[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658672":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":45,"studyPopulation":36,"armGroups":46,"interventions":59,"overallOfficials":36,"centralContacts":67,"locations":73,"responsibleParty":89,"collaborators":36,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":36,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":36,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":115,"whyStopped":36,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Migraine Days per 28 Days During Weeks 13 to 16","Migraine days will be measured using a daily diary. A qualifying day contains headache lasting at least 30 minutes with migraine or probable migraine features, or qualifying headache accompanying previously confirmed typical aura. Headache successfully treated with a migraine-specific acute medicine also qualifies, including when shorter than 30 minutes. Aura without headache is excluded. Successful acute treatment means improvement within two hours from moderate or severe pain to mild or no pain, or from mild pain to no pain. Multiple qualifying attacks on one day count once. For periods with at least 23 valid days, counts will be standardized to 28 days. Change is the count during days 85 to 112 minus the prospective baseline count. Negative values indicate improvement.","Baseline, the 28 days before randomization, and weeks 13 to 16 after randomization, days 85 to 112",[14,18,21,25,28,32],{"measure":15,"description":16,"timeFrame":17},"Percentage of Participants With at Least a 50% Reduction in Migraine Days","Percentage of participants whose standardized migraine day count during days 85 to 112 is at least 50% lower than their prospective baseline count. A higher percentage indicates a greater treatment response.","Baseline, the 28 days before randomization, and weeks 13 to 16 after randomization",{"measure":19,"description":20,"timeFrame":17},"Change From Baseline in Acute Headache Medication Days per 28 Days","An acute headache medication day is a day on which at least one medicine is taken to treat headache. Multiple doses or medicines on the same day count once. Counts from periods with at least 23 valid diary days will be standardized to 28 days. Change is the count during days 85 to 112 minus baseline. Negative values indicate reduced acute medication use.",{"measure":22,"description":23,"timeFrame":24},"Change From Baseline in Headache Impact Test Total Score","The six-item Headache Impact Test, HIT-6, measures the impact of headache on daily life. Total scores range from 36 to 78, with higher scores indicating greater headache impact. Change will be calculated as the week 16 score minus the baseline score. Negative values indicate improvement.","Baseline and week 16 after randomization",{"measure":26,"description":27,"timeFrame":24},"Change From Baseline in Migraine Disability Assessment Total Score","The Migraine Disability Assessment, MIDAS, measures headache-related disability during the preceding three months. The total is the sum of five disability items covering work or school, household work, and family, social, or leisure activities. The minimum score is 0, and higher scores indicate greater disability. The total is not normalized to a 0 to 100 scale. Change will be calculated as the week 16 score minus the baseline score. Negative values indicate improvement.",{"measure":29,"description":30,"timeFrame":31},"Percentage of Participants Discontinuing Assigned Treatment Because of an Adverse Event","Percentage of participants who permanently discontinue their assigned study medicine because of an adverse event during the randomized treatment period. Medication discontinuation will be distinguished from withdrawal from outcome follow-up.","From the first study dose through day 112 after randomization",{"measure":33,"description":34,"timeFrame":35},"Percentage of Participants With Treatment-Emergent Adverse Events","Percentage of participants experiencing at least one new medical event or worsening of a pre-existing event after starting study medication, regardless of its assessed relationship to treatment. Events will be assessed for severity, seriousness, relationship to treatment, and outcome.","From the first study dose through day 140 after randomization",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"SINGLE",[44],"PARTICIPANT","This investigator-initiated, single-centre, randomized, blinded, active-comparator, parallel-group superiority trial will compare nortriptyline with amitriptyline for the preventive treatment of episodic migraine at Sultan Qaboos University Hospital, Muscat, Oman.\n\nAdults aged 18 to 65 years with migraine with or without aura will be screened. Eligibility requires a history consistent with episodic migraine and a prospective 28-day baseline showing 4 to 14 migraine days and fewer than 15 headache days, with at least 23 valid diary days.