Migraine
Conditions
Keywords
prevention, prophylaxis, headache
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.
Interventions
DRUGGalcanezumab
Administered SC
DRUGErenumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Colonic Transit Time (CTT) at Week 2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Gastric Emptying Time (GET) at Week 2 | Baseline, 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. |
| Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2 | Baseline, 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. |
| Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2 | Baseline, 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. |
| Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2 | Baseline, 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. |
| Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Baseline, Week 2, Week 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. |
| Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 | Baseline, Week 2, Week 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. |
| Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 | Baseline, Week 2, Week 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. |
| Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 140 mg Erenumab SC Participants received a single SC dose of 140 mg Erenumab. | 32 |
| 240 mg Galcanezumab SC Participants received a single SC dose of 240 mg Galcanezumab. | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | 240 mg Galcanezumab SC | 140 mg Erenumab SC | Total |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 9.5 | 40.7 years STANDARD_DEVIATION 11.4 | 39.3 years STANDARD_DEVIATION 10.5 |
| Bristol Stool Form Scale | 3.8 score on a scale STANDARD_DEVIATION 1.1 | 3.6 score on a scale STANDARD_DEVIATION 0.9 | 3.7 score on a scale STANDARD_DEVIATION 1 |
| Colonic transit time | 28.3 hours STANDARD_DEVIATION 24.1 | 31.5 hours STANDARD_DEVIATION 28.1 | 29.9 hours STANDARD_DEVIATION 26 |
| Combined Small and Large Intestine Bowel Transit Time | 33.0 hours STANDARD_DEVIATION 24.7 | 36.6 hours STANDARD_DEVIATION 28.6 | 34.8 hours STANDARD_DEVIATION 26.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 12 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 19 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Gastric Emptying Time | 9.3 hours STANDARD_DEVIATION 17.4 | 5.3 hours STANDARD_DEVIATION 6.3 | 7.3 hours STANDARD_DEVIATION 13.2 |
| Gastrointestinal Symptom Rating Scale Abdominal pain syndrome | 1.2 score on a scale STANDARD_DEVIATION 0.3 | 1.2 score on a scale STANDARD_DEVIATION 0.5 | 1.2 score on a scale STANDARD_DEVIATION 0.4 |
| Gastrointestinal Symptom Rating Scale Constipation syndrome | 1.1 score on a scale STANDARD_DEVIATION 0.2 | 1.1 score on a scale STANDARD_DEVIATION 0.1 | 1.1 score on a scale STANDARD_DEVIATION 0.2 |
| Gastrointestinal Symptom Rating Scale Diarrhea syndrome | 1.2 score on a scale STANDARD_DEVIATION 0.4 | 1.1 score on a scale STANDARD_DEVIATION 0.3 | 1.2 score on a scale STANDARD_DEVIATION 0.4 |
| Gastrointestinal Symptom Rating Scale Indigestion syndrome | 1.3 score on a scale STANDARD_DEVIATION 0.5 | 1.2 score on a scale STANDARD_DEVIATION 0.3 | 1.2 score on a scale STANDARD_DEVIATION 0.4 |
| Gastrointestinal Symptom Rating Scale Reflux syndrome | 1.1 score on a scale STANDARD_DEVIATION 0.3 | 1.1 score on a scale STANDARD_DEVIATION 0.3 | 1.1 score on a scale STANDARD_DEVIATION 0.3 |
| Motility Index (MI) by Quartile in the Colon Quartile 1 of Colon | 12.201 motility index STANDARD_DEVIATION 2.7862 | 12.352 motility index STANDARD_DEVIATION 2.8544 | 12.2765 motility index STANDARD_DEVIATION 2.8203 |
| Motility Index (MI) by Quartile in the Colon Quartile 2 of Colon | 12.444 motility index STANDARD_DEVIATION 3.0525 | 12.869 motility index STANDARD_DEVIATION 3.0315 | 12.6565 motility index STANDARD_DEVIATION 3.042 |
| Motility Index (MI) by Quartile in the Colon Quartile 3 of Colon | 12.318 motility index STANDARD_DEVIATION 3.9021 | 12.408 motility index STANDARD_DEVIATION 4.096 | 12.363 motility index STANDARD_DEVIATION 3.99905 |
| Motility Index (MI) by Quartile in the Colon Quartile 4 of Colon | 13.245 motility index STANDARD_DEVIATION 2.2947 | 14.381 motility index STANDARD_DEVIATION 2.1097 | 13.813 motility index STANDARD_DEVIATION 2.2022 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 26 Participants | 23 Participants | 49 Participants |
| Region of Enrollment United States | 33 Participants | 32 Participants | 65 Participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
| Small Intestine Bowel Transit Time | 4.7 hours STANDARD_DEVIATION 2.2 | 5.1 hours STANDARD_DEVIATION 1.6 | 4.9 hours STANDARD_DEVIATION 1.9 |
| Weekly spontaneous bowel movements (SBMs) | 9.2 SBMs per week STANDARD_DEVIATION 5.7 | 8.6 SBMs per week STANDARD_DEVIATION 3.7 | 8.9 SBMs per week STANDARD_DEVIATION 4.8 |
| Whole Gut Transit Time | 42.3 hours STANDARD_DEVIATION 29.8 | 41.9 hours STANDARD_DEVIATION 30.3 | 42.1 hours STANDARD_DEVIATION 29.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 7 / 32 | 3 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
Primary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline CTT assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Colonic Transit Time (CTT) at Week 2 | 5.752 hours | Standard Error 5.7234 |
| 240 mg Galcanezumab SC | Change From Baseline in Colonic Transit Time (CTT) at Week 2 | -5.348 hours | Standard Error 5.4177 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline BSFS assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 | Week 2 | -0.44 score on a scale | Standard Error 0.163 |
| 140 mg Erenumab SC | Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 | Week 4 | -0.48 score on a scale | Standard Error 0.182 |
| 240 mg Galcanezumab SC | Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 | Week 2 | -0.040 score on a scale | Standard Error 0.1554 |
