A Phase 2a Study of AMG 301 in Migraine Prevention

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2017-000630-57-SE
• Date of registration: 30/06/2017
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: A Phase 2a Study of AMG 301 in Migraine Prevention
• Scientific title: A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention.
• Date of first enrolment: 04/07/2017
• Target sample size: 335
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000630-57
• 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, Czech Republic, Denmark, Finland, Germany, Netherlands, Sweden, 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:
PART 1
Subjects are eligible to be included in the baseline period of the study only if all of the following criteria apply:
- Subject has provided informed consent prior to any study-specific activities/procedures being initiated
- Adults = 18 to = 60 years of age at the time of signing the informed consent form.
- History of migraine (with or without aura) for = 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III based on medical records and/or patient self-report.
- Migraine frequency: = 4 migraine days per month on average across the 3 months before screening
- Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy as determined by the investigator, after an adequate therapeutic trial at a dose that is used in the prevention of migraine
- Must meet 1 of the following acute migraine-specific treatment criteria:
1. currently taking triptans or ergotamines as acute migraine treatment (within the last month)
2. had previously responded to triptans or ergotamines but had to discontinue due to intolerance
3. unable to take triptans or ergotamines as acute migraine treatments due to contraindications

PART 2
- Must meet the one of the following migraine criteria:
CM is defined as:
• = 15 headache days of which = 8 headache days meet criteria as migraine days during the baseline period based on the electronic diary (eDiary) calculations
EM is defined as:
• < 15 headache days of which at least 4 or more headache days meet criteria as migraine days during the baseline period based on the eDiary calculations
- Demonstrated at least 80% compliance with the eDiary (for example, completing eDiary items for at least 23 out of 28 days during the baseline period)
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 335
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
PART 1
Subjects are excluded from the study and the baseline period if any of the following criteria apply:
Disease Related
- Older than 50 years of age at migraine onset.
- History of cluster headache, hemiplegic migraine headache
- Unable to differentiate migraine from other headaches
- Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period

Other Medical Conditions
- Currently diagnosed with chronic pain syndromes (eg, fibromyalgia, chronic back pain, chronic pelvic pain)
- History of major psychiatric disorder, (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory II (BDI-II) total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if the investigator considers the subject 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 2 months before the start of the baseline period.
- History of seizure disorder or other significant neurological conditions other than migraine. Note: A single childhood febrile seizure is not exclusionary.
- Malignancy within the 5 years before screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
- Known human immunodeficiency virus infection by history
- Hepatic disease by history or total bilirubin = 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.0 x ULN, as assessed by the central laboratory at screening.
- Glycosylated hemoglobin (HbA1c) = 6.0% at screening
- Serum plasma glucose level = 100 mg/dL at screening; ideally performed while fasting
- History of diabetes mellitus or history of impaired fasting glucose
- Body mass index (BMI) = 18.0 or = 40 at screening
- Poorly controlled hypertension (systolic blood pressure 150 mmHg and/or diastolic blood pressure 90 mmHg or greater)
- Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months before 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 electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
- Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, subject self-report, or positive urine drug test performe

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

Health Condition(s) or Problem(s) studied

Migraine
MedDRA version: 20.0 Level: PT Classification code 10058734 Term: Migraine prophylaxis System Organ Class: 10042613 - Surgical and medical procedures

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

Intervention(s)

Product Name: AMG 301
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: AMG 301
Other descriptive name: AMG 301
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 the baseline period in mean monthly migraine days. The mean monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12 week double blind treatment period.

Secondary Objective: •To evaluate the effect of AMG 301 compared to placebo on the proportion of subjects with at least 50% reduction from the baseline period in monthly migraine days

•To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly acute migraine specific medication treatment days

•To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID)

•To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly impact on everyday activities domain score as measured by the MPFID

•To evaluate the safety and tolerability of AMG 301

Main Objective: To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly migraine days in subjects with migraine

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): •At least a 50% reduction from the baseline period in mean monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period

•Change from the baseline period in monthly acute migraine specific medication days in the last 4 weeks of the 12-week double-blind treatment period.

•Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period

•Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double blind treatment period

Safety
•Adverse events
•Clinical laboratory values and vital signs

Timepoint(s) of evaluation of this end point: Week 12

Secondary ID(s)

NCT03238781

20150308

2017-000630-57-CZ

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date:
Contact: