Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-11 @ 1:16 PM
Study NCT ID:
NCT00527202
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2007-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Botox to Treat Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2007-09-07', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported pain (numerical scales) on patients diaries', 'timeFrame': 'prospective', 'description': 'pain intensity on numerical rating scales'}], 'secondaryOutcomes': [{'measure': 'mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness', 'timeFrame': 'prospective', 'description': 'VAS for pain intensity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postherpetic Neuralgia', 'Nerve Trauma']}, 'descriptionModule': {'briefSummary': 'Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)', 'detailedDescription': 'The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion\n* limited area of pain\n* mechanical allodynia in the painful area\n\nExclusion Criteria:\n\n* contraindication to BTXA formulation\n* coagulation disorders\n* another painful condition\n* current major depression\n* history of drug or alcohol abuse\n* compensation claim or litigation\n* facial neuropathic pain'}, 'identificationModule': {'nctId': 'NCT00527202', 'briefTitle': 'Efficacy Study of Botox to Treat Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Ambroise Paré Paris'}, 'officialTitle': 'Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia', 'orgStudyIdInfo': {'id': 'BTXneurop-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin A', 'description': 'active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart', 'interventionNames': ['Drug: botulinum toxin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'saline injection with the same dosages injected using the same procedure as botulinum toxin A', 'interventionNames': ['Drug: botulinum toxin A']}], 'interventions': [{'name': 'botulinum toxin A', 'type': 'DRUG', 'otherNames': ['saline (placebo)'], 'description': 'Botulinum toxin A versus saline in parallel groups', 'armGroupLabels': ['botulinum toxin A', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100f', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hôpital Ambroise Paré, AP-HP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'overallOfficials': [{'name': 'Didier BOUHASSIRA, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSERM U 792'}, {'name': 'Danièle RANOUX, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'hôpital de Limoges (FRANCE)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Ambroise Paré Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD coordinator', 'investigatorFullName': 'Nadine ATTAL', 'investigatorAffiliation': 'Hospital Ambroise Paré Paris'}}}}