Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT06357260
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.\n\ncontrol group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': '0-8 weeks', 'description': '0- no pain 10-worst pain possible .Higher score means worst outcome'}, {'measure': 'Brief pain inventory', 'timeFrame': '0-8 weeks', 'description': '1-4=mild pain. 07-10 =severe pain. Higher score means worst outcome'}], 'secondaryOutcomes': [{'measure': 'Mean dose of carbamazepine', 'timeFrame': '0-8 weeks', 'description': 'lower dose requirement of carbamazepine means better outcome'}, {'measure': 'Patient global impression of scale', 'timeFrame': '0-8 weeks', 'description': '1- very much improved and 7-very much worse .Higher score means worst outcome'}, {'measure': 'Liverpool scale', 'timeFrame': '0-8 weeks', 'description': 'Scale meant for adverse events score ranging from 19 -76 with higher score indicating greater adverse event related to drug'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': 'Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated.', 'detailedDescription': "AIM\n\nEvaluation of Efficacy of Pregabalin as an add on therapy with Carbamazepine in patients with trigeminal neuralgia.\n\nOBJECTIVES\n\nPrimary objectives-\n\n1\\. To compare the change in pain intensity in both groups.\n\nSecondary objectives-\n\n1. To evaluate the mean dose of carbamazepine used in both the groups.\n2. To evaluate quality of life.\n3. To evaluate the patient satisfaction in both groups.\n4. To evaluate the need for additional pain medicine in both groups.\n\nSTUDY DESIGN\n\nA randomized clinical trial will be conducted in department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.\n\nSTUDY SETTING\n\nHospital based study - Patients diagnosed with Trigeminal neuralgia will be recruited in study from regular OPD of the department of Oral Medicine and Radiology.\n\nSTUDY PERIOD\n\nThis study will be completed in 1 year.\n\nSTUDY SUBJECTS\n\nPatients diagnosed with classical Trigeminal neuralgia will be recruited in the study from regular OPD of the Department of Oral Medicine and Radiology, PGIDS, Rohtak, Haryana. A total of 50 patients would compromise; Test group (n=25) and Control group (n=25).\n\nMETHOD OF RECRUITMENT Patient will be randomly allocated to test and control groups by using simple random sampling.\n\nINTERVENTION\n\nClinically and MRI proven cases of classical Trigeminal neuralgia will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups.\n\nTEST GROUP\n\nTest group will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.\n\nCONTROL GROUP\n\nIn control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.\n\nBoth groups will be assessed for the following parameters: intensity of pain, at the baseline ,1st week, 2nd week, 4th week ,6th week and 8th weeks interval."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n* Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II.\n* Patient's consent for participation in this study.\n\nEXCLUSION CRITERIA\n\n* Pregnant and lactating women\n* Patients on anti-depressants like sodium valproate\n* History of excessive alcohol intake\n* Hepatic or renal insufficiency\n* Known tolerance/allergy to study drug\n* Non -compliant during screening period\n* Any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity)"}, 'identificationModule': {'nctId': 'NCT06357260', 'briefTitle': 'Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Shifa OMR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group-1', 'description': "Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need", 'interventionNames': ['Drug: Pregabalin and Carbamazepine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "Carbamazepine with dose of Carbamazepine being titrated as per patients's need", 'interventionNames': ['Drug: Carbamazepine']}], 'interventions': [{'name': 'Pregabalin and Carbamazepine', 'type': 'DRUG', 'otherNames': ['Test group'], 'description': "Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need", 'armGroupLabels': ['Test group-1']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': "Carbamazepine with dose of Carbazmaepine being titrated as per patients's need", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'DR. Lavina Arya, MDS', 'role': 'CONTACT', 'email': 'aryalavina@gmail.com', 'phone': '09212795285'}, {'name': 'Dr. Ambika Gupta, MDS', 'role': 'CONTACT', 'email': 'drambika79@rediffmail.com', 'phone': '09315903300'}, {'name': 'Shifa Akhtar, MDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PGIDS', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'Sanjay Tewari, MDS', 'role': 'CONTACT', 'email': 'principalpgids@gmail.com', 'phone': '09416259534'}], 'overallOfficials': [{'name': 'Shifa Akhtar, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Dental Sciences ,Rohtak'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}