A Study of the Effects of AMG 334 to Prevent Migraine Headaches

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2014-004464-38-FI
• Date of registration: 27/05/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: A Study of the Effects of AMG 334 to Prevent Migraine Headaches
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention - STRIVE study
• Date of first enrolment: 25/06/2015
• Target sample size: 955
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004464-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Czech Republic, Finland, Germany, Hungary, Netherlands, Poland, Slovakia, Sweden, Turkey, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Criteria to be assessed prior to entering the subject into the initial screening phase and/or baseline phase:
•Adults = 18 to = 65 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-3 based on medical records and/or patient self-report
• Migraine frequency: = 4 and < 15 migraine days per month on average across the 3 months prior to screening
• Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening

Criteria to be assessed during the baseline phase and confirmed prior to randomizing the subject into the double-blind treatment phase:
• Migraine frequency: = 4 and < 15 migraine days during the baseline phase based on the eDiary calculations
• Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations
• Demonstrated at least 80% compliance with the eDiary
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 955
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Older than 50 years of age at migraine onset
• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers
- Category 4: Tricyclic antidepressants
- Category 5: Serotonin-norepinephrine reuptake inhibitors
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
• Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
• Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase
• Taken the following for any indication in any month during the 2 months prior to the start of the baseline phase:
- Ergotamines or triptans on = 10 days per month, or
- Simple analgesics on = 15 days per month, or
- Opioid- or butalbital-containing analgesics on = 4 days per month
• Anticipated to require any excluded medication, device, or procedure during the study
• Active chronic pain syndromes
• History of major psychiatric disorder, or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable (with BDI-II = 19) and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline phase.
• History of seizure disorder or other significant neurological conditions other than migraine.
• Malignancy within the 5 years prior to screening, except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ
• Human immunodeficiency virus (HIV) infection by history
• Hepatic disease by history or total bilirubin = 2.0 x ULN or alanine transaminase (ALT) or aspartate aminotransferase (AST) = 3.0 x ULN, as assessed by the central laboratory at initial screening
• Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
• History or evidence of any other 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
• Subject has any clinically significant vital sign, laboratory, or ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
• The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening
• Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records, patient self-report, or positive urine drug test performed during screening
• Pregnant or breastfeeding, or is a female expecting to conceive or breastfeed during the study, including through 16 weeks after the last dose of investigational

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Migraine Prevention
MedDRA version: 19.1 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: AMG 334
Product Code: AMG 334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not applicable
CAS Number: 1582205-90-0
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Change from baseline in mean monthly migraine days. The mean monthly migraine days will be calculated using the monthly migraine days from each of the last three months (months 4, 5, and 6) of the double-blind treatment phase.

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 mean monthly migraine days
• To evaluate the effect of AMG 334 compared to placebo on the change from baseline in mean monthly acute migraine-specific medication treatment days
• To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least a 5-point reduction from baseline in mean impact on everyday activities domain score as measured by the Migraine Physical Function Impact Diary (MPFID)
• To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least a 5-point reduction from baseline in mean physical impairment domain score as measured by the MPFID
Safety: To evaluate the safety and tolerability of AMG 334

Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.

Main Objective: To evaluate the effect of AMG 334 compared to placebo on the change from baseline in mean monthly migraine days, in subjects with episodic migraine

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.

Secondary end point(s): Efficacy:
• Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase
• Change from baseline in mean monthly acute migraine-specific medication treatment days over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase
• Achievement of at least a 5-point reduction from baseline in mean impact on everyday activities domain score over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase as measured by the MPFID
• Achievement of at least a 5-point reduction from baseline in mean physical impairment domain score over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase as measured by the MPFID.
Safety:
• Adverse events
• Clinical laboratory values and vital signs
• Anti-AMG 334 antibodies

Secondary ID(s)

20120296

Source(s) of Monetary Support

Amgen Inc