A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
A Phase 4 Single-Blind Study of Gastrointestinal Transit Time in Adult Patients With Migraine Before and After Initiation of a mAb CGRP Antagonist
2 other identifiers
interventional
65
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2020
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedResults Posted
Study results publicly available
March 22, 2022
CompletedMarch 22, 2022
February 1, 2022
5 months
March 2, 2020
February 23, 2022
February 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Colonic Transit Time (CTT) at 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.
Baseline, Week 2
Secondary Outcomes (8)
Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2
Baseline, Week 2
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 Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2
Baseline, Week 2
Change From Baseline in Motility Index by Quartile in the Colon at Week 2
Baseline, Week 2
- +3 more secondary outcomes
Study Arms (2)
Galcanezumab
EXPERIMENTALParticipants received a single subcutaneous (SC) dose of 240 milligram (mg) Galcanezumab.
Erenumab
ACTIVE COMPARATORParticipants received a single SC dose of 140 mg Erenumab.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Clinical Research Institute LLC
Los Angeles, California, 90048, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
CMR of Greater New Haven
Waterbury, Connecticut, 06708, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 3, 2020
Study Start
October 6, 2020
Primary Completion
March 5, 2021
Study Completion
March 5, 2021
Last Updated
March 22, 2022
Results First Posted
March 22, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.