\n\nNinety participants will be randomized in a 1:1 ratio. An independent statistician will generate an unstratified allocation sequence using randomly varying balanced permuted blocks. Allocation will be concealed through a pharmacy-controlled system. Participants, care providers, investigators, and outcome assessors will remain masked. Pharmacy personnel preparing the medicines and the statistician generating the allocation sequence will be unmasked.\n\nThe medicines will be supplied in matching coded capsules containing 10 mg of the assigned medicine. The planned dose is 10 mg nightly during week 1, 20 mg during week 2, 30 mg during week 3, and 40 mg during week 4. The target from week 5 is 50 mg nightly when tolerated. Lower maintenance doses, temporary holds, reductions, or discontinuation are permitted for documented safety or tolerability reasons. Early subjective improvement alone will not determine a lower target during scheduled titration. Participants may decline escalation or stop treatment while continuing outcome follow-up.\n\nThe final tolerated maintenance dose will be documented by week 6, with no routine escalation after day 42. Equal numerical doses are not assumed to be pharmacologically equivalent. The trial compares these specified treatment strategies.\n\nThe randomized treatment period is 16 weeks. Randomization defines study day 1, and delayed treatment initiation or visits will not shift outcome windows. The primary endpoint period is days 85 to 112. Treatment will normally be tapered over the following two weeks, with a safety assessment at week 20. Appropriate ongoing migraine care will be arranged.\n\nThe primary outcome is change from baseline in migraine days per 28 days during weeks 13 to 16. Secondary outcomes include the proportion achieving at least a 50% reduction in migraine days, changes in headache days and acute headache medication days, Headache Impact Test scores, Migraine Disability Assessment scores, treatment discontinuation because of adverse events, adverse events, serious adverse events, and body weight.\n\nSafety procedures include clinical assessment, electrocardiograms, relevant laboratory tests, medication interaction review, pregnancy testing where applicable, and psychiatric risk assessment. An independent safety physician will review emerging safety information.\n\nThe sample size uses planning assumptions of a between-group difference of 2 migraine days per 28 days, a standard deviation of 3 days, 80% power, and a two-sided significance level of 0.05. Approximately 37 evaluable participants per group are required. Allowance for approximately 15% unavailable primary outcomes and rounding gives a target of 90 randomized participants.\n\nThe primary analysis will follow the intention-to-treat principle and use analysis of covariance adjusted for baseline migraine days. The adjusted between-group difference will be reported with a 95% confidence interval. Missing outcomes will be addressed using prespecified multiple imputation and sensitivity analyses. Secondary analyses will be exploratory. A nonsignificant difference will not establish equivalence or noninferiority.\n\nEthical approval will be sought from the Medical Research Ethics Committee, College of Medicine and Health Sciences, Sultan Qaboos University. Recruitment will begin only after ethics approval and other required institutional and regulatory permissions are obtained.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Nortriptyline","EXPERIMENTAL","Participants will receive oral nortriptyline each evening for 16 weeks. The planned dose is 10 mg nightly in week 1, 20 mg in week 2, 30 mg in week 3, and 40 mg in week 4, followed by a target of 50 mg nightly from week 5 when tolerated. Lower doses and treatment interruptions are permitted for safety or tolerability. The final maintenance dose will be documented by week 6, with no routine escalation after day 42. Treatment will normally be tapered after week 16, with safety follow-up at week 20.",[52],"Drug: Nortriptyline",{"label":54,"type":55,"description":56,"interventionNames":57},"Amitriptyline","ACTIVE_COMPARATOR","Participants will receive oral amitriptyline each evening for 16 weeks. The planned dose is 10 mg nightly in week 1, 20 mg in week 2, 30 mg in week 3, and 40 mg in week 4, followed by a target of 50 mg nightly from week 5 when tolerated. Lower doses and treatment interruptions are permitted for safety or tolerability. The final maintenance dose will be documented by week 6, with no routine escalation after day 42. Treatment will normally be tapered after week 16, with safety follow-up at week 20.",[58],"Drug: Amitriptyline",[60,64],{"type":61,"name":48,"description":62,"armGroupLabels":63,"otherNames":36},"DRUG","Oral nortriptyline supplied