The purpose of this study is to determine the safety and efficacy of AMG 334 compared to placebo in episodic migraine patients who havepreviously failed 2 to 4 prophylactic migraine treatments and therefore have a high unmet medical need.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the effect of AMG 334
compared to placebo on the proportion of patients with at least 50%
reduction from baseline in monthly migraine days
Secondary outcome
Objective 1: To evaluate the effect of AMG 334 compared to placebo on the
change from baseline of monthly migraine days in the last month
(Month 3) of the Double-Blind Treatment Epoch
Objective 2: To evaluate the effect of AMG 334 compared to placebo on the
*impact on everyday activities* sub-domain score as measured by the MPFID on
month 3
Objective 3: To evaluate the effect of AMG 334 compared to placebo on the
*physical impairment* sub-domain score as measured by the MPFID on month 3
Objective 4: To evaluate the effect of AMG 334 compared to placebo on change
from baseline in monthly acute migraine-specific medication
treatment days in the last month (Month 3) of the Double-Blind Treatment Epoch
Objective 5: To evaluate the effect of AMG 334 compared to placebo on the
proportion of patients with at least 75% reduction from baseline in
monthly migraine days in the last month (Month 3) of the Double-Blind Treatment
Epoch
Objective 6: To evaluate the effect of AMG 334 compared to placebo on the
proportion of patients with a 100% reduction from baseline in
monthly migraine days in the last month (Month 3) of the Double-Blind Treatment
Epoch
Objective 7: To evaluate the safety, tolerability, and immunogenicity of AMG
334 during the entire study
Background summary
Migraine is one of the most common neurological disorders with a high global
prevalence,significant socio-economic burden and substantial impairment and
disability of affected patients.Migraineurs are currently being treated for
migraine prophylaxis by a variety of drug classes,
many of them being used off-label and often based on insufficient or limited
evidence.Based on emerging evidence, Calcitonin Gene-related Peptide (CGRP) is
a neuropeptide that prominently contributes to migraine pathophysiology. The
CGRP is an attractive target for the development of a migraine-specific
prophylactic therapy with the aim of minimizing migraine days and improving
patient quality of life in this common and often
disabling disorder. There is a high unmet medical need, in episodic migraine
patients who have previously failed 2-4 prophylactic migraine treatments.
Study objective
The purpose of this study is to determine the safety and efficacy of AMG 334
compared to placebo in episodic migraine patients who have
previously failed 2 to 4 prophylactic migraine treatments and therefore have a
high unmet medical need.
Study design
This study has a 12-week 2-arm, double-blind, randomized, placebo-controlled,
parallel-group design, followed by an optional 156-week open-label epoch
Intervention
AMG334 or placebo
Study burden and risks
When participation part I and II: 46 visits in total , 2 hours per visit, 186
weeks in total.
Physical examination: each visit
ECG: 8x
Subcutaneous injection: 42x (70 ml)
Blood collection: 10x (40-80 ml total)
Women: Pregnancy test: 47x
Completion eDiary: As of first day of treatment till end of study
Completion Questionnaires: 18x
Optional:
1x extra blood collection for pharmacogenetics.
Forbidden co-medication.
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
Medical products/devices used
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Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002211-18-NL |
| ClinicalTrials.gov | NCT03096834 |
| CCMO | NL58509.058.16 |