Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients (EMPOwER)

Novartis

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Biological: Erenumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03333109

CAMG334A2302

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

Full description

This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Enrollment: 900 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

1. Documented history of migraine in the 12 months prior to screening
2. 4-14 days per month of migraine symptoms
3. >=80% diary compliance during the Baseline period

Key exclusion criteria:

1. >50 years old at migraine onset
2. Pregnant or nursing
3. History of cluster or hemiplegic headache
4. Evidence of seizure or major psychiatric disorder
5. Score of 19 or higher on the BDI
6. Active chronic pain syndrome
7. Cardiac or hepatic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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900 participants in 3 patient groups, including a placebo group

AMG334 70 mg

Experimental group

Description:

AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days

Treatment:

Biological: Erenumab

AMG334 140 mg

Experimental group

Description:

AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days

Treatment:

Biological: Erenumab

Placebo

Placebo Comparator group

Description:

Two pre-filled syringes containing placebo identical in appearance to erenumab

Treatment:

Other: Placebo