A Phase 4 interventional study of Galcanezumab and Erenumab in Migraine, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Participants received a single subcutaneous (SC) dose of 240 milligram (mg) Galcanezumab.
Drug: Galcanezumab
Participants received a single SC dose of 140 mg Erenumab.
Drug: Erenumab
Administered SC
Also known as: LY2951742
Administered SC
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.
Time frame: Baseline, Week 2
Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2
Least squares (LS) mean change from baseline was calculated using 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 WGTT (hours). A negative change from baseline indicates a decrease in WGTT and a positive change from baseline indicate an increase in WGTT.
Time frame: Baseline, Week 2
Change From Baseline in Gastric Emptying Time (GET) at Week 2
Least squares (LS) mean change from baseline was calculated using 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 GET (hours). A negative change from baseline indicates a decrease in GET and a positive change from baseline indicate an increase in GET.
Time frame: Baseline, Week 2
Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2
Least squares (LS) mean change from baseline was calculated using 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 SBTT (hours). A negative change from baseline indicates a decrease in SBTT and a positive change from baseline indicate an increase in SBTT.
Time frame: Baseline, Week 2
Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2
Least squares (LS) mean change from baseline was calculated using 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 SLBTT (hours). A negative change from baseline indicates a decrease in SLBTT and a positive change from baseline indicate an increase in SLBTT.
Time frame: Baseline, Week 2
Change From Baseline in Motility Index by Quartile in the Colon at Week 2
Motility index (MI) is a calculated outcome, based on the formula: In (Number of contractions x Σpressure amplitudes +1) where ln = natural logorithm, Σ = Sum. Least squares (LS) mean change from baseline was calculated using 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 MI. A negative change from baseline indicates a decrease in colonic contractions or pressure or both, and a positive change from baseline indicates an increase in colonic contractions or pressure or both.
Time frame: Baseline, Week 2
Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4
GSRS is a validated 15-item questionnaire that evaluates the common symptoms of GI disorders. It has five subscales: abdominal pain (abdominal pain, hunger pains, nausea), reflux (heartburn, acid reflux), indigestion (rumbling, bloating, belching, and increased flatus/breaking wind), constipation (constipation, hard stools, and sensation of not completely emptying the bowels), and diarrhea (diarrhea, loose stools, urgent need to have a bowel movement) syndromes. Subscale scores range from 1 to 7. Higher scores indicate greater severity of symptoms. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction.
Time frame: Baseline, Week 2, Week 4
Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4
The BSFS is a 7-point ordinal scale which classifies the type of bowel movement based on the appearance of stool. Score 1, 2 indicate constipation (harder stools); 6, 7 indicate diarrhea (loose/liquid stools ); 3 to 5 are considered normal. A better score would trend toward the middle of the scale (3 to 5), while scores at either end of the scale correspond to worse outcomes. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction.
Time frame: Baseline, Week 2, Week 4
Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4
Weekly SBM is the number of spontaneous (un-aided by laxatives, enemas, or suppositories) bowel movements that a participant has had in the past 7 days. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction. A negative change from baseline indicates a decrease in weekly SBMs, and a positive change from baseline indicates an increase in weekly SBMs.
Time frame: Baseline, Week 2, Week 4
| Milestone | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Started | 32 | 33 |
| Received at least one dose of study drug | 32 | 33 |
| Completed | 30 | 33 |
| Not completed | 2 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
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.
| hours | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Change From Baseline in Colonic Transit Time (CTT) at Week 2 | 5.752 ± 5.7234 | -5.348 ± 5.4177 |
Least squares (LS) mean change from baseline was calculated using 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 WGTT (hours). A negative change from baseline indicates a decrease in WGTT and a positive change from baseline indicate an increase in WGTT.
| hours | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2 | 4.123 ± 5.9808 | -7.043 ± 5.6307 |
Least squares (LS) mean change from baseline was calculated using 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 GET (hours). A negative change from baseline indicates a decrease in GET and a positive change from baseline indicate an increase in GET.
| hours | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Change From Baseline in Gastric Emptying Time (GET) at Week 2 | -1.320 ± 1.0299 | -0.582 ± 0.9691 |
Least squares (LS) mean change from baseline was calculated using 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 SBTT (hours). A negative change from baseline indicates a decrease in SBTT and a positive change from baseline indicate an increase in SBTT.
| hours | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2 | -0.551 ± 0.3138 | -0.719 ± 0.2935 |
Least squares (LS) mean change from baseline was calculated using 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 SLBTT (hours). A negative change from baseline indicates a decrease in SLBTT and a positive change from baseline indicate an increase in SLBTT.
| hours | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2 | 5.150 ± 5.6590 | -5.957 ± 5.3549 |
Motility index (MI) is a calculated outcome, based on the formula: In (Number of contractions x Σpressure amplitudes +1) where ln = natural logorithm, Σ = Sum. Least squares (LS) mean change from baseline was calculated using 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 MI. A negative change from baseline indicates a decrease in colonic contractions or pressure or both, and a positive change from baseline indicates an increase in colonic contractions or pressure or both.
