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Nortriptyline vs Amitriptyline for Preventive Treatment of Episodic Migraine
NCT07856056Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- May 2027
- Primary completion
- May 2030
- Countries
- 1
- Sponsor
- Sultan Qaboos University
- Drugs
- nortriptyline
- Conditions
- episodic migraine
01
Overview
Phase 4, randomised, double-blind trial of nortriptyline in episodic migraine (2 arms), sponsored by Sultan Qaboos University. Primary endpoint: Change From Baseline in Migraine Days per 28 Days. Planned start May 2027; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nortriptyline
Oral nortriptyline each evening for 16 weeks
Amitriptyline
Oral amitriptyline each evening for 16 weeks
03
Who it enrols
Adults aged 18-65 with episodic migraine (4-14 migraine days/month), excluding those with chronic migraine, medication overuse headache, severe psychiatric or cardiac conditions, or recent use of other preventive migraine medications.
04
Endpoints
Primary
Change From Baseline in Migraine Days per 28 Days
Secondary
Percentage of Participants With at Least a 50% Reduction in Migraine Days
Change From Baseline in Acute Headache Medication Days per 28 Days
Change From Baseline in Headache Impact Test Total Score
Change From Baseline in Migraine Disability Assessment Total Score
Percentage of Participants Discontinuing Assigned Treatment Because of an Adverse Event
Percentage of Participants With Treatment-Emergent Adverse Events
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