A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140 mg AMG 334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments (LIBERTY)
- Conditions
- Migraine10019231
- Registration Number
- NL-OMON50588
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Documented history of migraine (with or without aura) for * 12 months prior
to screening according to the International Classification of Headache
Disorders, 3rd Edition (ICHD-3)
- 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on
average across the 3 months prior to screening based on retrospective reporting
- <15 days per month of headache symptoms (ie migraine and non-migraine)
- Failed 2 to 4 prior migraine prophylaxis treatments out of the following:
Propranolol/metoprolol, topiramate, flunarizine, valproate/divalproex,
amitriptyline, venlafaxine, lisinopril, candesartan, locally approved products
(e.g. oxeterone or pizotifen)
- Failed one AND failed or not be suitable for a second of the following:
* Propranolol OR metoprolol
* Topiramate
* Flunarizine
- Failed or not be suitable to valproate or divalproex
- Older than 50 years of age at migraine onset
- Unable to differentiate migraine from other headaches
- History of cluster headache or hemiplegic migraine headache
- Failed more than 4 prior migraine prophylaxis treatments [as specified in
protocol]
- Use of a prophylactic migraine medication within 5 half-lives, or a device or
procedure within one month prior to the start of the baseline phase or during
the baseline phase
- Prior Botulinum toxin A treatment in the head/neck region (including cosmetic
use or other licensed indications for Botox ®) within 4 months prior to start
of or during the the baseline phase
- Use of the following for any indication in the 1 month prior to the start of
the baseline phase or during the baseline phase:
o ergotamines or triptanes *10 days/month, or
o simple analgesics (NSAIDs, acetaminophen, paracetamol) *15 days/month, or
o opioid- or butalbital-containing analgesics *4 days/month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate the effect of AMG 334<br /><br>compared to placebo on the proportion of patients with at least 50%<br /><br>reduction from baseline in monthly migraine days</p><br>
- Secondary Outcome Measures
Name Time Method