Prevention of chronic migraine MedDRA version: 19.0 Level: LLT Classification code 10027608 Term: Migraine, unspecified System Organ Class: 100000004852
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults = 18 to = 65 years of age upon entry into screening - History of at least 5 attacks of migraine without aura and/or migraine with visual, sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self-report - History of = 15 headache days per month of which = 8 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 622 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: - Older than 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine headache - Chronic migraine with continuous pain, in which the subject does not experience any pain free periods (of any duration) during the 1 month prior to screening - Taken an opioid and/or opioid-containing analgesic for any indication on greater than 12 days during the 3 months prior to screening - Taken a butalbital-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening - No therapeutic response in prophylaxis of migraine after an adequate therapeutic trial to > 3 of the medication categories (detailled in the protocol) - Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase (Refer to Section 6.5 for the list of excluded medications, devices and procedures) - Changing the dose of a concomitant medication that is not prescribed for migraine prophylaxis but that may have migraine prophylaxis effects within 1 month prior to screening. (Refer to Section 6.4 and Section 6.5 for the list of these medications) - Received botulinum toxin in the head and/or neck region within 4 months prior to Screening - History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. - Excluded medical conditions include but not limited to: · Currently diagnosed with fibromyalgia, and/or chronic pelvic pain · History of major psychiatric disorder (such as schizophrenia or other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening. · History of seizure disorder or other significant neurological conditions other than migraine · Poorly controlled hypertension in the judgment of the investigator, or systolic blood pressure (BP) = 160 mm Hg or diastolic BP = 100 mm Hg as measured at the screening or week -4 study visits · Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening - Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 16 weeks after the last dose of investigational product. - Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(-ies), or previous discontinuation from another drug study due to a serious adverse event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with chronic migraine;Secondary Objective: Efficacy: • To evaluate the effect of AMG 334, compared to placebo, on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days, in subjects with chronic migraine • To evaluate the effect of AMG 334, compared to placebo, as measured by the change from baseline on monthly migraine-specific medication treatment usage • To evaluate the effect of AMG 334 compared to placebo as measured by change from baseline on monthly cumulative hours of headache Safety: To evaluate the safety and tolerability of AMG 334;Primary end point(s): Change in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase;Timepoint(s) of evaluation of this end point: Change in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase, calculated based on the following: (number of migraine days during the last 4 weeks of the double-blind treatment phase, ie, between weeks 9 and 12) - (number of migraine days during the 4-week baseline phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • At least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment phase • Change from baseline on monthly migraine-specific medication treatment days in the last 4 weeks of the 12-week double-blind treatment phase •Change from baseline in cumulative monthly headache hours in the last 4 weeks of the 12-week double-blind treatment phase Safety: • Adverse events • Clinical laboratory values and vital signs • Anti-AMG 334 antibodies;Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol. | — |
Countries
Canada, Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed