Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT02115269
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D020326', 'term': 'Migraine without Aura'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008881', 'term': 'Migraine Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jean-pascal.berrou@abbott.com', 'phone': '+41614870457', 'title': 'Jean-Pascal Berrou, Global Medical Director CNS/Pain', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold.\n\nThe most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice', 'otherNumAtRisk': 702, 'otherNumAffected': 16, 'seriousNumAtRisk': 702, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypertension crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consiousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Significant Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting."}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Are Satisfied With IndoProCaf Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 hours post dose', 'description': 'Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting."}, {'type': 'SECONDARY', 'title': 'Time to Significant Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}, {'value': '663', 'groupId': 'OG002'}, {'value': '663', 'groupId': 'OG003'}, {'value': '663', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Significant Pain Reduction at 1 Hour Post Dose', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 1 hour post dose'}, {'id': 'OG001', 'title': 'Significant Pain Reduction at 2 Hours Post Dose', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose'}, {'id': 'OG002', 'title': 'Significant Pain Reduction at 4 Hour Post Dose', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose'}, {'id': 'OG003', 'title': 'Significant Pain Reduction at 6 Hours Post Dose', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose'}, {'id': 'OG004', 'title': 'Significant Pain Reduction at 24 Hours Post Dose', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose'}], 'classes': [{'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting."}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who took second IndoProCaf dose at 2 hours post-dose'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}, {'value': '387', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Primary Headaches and Took Triptans in the Past', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice who took triptans in the past.'}, {'id': 'OG001', 'title': 'Patients With Primary Headaches Who Took NSAIDs and Analgesics', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took NSAIDs and analgesics'}, {'id': 'OG002', 'title': 'Patients Who Took Combined Analgesics', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took combined analgesics in the past'}, {'id': 'OG003', 'title': 'Patients Who Took Ergotamine-based Drugs', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took ergotamine-based drugs in the past'}, {'id': 'OG004', 'title': 'Patients Who Took Antiemetics', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took antiemetics in the past'}, {'id': 'OG005', 'title': 'Patients Who Took Opioid Analgesics', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '29.2', 'groupId': 'OG002'}, {'value': '35.3', 'groupId': 'OG003'}, {'value': '23.5', 'groupId': 'OG004'}, {'value': '27.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '759'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '702'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Did not complete patient diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Moved to another city', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': "Didn't take study drug", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '542', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ukraine', 'categories': [{'measurements': [{'value': '432', 'groupId': 'BG000'}]}]}, {'title': 'Kazakhstan', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety set included all enrolled patients who have taken at least one dose of IndoProCaf'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 759}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-02', 'studyFirstSubmitDate': '2014-04-09', 'resultsFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-04', 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Significant Pain Reduction', 'timeFrame': 'up to 2 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest'}, {'measure': 'Percentage of Patients Who Are Satisfied With IndoProCaf Treatment', 'timeFrame': 'up to 24 hours post dose', 'description': 'Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.'}], 'secondaryOutcomes': [{'measure': 'Time to Significant Pain Reduction', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest'}, {'measure': 'Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response', 'timeFrame': 'up to 2 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest'}, {'measure': 'Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse', 'timeFrame': 'up to 48 hours', 'description': 'significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest'}, {'measure': 'Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack', 'timeFrame': 'baseline', 'description': 'Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Indoprocaf', 'Indomethacin', 'Caffeine', 'Prochlorperazine', 'Migraine with Aura', 'Migraine without Aura', 'Tension-Type Headache'], 'conditions': ['Headache Disorders, Primary', 'Migraine With Aura', 'Migraine Without Aura', 'Tension-Type Headache']}, 'descriptionModule': {'briefSummary': "Headaches are a common medical problem that physicians frequently encounter in their practice. One of key findings of The Atlas of Headache Disorders prepared by World Health Organization (WHO) is: headache disorders, including migraine and tension-type headache (TTH), are among the most prevalent disorders of mankind. The fixed combination of indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is widely used in common daily practice only in Italy from early 1970s, is available at the Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.", 'detailedDescription': 'The study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. No additional procedures (other than the standard of care) shall be applied to the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with migraine (with or without aura) and/or episodic TTH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary headache (migraine with or without aura and/or episodic TTH) and whose headache attacks required acute pharmacological treatment.\n* Were administered IndoProCaf (Difmetre®) effervescent tablets therapy according to the local product labelling.\n* Adults 18 years and older (male, female).\n* Provide Authorization to the investigator to use and/or disclose personal and/or health data.\n\nExclusion Criteria:\n\n* Meet contraindications for treatment with IndoProCaf (Difmetre®) effervescent tablets as outlined in the latest version of local product labelling.\n* Patients who are required prescription by physician of IndoProCaf and nonsteroidal anti-inflammatory drug-containing products at the same time for acute headache attacks treatment.\n* Previous discontinuation of IndoProCaf treatment due to safety (i.e. hypersensitivity) events, lack of efficacy.\n* Female patients who are pregnant or are breast-feeding.'}, 'identificationModule': {'nctId': 'NCT02115269', 'acronym': 'PRESTO', 'briefTitle': "IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "IndoProCaf (Difmetre®) Effervescent Tablets Effectiveness in Acute Treatment of Primary Headaches (Migraine and/or Episodic Tension-type Headache) and Patients' Satisfaction With the Treatment in Routine Clinical Practice in Ukraine and Kazakhstan", 'orgStudyIdInfo': {'id': 'P14-389'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primary headaches', 'description': 'Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '030000', 'city': 'Aktobe', 'country': 'Kazakhstan', 'facility': 'Research facility ID ORG-000986', 'geoPoint': {'lat': 50.27969, 'lon': 57.20718}}, {'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'LLP Medical Centre "Medical Assistance Group"', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Research facility ID ORG-000994', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Research facility ID ORG-000990', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Research facility ID ORG-000991', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Research facility ID ORG-000992', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '10000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'State enterprise on the right of business City Clinic №1', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '100008', 'city': 'Karaganda', 'country': 'Kazakhstan', 'facility': 'LLP "State Center for Primary Health Care"', 'geoPoint': {'lat': 49.80187, 'lon': 73.10211}}, {'zip': '100008', 'city': 'Karaganda', 'country': 'Kazakhstan', 'facility': 'LLP Clinic "Alanda"', 'geoPoint': {'lat': 49.80187, 'lon': 73.10211}}, {'zip': '90005', 'city': 'Karaganda', 'country': 'Kazakhstan', 'facility': 'State enterprise on the right of business City Clinic №2', 'geoPoint': {'lat': 49.80187, 'lon': 73.10211}}, {'zip': '110000', 'city': 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