Prevention of episodic migraine MedDRA version: 20.0 Level: LLT Classification code 10027608 Term: Migraine, unspecified System Organ Class: 100000004852
Conditions
Interventions
Product Name: AMG 334 Vials
Product Code: AMG 334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: erenumab
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults = 18 to = 60 years of age upon entry into screening - History of migraine (with or without aura) for = 12 months prior to screening according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report - Migraine frequency: = 4 and = 14 migraine days per month in each of the 3 months prior to screening - Headache (ie, migraine and non-migraine headache) frequency: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Older than 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine headache - No therapeutic response with > 2 of the eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial ( refer to criterion 4.2.5 in the protocol). - Used a prohibited medication, device or procedure prior to the start of the baseline phase (Refer to Section 6.4 of the protocol for the list of these excluded treatments and the timeframes prior to the start of the baseline phase) - Received botulinum toxin in the head and/or neck region within 6 months prior to the start of the baseline phase - Taken the following for any indication in any month during the 3 months prior to the start of the baseline phase: • Ergotamines or triptans on = 10 days per month, or • Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on = 15 days per month, or • Opioid- or butalbital-containing analgesics on = 3 days per month - History or evidence of unstable or clinically significant medical condition including but not limited to the following: • Chronic pain syndromes (eg, fibromyalgia, chronic back pain, chronic pelvic pain) • History of major psychiatric disorder, or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening. - Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 12 weeks after the last dose of investigational product if receiving AMG 334 70 mg, and 16 weeks after the last dose of investigational product if receiving AMG 334 140 mg. - Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies)
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 episodic 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 episodic migraine • To evaluate the effect of AMG 334 compared to placebo as measured by reduction from baseline in monthly migraine attacks, in subjects with episodic migraine SAFETY To evaluate the safety and tolerability of AMG 334;Primary end point(s): Change in monthly migraine days from baseline in 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 in 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 in monthly migraine attacks from baseline in the last 4 weeks of the 12-week double-blind treatment phase, calculated based on the following: (number of migraine attacks during the last 4 weeks of the double-blind treatment phase, ie, between weeks 9 and 12) – (number of migraine attacks during the 4-week baseline 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, Denmark, Finland, Germany, Norway, Sweden, United States
Contacts
Public ContactMedical Information
Amgen GmbH
Outcome results
None listed