A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures1a
CONQUER was a Phase 3 study with a 3-month, double-blind phase1:
- Enrolled 462 adult patients with episodic migraine (58%) or chronic migraine (42%)
- Eligible patients were 18-75 years of age
- Patients had a history of 2-4 standard-of-care preventive category failuresa
- The prior preventive categories were propranolol or metoprolol, topiramate, valproate or divalproex, amitriptyline, flunarizine, candesartan, and botulinum toxin A or B (if taken for chronic migraine)
- Of the patients enrolled, about 58% had 2 preventive treatment failures, 30% had 3 preventive treatment failures, and 10% had 4 preventive treatment failures in the previous 10 years
aFailure was defined as discontinuation over the previous 10 years due to inadequate efficacy (after at least 2 months at maximum tolerated dose) or safety/tolerability reasons, or both.1
Double-blind treatment phase1
-
3-month randomized, double-blind phase (N=462)
- Patients were randomized to receive once-monthly placebo or Emgality 120 mg, after an initial loading dose of 240 mg
The primary endpoint during the double-blind phase was1:
- LS mean change from baseline in the number of monthly MHDs in the total population (episodic and chronic) over Months 1 to 3
Key secondary endpoints during the double-blind phase were1:
- Mean percentage of patients with ≥50% reduction from baseline in the number of monthly MHDs over Months 1 to 3
- Mean percentage of patients with ≥75% reduction from baseline in the number of monthly MHDs over Months 1 to 3
- Mean percentage of patients with 100% reduction from baseline in the number of monthly MHDs over Months 1 to 3
- Mean change from baseline in the MSQ v2.1 RF-R score at Month 3
Another secondary endpoint was3:
- Mean change from baseline in MIBS-4 scores at Month 3
The study excluded patients with1:
- A lifetime history of cluster headache or migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and migraine with brainstem aura
- History of head or neck injury within 6 months before screening
- History of traumatic head injury associated with significant change in the quality or frequency of headaches
- Presence of acute cardiovascular events or serious cardiovascular risk, or both, based on ECG results during the screening visit
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months before screening
- Hepatic disease based on liver tests
- Serious or unstable medical or psychiatric condition
ECG=electrocardiogram; LS=least-square; MHD=migraine headache day; MIBS-4=Migraine Interictal Burden Scale-4; MSQ v2.1=Migraine-Specific Quality of Life version 2.1; RF-R=Role Function-Restrictive.