Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 4:40 AM
Study NCT ID:
NCT02301169
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.alvarez@tools4patient.com', 'phone': '+32 71 14', 'title': 'Stephanie Alvarez', 'phoneExt': '02 00', 'organization': 'Tools4Patient'}, 'certainAgreement': {'otherDetails': 'Specific agreement as part of Eureka project', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic", 'otherNumAtRisk': 21, 'otherNumAffected': 7, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic", 'otherNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cervical pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'OG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3748299', 'ciLowerLimit': '-0.5479411', 'ciUpperLimit': '1.2976010', 'pValueComment': 'P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Welch two sample t-test', 'nonInferiorityComment': 'Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo'}], 'paramType': 'MEAN', 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 42', 'description': '11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'OG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1255102', 'ciLowerLimit': '-0.8152493', 'ciUpperLimit': '1.0662697', 'pValueComment': 'P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Welch two sample t-test', 'nonInferiorityComment': 'Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.'}], 'paramType': 'MEAN', 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 42', 'description': '11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'OG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '1.755', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '2.459', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.802381', 'ciLowerLimit': '-0.5457743', 'ciUpperLimit': '2.1505362', 'pValueComment': 'P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Welch two sample t-test', 'nonInferiorityComment': 'Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo'}], 'paramType': 'MEAN', 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': 'IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'OG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '1.003', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '1.502', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06204', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7656429', 'ciLowerLimit': '-0.0406744', 'ciUpperLimit': '1.5719601', 'pValueComment': 'P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Welch two sample t-test', 'nonInferiorityComment': 'Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.'}], 'paramType': 'MEAN', 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': '11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'OG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '5.422', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '5.704', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3386', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.683333', 'ciLowerLimit': '-1.831190', 'ciUpperLimit': '5.197857', 'pValueComment': 'P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Welch two sample t-test', 'nonInferiorityComment': 'Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.'}], 'paramType': 'MEAN', 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': 'Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.\n\nLower values represent a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'FG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T4P1001', 'description': "Heat pain stimuli A\n\nVideo A\n\nAdministration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'BG001', 'title': 'Placebo', 'description': "Heat pain stimuli B\n\nVideo B\n\nAdministration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2014-11-14', 'resultsFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2014-11-21', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment", 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 42', 'description': '11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS'}], 'secondaryOutcomes': [{'measure': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)", 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 42', 'description': '11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS'}, {'measure': "Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)", 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': 'IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.'}, {'measure': "Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period", 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': '11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.'}, {'measure': "Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).", 'timeFrame': 'Time zero equals baseline (Day 1) up to Day 28', 'description': 'Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.\n\nLower values represent a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Peripheral Neuropathies']}, 'descriptionModule': {'briefSummary': "The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women of at least 18 years of age\n* Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive\n* Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months\n* Being affiliated with the national welfare system\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study site\n\nPNP disease diagnosis inclusion criteria:\n\n* Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post-herpetic or post-zooster neuralgia, diabetic polyneuropathy or post-anticancer chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)\n* Pain present since at least 6 months\n* Patients will be required to have a score between 4 and 8 inclusive on the mean Average Pain Score (APS) Numeric Rating Scale (NRS) during the baseline period preceding randomization (data collected in patient diary) and to have completed at least 4 days of pain assessment\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or willing to be pregnant within 2 months\n* With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient\'s participation in the study\n* Uncontrolled epilepsy\n* Any current primary psychiatric condition, including major depression or major personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation)\n* Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine)\n* Acute disease state within 7 days before Visit 2\n* Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient\n* Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link)\n* Patient under legal protection, according to the national law\n* Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to national law\n\nExclusion criteria related to PNP:\n\n* Neuropathic pain due to trigeminal neuralgia, central pain, complex regional pain syndrome and phantom limb pain\n* Plan to have a session of physiotherapy or comportemental therapy such as gestion of pain, hypnosis, sophrology, meditation program during the study\n* Have initiated or have planned an electrical stimulation (or neurostimulation) therapy within 2 weeks prior to Visit 1 or during the study period up to Visit 5\n* Patient changed his/her " regular therapy " in the last 4 months'}, 'identificationModule': {'nctId': 'NCT02301169', 'briefTitle': 'A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tools4Patient'}, 'officialTitle': 'A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain', 'orgStudyIdInfo': {'id': 'T1001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T4P1001', 'interventionNames': ['Behavioral: Heat pain stimuli A', 'Behavioral: Video A', 'Drug: Administration of T4P1001 capsules']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Behavioral: Heat pain stimuli B', 'Behavioral: Video B', 'Drug: Administration of placebo capsules']}], 'interventions': [{'name': 'Heat pain stimuli A', 'type': 'BEHAVIORAL', 'armGroupLabels': ['T4P1001']}, {'name': 'Video A', 'type': 'BEHAVIORAL', 'armGroupLabels': ['T4P1001']}, {'name': 'Administration of T4P1001 capsules', 'type': 'DRUG', 'description': "This treatment is given as add on therapy to patients' regular analgesic", 'armGroupLabels': ['T4P1001']}, {'name': 'Heat pain stimuli B', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Placebo']}, {'name': 'Video B', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Placebo']}, {'name': 'Administration of placebo capsules', 'type': 'DRUG', 'description': "This treatment is given as add on therapy to patients' regular analgesic", 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CIC Clermont-Ferrand, CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Alvaro Pereira', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tools4Patient'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tools4Patient', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}