Phase 4
N=65
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04294147 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change From Baseline in Colonic Transit Time (CTT) at Week 2 — 5.752; -5.348 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Galcanezumab (Drug); Erenumab (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Colonic Transit Time (CTT) at Week 2 |
5.752; -5.348 | — |
| SECONDARY Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2 |
4.123; -7.043 | — |
| SECONDARY Change From Baseline in Gastric Emptying Time (GET) at Week 2 |
-1.320; -0.582 | — |
| SECONDARY Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2 |
-0.551; -0.719 | — |
| SECONDARY Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2 |
5.150; -5.957 | — |
| SECONDARY Change From Baseline in Motility Index by Quartile in the Colon at Week 2 |
1.111; 0.367; 0.218; -0.251; 0.926; -0.298 | — |
| SECONDARY Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 |
-0.041; 0.022; -0.090; 0.071; -0.042; 0.074 | — |
| SECONDARY Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 |
-0.44; -0.040; -0.48; 0.023 | — |
| SECONDARY Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 |
-1.28; 0.31; -1.13; 0.54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04294147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.