The purpose of this study is to determine the sustained benefit on safety and efficacy of AMG 334 compared to oral prophylactics in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments and therefore have a…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to demonstrate the superiority of subcutaneous
erenumab compared to oral prophylactic(s) on sustained benefit defined as %
subjects completing one-year on the randomized treatment and achieving at least
a 50% reduction from baseline in monthly migraine days at month 12.
Secondary outcome
The secondary objectives are the following:
Objective 1: To evaluate the effect of erenumab compared to oral
prophylactic(s) on overall subject retention defined as % subjects completing
study on randomized treatment
Objective 2: To evaluate the effect of erenumab compared to oral
prophylactic(s) on the change from baseline in monthly migraine days during the
treatment period
Objective 3: To evaluate the effect of erenumab compared to oral
prophylactic(s) on the subject's assessment of the change in clinical status
since the start of treatment as measured by the Patients' Global Impression of
Change (PGIC) Scale
Background summary
The purpose of this study is to compare the sustained long-term benefit between
two treatment paradigms of migraine prophylactic agents (erenumab versus a
control arm of oral prophylactics) in episodic migraine patients who have
previously failed 1 to 2 prophylactic migraine treatments. Data from this
study, in addition to the data generated thus far in the clinical program, will
provide important data for clinicians treating migraine patients, particularly
for patients who have previously failed existing preventative treatments, as
there are limited treatment options. Subsequently it will determine if early
use of erenumab during a treatment algorithm is associated with a favorable
long-term sustained benefit.
Study objective
The purpose of this study is to determine the sustained benefit on safety and
efficacy of AMG 334 compared to oral prophylactics in episodic migraine
patients who have previously failed 1 to 2 prophylactic migraine treatments and
therefore have a high unmet medical need.
Study design
This study uses a single-cohort, 2-treatment arm (erenumab versus oral SoC
prophylactic treatment), parallel-group randomized (2:1 [erenumab (70mg
or140mg): SoC oral prophylactic]), open-label design in adult patients with
episodic migraine who have previously failed 1 or 2 prophylactic migraine
treatments.
The following periods are included in the study design, with study visits at
4-week intervals after completion of screening:
Screening Period (0-2 weeks), Baseline Period (4 weeks) - Open-Label Randomized
Treatment Period (52 weeks) * Extension Period (52 weeks)
Intervention
AMG334
Study burden and risks
Possible risks of participation in this study are any side effects of AMG334,
the time investment and extra assesments. See protocol, SmPC and the ABR form
section E.
Mogelijke risico's en belasting van deelname aan dit onderzoek zijn
bijwerkingen van AMG334, de tijdsinvestering en risico's extra
onderzoeksprocedures. Zie ook protocol,SmPC en het ABR formulier sectie E.
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
- Adults *18 of age upon entry into screening.
- Documented history of migraine (with or without aura) *12 months prior to
screening.
- *4 and <15 days per month of migraine symptoms (based on ICHD-3 criteria)
on average across 3 months prior to screening based on retrospective reporting.
- < 15 days per month of headache symptoms (i.e., migraine and non-migraine)
- Subjects in need for switching by documented failure of 1 or 2 prophylactic
therapies in the last 6 months due to either lack of efficacy or poor
tolerability. For subjects with 1 prior treatment failure, the failure should
have occurred in the last 6 months. For subjects with 2 prior treatment
failures, the second treatment failure should have occurred in the last 6
months.
- During baseline period, confirmed migraine frequency of 4 to 14 migraine days
and < 15 days of headache symptoms.
- During baseline period, *80% compliance with the headache diary.
Exclusion criteria
- Older than 50 years of age at migraine onset.
- Lack of efficacy or poor tolerability with > 2 treatments from the following
7 medication categories for prophylactic treatment of migraine: 1: Divalproex
sodium, sodium valproate, 2: Topiramate, 3: Beta blocker , 4: Tricyclic
antidepressants, 5: Serotonin-norepinephrine reuptake inhibitors, 6:
Flunarizine, verapamil, 7: Lisinopril, candesartan
- Used a prohibited medication, device, or procedure within 2 months prior to
the start of or during baseline or during the treatment period.
- Exposure to botulinum toxin in the head and/or neck region within 4 months
prior to the start of the baseline period, during the baseline period, or
treatment period.
- Taken the following for any indication in any month during the 2 months prior
to the start of the baseline period:
- Ergotamines or triptans on * 10 days per month, or
- Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs],
acetaminophen) on * 15 days per month, or
- Opioid- or butalbital-containing analgesics on *4 days per month, or
- Device, or procedure that potientially may interfere with the intensity or
number of migraine days
- Previous exposure to erenumab or exposure to any other prophylactic
CGRP-targeted therapy (prior to and during the study).
Design
Recruitment
Medical products/devices used
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 | EUCTR2018-001228-20-NL |
| CCMO | NL68689.075.19 |