A Phase 4 Single-Blind Study of Gastrointestinal Transit Time in Adult Patients With Migraine Before and After Initiation of a mAb CGRP Antagonist
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- Change From Baseline in Colonic Transit Time (CTT) at Week 2
Study Overview
Brief Summary
The purpose of this study is to measure the gastrointestinal emptying time using the wireless motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with migraine who are taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP) antagonist called galcanezumab or erenumab.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
- •Have a frequency of less than 15 monthly headache days of which up to 14 can be migraine headache days.
- •Participants can be on no more than 1 other migraine preventive treatment (except for tricyclic antidepressants and verapamil which are not allowed) as long as: that participant has had a stable dose of the oral migraine preventive treatment for a minimum of 2 months or participants have received onabotulinumtoxinA for a minimum of 2 cycles prior to screening
Exclusion Criteria
- •Participants with a history of gastric bezoars, swallowing disorders, severe dysphagia to food or pills, suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
- •History of any abdominal surgery within the past 3 months or GI surgery with the exception of cholecystectomy, appendectomy, or Nissen fundoplication
- •History of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, or diverticulitis
- •Participants with type 1 or type 2 diabetes
- •Participants with cardiac pacemakers or other implanted or portable electromechanical device
- •Participants with a body mass index of ≥40 kilograms per square meter (kg/m²)
- •Women who are pregnant or nursing
- •Participants currently on mAb CGRP antagonists or have received a mAb CGRP antagonist within the past 6 months prior to visit 1
- •Participants who have received an oral CGRP antagonist (gepant) in the last 14 days prior to Visit 1
Arms & Interventions
Galcanezumab
Participants received a single subcutaneous (SC) dose of 240 milligram (mg) Galcanezumab.
Intervention: Galcanezumab (Drug)
Erenumab
Participants received a single SC dose of 140 mg Erenumab.
Intervention: Erenumab (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Colonic Transit Time (CTT) at Week 2
Time Frame: Baseline, Week 2
Least squares (LS) mean change from baseline was calculated using analysis of covariance (ANCOVA) model with categorical effects of treatment, pooled investigative site, Body mass index (BMI) category (\<30kg/m2, ≥30 kg/m2) and baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days) as well as the continuous baseline CTT (hours). A negative change from baseline indicates a decrease in CTT and a positive change from baseline indicate an increase in CTT.
Secondary Outcomes
- Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2(Baseline, Week 2)
- Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4(Baseline, Week 2, Week 4)
- Change From Baseline in Gastric Emptying Time (GET) at Week 2(Baseline, Week 2)
- Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2(Baseline, Week 2)
- Change From Baseline in Motility Index by Quartile in the Colon at Week 2(Baseline, Week 2)
- Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4(Baseline, Week 2, Week 4)
- Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2(Baseline, Week 2)
- Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4(Baseline, Week 2, Week 4)