| 240 mg Galcanezumab SC | Change From Baseline in Bristol Stool Form Scale (BSFS) at Weeks 2 and 4 | Week 4 | 0.023 score on a scale | Standard Error 0.171 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline SLBTT assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2 | 5.150 hours | Standard Error 5.659 |
| 240 mg Galcanezumab SC | Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2 | -5.957 hours | Standard Error 5.3549 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline GET assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Gastric Emptying Time (GET) at Week 2 | -1.320 hours | Standard Error 1.0299 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastric Emptying Time (GET) at Week 2 | -0.582 hours | Standard Error 0.9691 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline GSRS assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Abdominal pain syndrome - Week 2 | -0.041 score on a scale | Standard Error 0.0826 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Abdominal pain syndrome - Week 4 | -0.090 score on a scale | Standard Error 0.0748 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Reflux syndrome - Week 2 | -0.042 score on a scale | Standard Error 0.0756 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Reflux syndrome - Week 4 | 0.078 score on a scale | Standard Error 0.0862 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Indigestion syndrome - Week 2 | 0.026 score on a scale | Standard Error 0.0844 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Indigestion syndrome - Week 4 | 0.005 score on a scale | Standard Error 0.0955 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | constipation syndrome - Week 2 | 0.41 score on a scale | Standard Error 0.153 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | constipation syndrome - Week 4 | 0.25 score on a scale | Standard Error 0.161 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Diarrhea syndrome - Week 2 | -0.076 score on a scale | Standard Error 0.0367 |
| 140 mg Erenumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Diarrhea syndrome - Week 4 | -0.057 score on a scale | Standard Error 0.0852 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | constipation syndrome - Week 4 | 0.43 score on a scale | Standard Error 0.153 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Abdominal pain syndrome - Week 2 | 0.022 score on a scale | Standard Error 0.0799 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Indigestion syndrome - Week 4 | 0.20 score on a scale | Standard Error 0.091 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Abdominal pain syndrome - Week 4 | 0.071 score on a scale | Standard Error 0.0713 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Diarrhea syndrome - Week 4 | 0.072 score on a scale | Standard Error 0.0807 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Reflux syndrome - Week 2 | 0.074 score on a scale | Standard Error 0.0729 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | constipation syndrome - Week 2 | 0.38 score on a scale | Standard Error 0.148 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Reflux syndrome - Week 4 | 0.17 score on a scale | Standard Error 0.082 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Diarrhea syndrome - Week 2 | -0.063 score on a scale | Standard Error 0.0352 |
| 240 mg Galcanezumab SC | Change From Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) at Weeks 2 and 4 | Indigestion syndrome - Week 2 | -0.011 score on a scale | Standard Error 0.0814 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline MI assessments for each quartile in the colon.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 1 of Colon | 1.111 motility index | Standard Error 0.5226 |
| 140 mg Erenumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 2 of Colon | 0.218 motility index | Standard Error 0.7258 |
| 140 mg Erenumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 3 of Colon | 0.926 motility index | Standard Error 0.7477 |
| 140 mg Erenumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 4 of Colon | 0.489 motility index | Standard Error 0.4723 |
| 240 mg Galcanezumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 4 of Colon | -0.035 motility index | Standard Error 0.4445 |
| 240 mg Galcanezumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 1 of Colon | 0.367 motility index | Standard Error 0.4912 |
| 240 mg Galcanezumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 3 of Colon | -0.298 motility index | Standard Error 0.7016 |
| 240 mg Galcanezumab SC | Change From Baseline in Motility Index by Quartile in the Colon at Week 2 | Quartile 2 of Colon | -0.251 motility index | Standard Error 0.6813 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline SBTT assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2 | -0.551 hours | Standard Error 0.3138 |
| 240 mg Galcanezumab SC | Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2 | -0.719 hours | Standard Error 0.2935 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline weekly SBM assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 | Week 2 | -1.28 SBMs per week | Standard Error 0.537 |
| 140 mg Erenumab SC | Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 | Week 4 | -1.13 SBMs per week | Standard Error 0.511 |
| 240 mg Galcanezumab SC | Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 | Week 2 | 0.31 SBMs per week | Standard Error 0.517 |
| 240 mg Galcanezumab SC | Change From Baseline in the Weekly Spontaneous Bowel Movements (SBMs) at Weeks 2 and 4 | Week 4 | 0.54 SBMs per week | Standard Error 0.484 |
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline WGTT assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 140 mg Erenumab SC | Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2 | 4.123 hours | Standard Error 5.9808 |
| 240 mg Galcanezumab SC | Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2 | -7.043 hours | Standard Error 5.6307 |