MEDVADIS RESEARCH

Chronic Low Back Pain Placeholder for Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

TITLE:

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MEDICAL CONTION:

Chronic Low Back Pain

AGE:

34+

SEX/GENDER:

Male

Overview

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Study Details

Inclusion Criteria:

  • At least a 1-year history of migraine with or without aura.
  • Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
  • Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
  • Have regular menstrual cycles of between 21-35 days in length.
  • Less than 15 headache days per month.
  • At least 70% compliance completing screening period and at least 4 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria:

  • History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
  • Clinically significant history of cardiovascular or cerebrovascular disease per the investigator’s opinion.
  • Clinically significant abnormalities in the physical examination as determined by the investigator.
  • Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator’s opinion.
  • Acute headache medication overuse.