in matching coded 10 mg capsules. Participants will take one to five capsules nightly according to the prescribed schedule, starting at 10 mg and increasing no more frequently than weekly toward 50 mg when tolerated. Dose adjustments will follow prespecified safety and tolerability rules. The randomized treatment period is 16 weeks, normally followed by an individualized taper over approximately two weeks.",[48],{"type":61,"name":54,"description":65,"armGroupLabels":66,"otherNames":36},"Oral amitriptyline supplied in matching coded 10 mg capsules. Participants will take one to five capsules nightly according to the prescribed schedule, starting at 10 mg and increasing no more frequently than weekly toward 50 mg when tolerated. Dose adjustments will follow prespecified safety and tolerability rules. The randomized treatment period is 16 weeks, normally followed by an individualized taper over approximately two weeks.",[54],[68],{"name":69,"role":70,"phone":71,"phoneExt":36,"email":72},"Mohammed Al.Alawi, MD, PhD, MBA, MRCPsych UK","CONTACT","96824141511","m.alalawi2@squ.edu.om",[74],{"facility":75,"status":36,"city":76,"state":36,"zip":36,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Sultan Qaboos University Hospital, University Medical City","Muscat","Oman","OM",{"type":80,"coordinates":81},"Point",[82,83],58.40778,23.58413,{"lat":83,"lon":82},[86],{"name":87,"role":70,"phone":88,"phoneExt":36,"email":72},"Mohammed Al.Alawi","24 147777",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Mohammed Al Alawi MD PhD MRCPsych ARABpsych OMSBpsych","Assistant Professor","100658672","phase-4-nortriptyline-compared-with-amitriptyline-for-migraine-prevention-at-squh-100658672",false,"NCT07856056","Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUH","A Randomized Double Blind Parallel Group Trial Comparing Nortriptyline With Amitriptyline for the Preventive Treatment of Episodic Migraine in Adults at Sultan Qaboos University Hospital","Inclusion Criteria:\n\n1. Age 18 to 65 years at consent, of any sex or nationality, receiving care at Sultan Qaboos University Hospital and able to attend the required visits.\n2. Migraine with or without aura diagnosed according to the International Classification of Headache Disorders, third edition, present for at least 12 months, with onset before age 50 years.\n3. A history consistent with episodic migraine during the preceding three months and a prospective baseline showing 4.0 to 14.0 migraine days inclusive and fewer than 15 headache days per 28 days.\n4. A clinical indication for preventive therapy agreed by the treating clinician and participant.\n5. At least 23 valid diary days during the prospective 28-day baseline. Frequency thresholds will be assessed using standardized 28-day counts without rounding.\n6. Ability to provide informed consent and complete an Arabic or English diary independently or with approved assistance that records the participant's own responses.\n7. For participants who could become pregnant, a negative pregnancy test and agreement to an effective contraceptive approach or consistent abstinence where this reflects usual practice, from consent until 30 days after the last study dose.\n\nExclusion Criteria:\n\n1. Chronic migraine, another predominant headache disorder, suspected secondary headache, a trigeminal autonomic cephalalgia, or inability to distinguish migraine from other recurrent head pain. Hemiplegic migraine and migraine with brainstem aura are excluded. Typical visual or sensory aura is eligible.\n2. Medication overuse headache or sustained acute medication use at overuse thresholds during the preceding three months. Use on 10 or more days per month of triptans, ergots, opioids, combination analgesics, or mixed acute drug classes, or on 15 or more days per month of simple analgesics or nonsteroidal anti-inflammatory drugs, will exclude participation. Baseline diary use meeting these thresholds will also exclude participation.\n3. Previous clear treatment failure after an adequate course of either trial medicine, or previous clinically important intolerance, allergy, or contraindication to either medicine or its excipients. An adequate course is at least eight weeks at a tolerated dose of at least 25 mg nightly with insufficient benefit. Brief previous exposure without established failure is permissible if completed at least three months before screening and recorded.\n4. Current migraine preventive medication or another treatment with substantial preventive activity that cannot safely be stopped. Oral preventive medicines must have been discontinued for at least four weeks and at least five elimination half-lives, whichever is longer, before baseline. OnabotulinumtoxinA or peripheral nerve blocks for prevention within four months, or a calcitonin gene-related peptide monoclonal antibody within six months or five half-lives, whichever is longer, will exclude participation. Preventive gepants follow the oral preventive washout rule. Effective treatment will not be withdrawn solely to enable enrollment when clinically inappropriate.