend research centre according to the required visit schedule.\n* Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)\n* Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.\n\nExclusion Criteria:\n\n* Renal impairment (serum creatinine \\>1.5x normal level)\n* Deranged liver function (AST\\>3x normal level)\n* Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.\n* Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.\n* Pregnancy\n* Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng painful peripheral neuropathy of any other cause.'}, 'identificationModule': {'nctId': 'NCT01278004', 'acronym': 'CINE-E', 'briefTitle': 'Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'CCR3116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Drug', 'interventionNames': ['Drug: Ethosuximide']}], 'interventions': [{'name': 'Ethosuximide', 'type': 'DRUG', 'description': 'Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.', 'armGroupLabels': ['Drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}