Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUH
ConditionMigraine
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSultan Qaboos University
About this trial
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.
Ninety 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.
The 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.
Treatment 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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.
A clinical indication for preventive therapy agreed by the treating clinician and participant.
Disqualifiers
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.
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.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nortriptyline
DrugOral 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.
Amitriptyline
DrugOral 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: NortriptylineExperimental treatment 1 intervention
Group B: AmitriptylineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, the 28 days before randomization, and weeks 13 to 16 after randomization, days 85 to 112Secondary outcomes
1
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.
Time frame
Baseline, the 28 days before randomization, and weeks 13 to 16 after randomization2
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.
Time frame
Baseline, the 28 days before randomization, and weeks 13 to 16 after randomization3
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.
Time frame
Baseline and week 16 after randomization4
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.
Time frame
Baseline and week 16 after randomizationSponsors and contacts
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Source ClinicalTrials.gov
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