\n5. Current use of another antidepressant, a monoamine oxidase inhibitor, or a clinically important interacting medicine that cannot safely be avoided. All prescribed, nonprescribed, and herbal products will undergo pharmacist review. A prior monoamine oxidase inhibitor requires at least a 14-day interval, with any longer product-specific interval respected. Recent fluoxetine or another long-acting inhibitor requires an individualized documented washout. Psychiatric treatment will not be withdrawn simply to meet trial eligibility.\n6. Previous myocardial infarction with ongoing risk, clinically significant ischemic or structural heart disease, heart failure, clinically important arrhythmia, unexplained syncope, congenital long QT syndrome, Brugada syndrome, or a family history suggesting an inherited arrhythmia without satisfactory specialist assessment.\n7. Baseline corrected QT interval using Fridericia's formula above 450 milliseconds in men or 470 milliseconds in women, QRS duration of 120 milliseconds or greater, any degree of atrioventricular block including PR above 200 milliseconds, or another clinically significant electrocardiographic abnormality. A borderline or technically inadequate trace may be repeated and reviewed before eligibility is determined.\n8. Uncontrolled epilepsy, previous serious drug-related seizure, untreated narrow-angle glaucoma, clinically important urinary retention, paralytic ileus, untreated hyperthyroidism, or a comparable condition increasing tricyclic treatment risk.\n9. Severe hepatic disease, estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m², or clinically significant uncorrected electrolyte disturbance. Alanine aminotransferase or aspartate aminotransferase above three times the local upper limit, or bilirubin above twice the upper limit unless a documented benign cause exists, requires exclusion or specialist clarification before reconsideration.\n10. Bipolar I or II disorder, previous antidepressant-induced mania or hypomania, current psychosis, current suicidal intent or plan, a suicide attempt within the preceding year, or another psychiatric condition requiring treatment incompatible with the protocol. Stable anxiety or mild depressive symptoms alone will not exclude participation.\n11. Current moderate or severe substance use disorder likely to affect safety or reliable participation.\n12. Pregnancy, breastfeeding, planned pregnancy during participation, or inability to follow the agreed pregnancy prevention arrangements.\n13. Participation in another interventional trial within the preceding 30 days or five investigational drug half-lives, whichever is longer.\n14. A condition, planned procedure, or practical limitation preventing informed consent, reliable outcome assessment, or safe completion, with a specific reason documented by the investigator.","ALL","18 Years","65 Years",{"count":104,"type":105},90,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","This study will compare nortriptyline and amitriptyline for preventing migraine attacks in adults receiving care at Sultan Qaboos University Hospital in Oman. The researchers will assess whether the medicines differ in their effect on migraine frequency, side effects, and continued treatment use.\n\nNinety adults with episodic migraine will be assigned by chance to receive either nortriptyline or amitriptyline, with 45 participants in each group. After completing a four-week baseline headache diary, participants will take the assigned medicine each evening for 16 weeks. Treatment will start at 10 mg nightly and increase gradually toward 50 mg nightly when tolerated. Lower doses will be permitted for safety or tolerability reasons. Participants and the clinical assessment team will not know which medicine has been assigned.\n\nThe main outcome will be the change in migraine days during the final four weeks of treatment compared with baseline. Other outcomes will include headache days, use of medicines for acute headache, headache impact, migraine-related disability, adverse events, and stopping treatment because of adverse events.\n\nTreatment will usually be tapered over two weeks, with a final safety assessment at week 20 after randomization. Participation will last approximately 24 weeks, including the baseline period. Appropriate acute migraine treatment will remain available throughout the study.",[111],"Migraine",[113,114,48,54],"Episodic migraine","Migraine prevention","NOT_YET_RECRUITING","2026-09-27",{"date":118,"type":119},"2026-10-02","ACTUAL",{"date":121,"type":105},"2027-05",{"date":123,"type":105},"2030-12",{"name":5,"class":6},1]