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

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2012-005331-90-SE
• Date of registration: 03/05/2013
• 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 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
• Date of first enrolment: 04/09/2013
• Target sample size: 468
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005331-90
• 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: yes; Other trial design description: placebo-controlled period followed by open label period (see protocol for further details); If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Denmark, Finland, Germany, Norway, 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:
- 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: < 15 headache days per month (with = 50% of the headache days being migraine days) 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 468
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
- 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)


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

Health Condition(s) or Problem(s) studied

Prevention of episodic migraine
MedDRA version: 20.0 Level: LLT Classification code 10027608 Term: Migraine, unspecified System Organ Class: 100000004852

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

Intervention(s)

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 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

Product Name: AMG 334
Product Code: AMG 334
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: erenumab
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-

Primary Outcome(s)

Primary end point(s): Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase.

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

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 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
• 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

Secondary ID(s)

20120178

2012-005331-90-DE

NCT01952574

Source(s) of Monetary Support

Amgen Inc

Ethics review

Status: Approved
Approval date: 04/09/2013
Contact:

Results

• Results available: Yes
• Date Posted: 26/11/2020
• Date Completed: 12/11/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005331-90/results