A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

Novartis

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Biological: Placebo Pre-Filled Syringe (PFS); Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03096834

CAMG334A2301

2016-002211-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

Full description

This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.

Enrollment: 246 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of migraine in the 12 months prior to screen
• 4-14 days per month of migraine symptoms
• >=80% diary compliance during the Baseline period
• Failure of previous migraine prophylactic treatments

Exclusion criteria

• >50 years old at migraine onset
• Pregnant or nursing
• History of cluster or hemiplegic headache
• Evidence of seizure or psychiatric disorder
• Score of over 19 on Beck Depression Inventory-2
• Active chronic pain syndrome
• Cardiac or hepatic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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246 participants in 4 patient groups, including a placebo group

Placebo DB

Placebo Comparator group

Description:

Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

Treatment:

Biological: Placebo Pre-Filled Syringe (PFS)

AMG334 140 mg DB

Experimental group

Description:

AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch

Treatment:

Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)

AMG334 140 mg DB cont on AMG334 140 mg

Experimental group

Description:

AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch

Treatment:

Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)

Placebo in DB to AMG334 140 mg

Experimental group

Description:

Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch

Treatment:

Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)