Trial Outcomes & Findings for A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist (NCT NCT04294147)
NCT ID: NCT04294147
Last Updated: 2022-03-22
Results Overview
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.
COMPLETED
PHASE4
65 participants
Baseline, Week 2
2022-03-22
Participant Flow
Participant milestones
| Measure |
140 mg Erenumab SC
Participants received a single subcutaneous (SC) dose of 140 milligram (mg) Erenumab.
|
240 mg Galcanezumab SC
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
Received at Least One Dose of Study Drug
|
32
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
140 mg Erenumab SC
Participants received a single subcutaneous (SC) dose of 140 milligram (mg) Erenumab.
|
240 mg Galcanezumab SC
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
140 mg Erenumab SC
n=32 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=33 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 11.4 • n=32 Participants
|
38 years
STANDARD_DEVIATION 9.5 • n=33 Participants
|
39.3 years
STANDARD_DEVIATION 10.5 • n=65 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=32 Participants
|
28 Participants
n=33 Participants
|
55 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=32 Participants
|
15 Participants
n=33 Participants
|
27 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=32 Participants
|
18 Participants
n=33 Participants
|
37 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=32 Participants
|
26 Participants
n=33 Participants
|
49 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=32 Participants
|
33 Participants
n=33 Participants
|
65 Participants
n=65 Participants
|
|
Colonic transit time
|
31.5 hours
STANDARD_DEVIATION 28.1 • n=32 Participants
|
28.3 hours
STANDARD_DEVIATION 24.1 • n=33 Participants
|
29.9 hours
STANDARD_DEVIATION 26.0 • n=65 Participants
|
|
Whole Gut Transit Time
|
41.9 hours
STANDARD_DEVIATION 30.3 • n=32 Participants
|
42.3 hours
STANDARD_DEVIATION 29.8 • n=33 Participants
|
42.1 hours
STANDARD_DEVIATION 29.8 • n=65 Participants
|
|
Gastric Emptying Time
|
5.3 hours
STANDARD_DEVIATION 6.3 • n=32 Participants
|
9.3 hours
STANDARD_DEVIATION 17.4 • n=33 Participants
|
7.3 hours
STANDARD_DEVIATION 13.2 • n=65 Participants
|
|
Small Intestine Bowel Transit Time
|
5.1 hours
STANDARD_DEVIATION 1.6 • n=32 Participants
|
4.7 hours
STANDARD_DEVIATION 2.2 • n=33 Participants
|
4.9 hours
STANDARD_DEVIATION 1.9 • n=65 Participants
|
|
Combined Small and Large Intestine Bowel Transit Time
|
36.6 hours
STANDARD_DEVIATION 28.6 • n=32 Participants
|
33.0 hours
STANDARD_DEVIATION 24.7 • n=33 Participants
|
34.8 hours
STANDARD_DEVIATION 26.6 • n=65 Participants
|
|
Motility Index (MI) by Quartile in the Colon
Quartile 1 of Colon
|
12.352 motility index
STANDARD_DEVIATION 2.8544 • n=28 Participants • 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.
|
12.201 motility index
STANDARD_DEVIATION 2.7862 • n=31 Participants • 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.
|
12.2765 motility index
STANDARD_DEVIATION 2.8203 • n=59 Participants • 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.
|
|
Motility Index (MI) by Quartile in the Colon
Quartile 2 of Colon
|
12.869 motility index
STANDARD_DEVIATION 3.0315 • n=28 Participants • 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.
|
12.444 motility index
STANDARD_DEVIATION 3.0525 • n=31 Participants • 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.
|
12.6565 motility index
STANDARD_DEVIATION 3.042 • n=59 Participants • 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.
|
|
Motility Index (MI) by Quartile in the Colon
Quartile 3 of Colon
|
12.408 motility index
STANDARD_DEVIATION 4.0960 • n=28 Participants • 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.
|
12.318 motility index
STANDARD_DEVIATION 3.9021 • n=31 Participants • 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.
|
12.363 motility index
STANDARD_DEVIATION 3.99905 • n=59 Participants • 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.
|
|
Motility Index (MI) by Quartile in the Colon
Quartile 4 of Colon
|
14.381 motility index
STANDARD_DEVIATION 2.1097 • n=28 Participants • 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.
|
13.245 motility index
STANDARD_DEVIATION 2.2947 • n=31 Participants • 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.
|
13.813 motility index
STANDARD_DEVIATION 2.2022 • n=59 Participants • 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.