| motility index | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Quartile 1 of Colon | 1.111 ± 0.5226 | 0.367 ± 0.4912 |
| Quartile 2 of Colon | 0.218 ± 0.7258 | -0.251 ± 0.6813 |
| Quartile 3 of Colon | 0.926 ± 0.7477 | -0.298 ± 0.7016 |
| Quartile 4 of Colon | 0.489 ± 0.4723 | -0.035 ± 0.4445 |
GSRS is a validated 15-item questionnaire that evaluates the common symptoms of GI disorders. It has five subscales: abdominal pain (abdominal pain, hunger pains, nausea), reflux (heartburn, acid reflux), indigestion (rumbling, bloating, belching, and increased flatus/breaking wind), constipation (constipation, hard stools, and sensation of not completely emptying the bowels), and diarrhea (diarrhea, loose stools, urgent need to have a bowel movement) syndromes. Subscale scores range from 1 to 7. Higher scores indicate greater severity of symptoms. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction.
| score on a scale | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Abdominal pain syndrome - Week 2 | -0.041 ± 0.0826 | 0.022 ± 0.0799 |
| Abdominal pain syndrome - Week 4 | -0.090 ± 0.0748 | 0.071 ± 0.0713 |
| Reflux syndrome - Week 2 | -0.042 ± 0.0756 | 0.074 ± 0.0729 |
| Reflux syndrome - Week 4 | 0.078 ± 0.0862 | 0.17 ± 0.082 |
| Indigestion syndrome - Week 2 | 0.026 ± 0.0844 | -0.011 ± 0.0814 |
| Indigestion syndrome - Week 4 | 0.005 ± 0.0955 | 0.20 ± 0.091 |
| constipation syndrome - Week 2 | 0.41 ± 0.153 | 0.38 ± 0.148 |
| constipation syndrome - Week 4 | 0.25 ± 0.161 | 0.43 ± 0.153 |
| Diarrhea syndrome - Week 2 | -0.076 ± 0.0367 | -0.063 ± 0.0352 |
| Diarrhea syndrome - Week 4 | -0.057 ± 0.0852 | 0.072 ± 0.0807 |
The BSFS is a 7-point ordinal scale which classifies the type of bowel movement based on the appearance of stool. Score 1, 2 indicate constipation (harder stools); 6, 7 indicate diarrhea (loose/liquid stools ); 3 to 5 are considered normal. A better score would trend toward the middle of the scale (3 to 5), while scores at either end of the scale correspond to worse outcomes. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction.
| score on a scale | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Week 2 | -0.44 ± 0.163 | -0.040 ± 0.1554 |
| Week 4 | -0.48 ± 0.182 | 0.023 ± 0.1710 |
Weekly SBM is the number of spontaneous (un-aided by laxatives, enemas, or suppositories) bowel movements that a participant has had in the past 7 days. LS mean change from baseline was calculated using mixed effects model for repeated measures (MMRM) with fixed categorical effects of treatment, pooled investigative site, BMI category (\<30kg/m2, ≥30 kg/m2), baseline migraine frequency (\<8 migraine headache days, ≥8 migraine headache days), week, and treatment-by-week interaction, as well as the continuous fixed covariates of baseline value and baseline-by-week interaction. A negative change from baseline indicates a decrease in weekly SBMs, and a positive change from baseline indicates an increase in weekly SBMs.
| SBMs per week | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| Week 2 | -1.28 ± 0.537 | 0.31 ± 0.517 |
| Week 4 | -1.13 ± 0.511 | 0.54 ± 0.484 |
Collected over Baseline to Follow-up (Up To 28 Days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 140 mg Erenumab SC | 0/32 (0%) | 0/32 (0%) | 7/32 (21.9%) |
| 240 mg Galcanezumab SC | 0/33 (0%) | 0/33 (0%) | 3/33 (9.1%) |
| Event | 140 mg Erenumab SC | 240 mg Galcanezumab SC |
|---|---|---|
| ConstipationGastrointestinal disorders | 5/32 | 1/33 |
| Covid-19Infections and infestations | 2/32 | 0/33 |
| Abdominal pain upperGastrointestinal disorders | 0/32 | 2/33 |
All randomized participants.
| Age, Continuous(years) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Mean | 40.7 ± 11.4 | 38 ± 9.5 | 39.3 ± 10.5 |
| Sex: Female, Male(Participants) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Female | 27 | 28 | 55 |
| Male | 5 | 5 | 10 |
| Ethnicity (NIH/OMB)(Participants) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 15 | 27 |
| Not Hispanic or Latino | 19 | 18 | 37 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 4 | 6 | 10 |
| White | 23 | 26 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| United States | 32 | 33 | 65 |
| Colonic transit time(hours) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Mean | 31.5 ± 28.1 | 28.3 ± 24.1 | 29.9 ± 26.0 |
| Whole Gut Transit Time(hours) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Mean | 41.9 ± 30.3 | 42.3 ± 29.8 | 42.1 ± 29.8 |
| Gastric Emptying Time(hours) | 140 mg Erenumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|
| Mean | 5.3 ± 6.3 | 9.3 ± 17.4 | 7.3 ± 13.2 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Galcanezumab