Trial Search Results

Study of Sustained Benefit of Erenumab in Adult Episodic Migraine Patients

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Amgen

Collaborator: Novartis

Stanford Investigator(s):

Intervention(s):

  • Drug: Erenumab
  • Drug: Oral Prophylactic

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   - Written informed consent must be obtained before any assessment is performed.

   - Adults greater than or equal to 18 years of age upon entry into screening.

   - Documented history of migraine (with or without aura) greater than or equal to 12
   months prior to screening according to the International Classification of Headache
   Disorders-3rd Edition (ICHD-3).

   - Greater than or equal to 4 and less than 15 days per month of migraine symptoms (based
   on ICHD-3 criteria) on average across 3 months prior to screening based on
   retrospective reporting.

   - Less than 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 treatments
   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: Confirmed migraine frequency of 4 to 14 migraine days and less than
   15 days of headache symptoms.

   - During baseline: greater than or equal to 80% compliance with the headache diary.

Exclusion Criteria:

   - Subjects meeting any of the following criteria are not eligible for inclusion in this
   study.

      - Older than 50 years of age at migraine onset.

      - History of cluster headache or hemiplegic migraine headache.

      - Unable to differentiate migraine from other headaches.

      - Lack of efficacy or poor tolerability with greater than 2 treatments from the 7
      medication categories for prophylactic treatment of migraine after an adequate
      therapeutic trial.

   - Efficacy failure is defined as no meaningful reduction in headache frequency,
   duration, and/or severity after administration of the medication for at least 6 weeks
   at the generally accepted therapeutic dose(s) based on the investigator's assessment.

   - Tolerability failure is defined as documented discontinuation due to adverse events of
   the respective medication during the last 6 months prior to screening.

   - The following scenarios do not constitute lack of therapeutic response:

   - Lack of sustained response to a medication.

   - Patient decision to halt treatment due to improvement.

   - Used a prohibited medication from the 7 categories of prior prophylactic medications
   within 3 months prior to the start of and during baseline for a non-migraine
   indication if dose is not stable

   - Exposure to botulinum toxin in the head and/or neck region within 4 months.

   - 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 greater than or equal to 10 days per month, or Simple
      analgesics (non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on
      greater than or equal to 15 days per month, or

      - Opioid- or butalbital-containing analgesics on greater than or equal to 4 days
      per month.

   - Device, or procedure that potentially may interfere with the intensity or number of
   migraine days within 2 months.

   - History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or
   current evidence of depression. Subjects with anxiety disorder and/or major depressive
   disorders are permitted in the study if they are considered by the investigator to be
   stable and are taking no more than 1 medication for each disorder. Subjects must have
   been on a stable dose within the 3 months prior to the start of the baseline period.

   - History of seizure disorder or other significant neurological conditions other than
   migraine. Note: a single childhood febrile seizure is not exclusionary.

   - History of malignancy of any organ system (other than localized basal cell carcinoma
   of the skin or in situ cervical cancer), treated or untreated, within the past 5
   years, regardless of whether there is evidence of local recurrence or metastases.

   - Human immunodeficiency virus (HIV) infection by history.

   - History or evidence of any other unstable or clinically significant medical condition
   or clinically significant vital sign, laboratory, or electrocardiogram (ECG)
   abnormality during that could pose a risk to subject safety or interfere with the
   study evaluation.

   - Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary
   artery bypass surgery or other re-vascularization procedures within 6 months prior to
   screening.

   - Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if
   this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal
   Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also
   included in the Suicidal Behavior section), if this behavior occurred in the past 2
   years.

   - Evidence of drug or alcohol abuse or dependence, based on Investigator discretion
   within 12 months.

   - Pregnant or nursing (lactating) women.

   - Women of child-bearing potential must use contraception during dosing with study
   treatment.

   - Use of other investigational drugs within 5 half-lives of enrollment, or until the
   expected pharmacodynamic effect has returned to baseline, whichever is longer.

   - History of hypersensitivity to any of the study drugs or its excipients or to drugs of
   similar chemical classes.

   - Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted
   therapy (prior to the study).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting