Study of Intravenous Erenumab in Patients With Status Migrainosus

NCT04920331 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 19-006424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label, pilot study.

Conditions

Status Migrainosus

Outcome Measures

Primary Outcomes (1)

• Pain relief at 2 hours

  Number of subjects with decreased pain from moderate or severe at baseline to mild or none at 2 hours after treatment

  2 hours after treatment

Secondary Outcomes (11)

• Pain freedom at 2 hours

  2 hours after treatment

• Absence of most bothersome symptom at 2 hours

  2 hours after treatment

• Relief of most bothersome symptom at 2 hours

  2 hours after treatment

• Pain freedom at 24 hours

  24 hours after treatment

• Pain relief at 24 hours

  24 hours after treatment

Study Arms (1)

Erenumab

EXPERIMENTAL

Subjects with episodes of status migrainosus will receive a single dose of IV erenumab

Biological: Erenumab

Interventions

Erenumab BIOLOGICAL

140mg single intravenous administration (60 minutes)

Erenumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 70 years.
• History of migraines (with or without aura) for ≥ 12 months and history of at least 1 episode of status migrainosus based on medical records and/or patient self-report in their lifetime.
• Currently experiencing an episode of status migrainosus (non-menstrually related) per ICHD3 criteria of ≥ 3 and \< 6 days.
• Migraine frequency: ≥ 2 and \< 10 migraine days per month on average across the 3 months prior to screening.
• Headache (i.e., migraine and non-migraine headache) frequency: \< 15 headache days per month on average across the 3 months prior to screening.
• Agree to withhold acute treatments for 24 hours after receiving erenumab IV unless medically necessary.

You may not qualify if:

• Older than 50 years of age at migraine onset.
• History of cluster headache or hemiplegic migraine headache.
• Past (within 4 months) or present exposure to a CGRP monoclonal antibody or CGRP small molecule receptor antagonist for migraine treatment.
• Present exposure to lasmiditan.
• New acute treatment within 7 days.
• New preventive treatment within 4 weeks.
• \> 15 days acute treatment use, opioid or barbiturate use \> 4 days per month.
• Use of acute treatment within 6 hours of the infusion.
• Unable to differentiate migraine from other headaches.
• Procedures (e.g., nerve blocks) or neuromodulatory devices within 7 days.
• History of major psychiatric disorder.
• History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
• History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
• Females who are pregnant, breastfeeding, or who are trying to become pregnant.
• Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who:

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Juliana VanderPluym, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: September 7, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

US (1)