A Phase 2 Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Status: | Active, not recruiting |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 11/17/2018 |
Start Date: | August 6, 2013 |
End Date: | November 11, 2019 |
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
A phase 2 study to evaluate the effect of erenumab compared to placebo on the change from
baseline in monthly migraine days in participants with episodic migraine.
baseline in monthly migraine days in participants with episodic migraine.
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase,
a 12-week double-blind treatment phase, an open-label treatment phase for up to 256 weeks,
and an 8-week safety follow-up (12 weeks after the last dose of investigational product).
After implementation of Protocol Amendment 3, participants will increase open-label erenumab
to 140 mg monthly and will have a 12-week safety follow-up (16 weeks after the last dose of
investigational product).
This study is currently ongoing, with 225 participants continuing in the open-label extension
phase. An analysis of the double-blind phase of the study was performed with a data cutoff
date of 25 September 2014.
a 12-week double-blind treatment phase, an open-label treatment phase for up to 256 weeks,
and an 8-week safety follow-up (12 weeks after the last dose of investigational product).
After implementation of Protocol Amendment 3, participants will increase open-label erenumab
to 140 mg monthly and will have a 12-week safety follow-up (16 weeks after the last dose of
investigational product).
This study is currently ongoing, with 225 participants continuing in the open-label extension
phase. An analysis of the double-blind phase of the study was performed with a data cutoff
date of 25 September 2014.
Inclusion Criteria:
- History of migraine for more than12 months prior to screening
- Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior
to screening and during baseline phase
- Headache frequency: < 15 headache days per month (with > 50% of the headache days
being migraine days) in each of the 3 months prior to screening and during baseline
phase
- Demonstrated at least 80% compliance with the eDiary during baseline phase
Exclusion Criteria:
- Older than 50 years of age at migraine onset
- History of cluster headache or basilar or hemiplegic migraine headache
- Unable to differentiate migraine from other headaches
- No therapeutic response with > 2 of the following eight medication categories for
prophylactic treatment of migraine after an adequate therapeutic trial. Medication
categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol,
nadolol, nebivolol, pindolol, propranolol, timolol)
- Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline,
protriptyline)
- Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
- Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100
mg/day)
- Overuse of acute migraine medications in any month during the 3 months prior to
screening or during screening
We found this trial at
42
sites
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