|
|
Gastrointestinal Symptom Rating Scale
Abdominal pain syndrome
|
1.2 score on a scale
STANDARD_DEVIATION 0.5 • n=32 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 0.3 • n=33 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 0.4 • n=65 Participants
|
|
Gastrointestinal Symptom Rating Scale
Reflux syndrome
|
1.1 score on a scale
STANDARD_DEVIATION 0.3 • n=32 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 0.3 • n=33 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 0.3 • n=65 Participants
|
|
Gastrointestinal Symptom Rating Scale
Indigestion syndrome
|
1.2 score on a scale
STANDARD_DEVIATION 0.3 • n=32 Participants
|
1.3 score on a scale
STANDARD_DEVIATION 0.5 • n=33 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 0.4 • n=65 Participants
|
|
Gastrointestinal Symptom Rating Scale
Constipation syndrome
|
1.1 score on a scale
STANDARD_DEVIATION 0.1 • n=32 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 0.2 • n=33 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 0.2 • n=65 Participants
|
|
Gastrointestinal Symptom Rating Scale
Diarrhea syndrome
|
1.1 score on a scale
STANDARD_DEVIATION 0.3 • n=32 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 0.4 • n=33 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 0.4 • n=65 Participants
|
|
Bristol Stool Form Scale
|
3.6 score on a scale
STANDARD_DEVIATION 0.9 • n=32 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 1.1 • n=33 Participants
|
3.7 score on a scale
STANDARD_DEVIATION 1.0 • n=65 Participants
|
|
Weekly spontaneous bowel movements (SBMs)
|
8.6 SBMs per week
STANDARD_DEVIATION 3.7 • n=32 Participants
|
9.2 SBMs per week
STANDARD_DEVIATION 5.7 • n=33 Participants
|
8.9 SBMs per week
STANDARD_DEVIATION 4.8 • n=65 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline CTT assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Change From Baseline in Colonic Transit Time (CTT) at Week 2
|
5.752 hours
Standard Error 5.7234
|
-5.348 hours
Standard Error 5.4177
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline WGTT assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Change From Baseline in Whole Gut Transit Time (WGTT) at Week 2
|
4.123 hours
Standard Error 5.9808
|
-7.043 hours
Standard Error 5.6307
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline GET assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Change From Baseline in Gastric Emptying Time (GET) at Week 2
|
-1.320 hours
Standard Error 1.0299
|
-0.582 hours
Standard Error 0.9691
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline SBTT assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Change From Baseline in Small Intestine Bowel Transit Time (SBTT) at Week 2
|
-0.551 hours
Standard Error 0.3138
|
-0.719 hours
Standard Error 0.2935
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline SLBTT assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Change From Baseline in Combined Small and Large Intestine Bowel Transit Time (SLBTT) at Week 2
|
5.150 hours
Standard Error 5.6590
|
-5.957 hours
Standard Error 5.3549
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: 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.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=28 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=31 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
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
|
0.367 motility index
Standard Error 0.4912
|
|
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
|
-0.251 motility index
Standard Error 0.6813
|
|
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
|
-0.298 motility index
Standard Error 0.7016
|
|
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
|
-0.035 motility index
Standard Error 0.4445
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline GSRS assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=32 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=33 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
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
|
0.022 score on a scale
Standard Error 0.0799
|
|
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
|
0.071 score on a scale
Standard Error 0.0713
|
|
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
|
0.074 score on a scale
Standard Error 0.0729
|
|
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
|
0.17 score on a scale
Standard Error 0.082
|
|
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
|
-0.011 score on a scale
Standard Error 0.0814
|
|
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
|
0.20 score on a scale
Standard Error 0.091
|
|
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
|
0.38 score on a scale
Standard Error 0.148
|
|
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
|
0.43 score on a scale
Standard Error 0.153
|
|
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
|
-0.063 score on a scale
Standard Error 0.0352
|
|
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
|
0.072 score on a scale
Standard Error 0.0807
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline BSFS assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=32 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=33 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
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
|
-0.040 score on a scale
Standard Error 0.1554
|
|
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
|
0.023 score on a scale
Standard Error 0.1710
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4Population: All randomized participants who received at least one dose of study drug and had baseline, post-baseline weekly SBM assessments.
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.
Outcome measures
| Measure |
140 mg Erenumab SC
n=32 Participants
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=33 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
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
|
0.31 SBMs per week
Standard Error 0.517
|
|
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
|
0.54 SBMs per week
Standard Error 0.484
|
Adverse Events
140 mg Erenumab SC
240 mg Galcanezumab SC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
140 mg Erenumab SC
n=32 participants at risk
Participants received a single SC dose of 140 mg Erenumab.
|
240 mg Galcanezumab SC
n=33 participants at risk
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/32 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
6.1%
2/33 • Number of events 3 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
15.6%
5/32 • Number of events 5 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 1 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
6.2%
2/32 • Number of events 2 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60