Clinical trial NCT04294147: A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Official title: A Phase 4 Single-Blind Study of Gastrointestinal Transit Time in Adult Patients With Migraine Before and After Initiation of a mAb CGRP Antagonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: prevention
prophylaxis
headache
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Colonic Transit Time (CTT) at Week 2
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Gastric Emptying Time (GET) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Motility Index by Quartile in the Colon at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4
timeFrame: Baseline, Week 2, Week 4
measure: Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4
timeFrame: Baseline, Week 2, Week 4
measure: Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4
timeFrame: Baseline, Week 2, Week 4
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Research Institute LLC
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Waterbury
country: United States
facility: CMR of Greater New Haven
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: