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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGBC | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab | Experimental | Participants received a single subcutaneous (SC) dose of 240 milligram (mg) Galcanezumab. |
|
| Erenumab | Active Comparator | Participants received a single SC dose of 140 mg Erenumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute LLC | Los Angeles | California | 90048 | United States | ||
| Pharmacology Research Institute |
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| Label | URL |
|---|---|
| A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a CGRP Antagonist | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 140 mg Erenumab SC | Participants received a single subcutaneous (SC) dose of 140 milligram (mg) Erenumab. |
| FG001 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 140 mg Erenumab SC | Participants received a single SC dose of 140 mg Erenumab. |
| BG001 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline CTT assessments. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Week 2 |
|
Baseline to Follow-up (Up To 28 Days)
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 140 mg Erenumab SC | Participants received a single SC dose of 140 mg Erenumab. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2020 | Jan 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2020 | Jan 27, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
| C000605816 | erenumab |
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| Erenumab | Drug | Administered SC |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 2, Week 4 |
| Newport Beach |
| California |
| 92660 |
| United States |
| CMR of Greater New Haven | Waterbury | Connecticut | 06708 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Colonic transit time | Mean | Standard Deviation | hours |
|
| Whole Gut Transit Time | Mean | Standard Deviation | hours |
|
| Gastric Emptying Time | Mean | Standard Deviation | hours |
|
| Small Intestine Bowel Transit Time | Mean | Standard Deviation | hours |
|
| Combined Small and Large Intestine Bowel Transit Time | Mean | Standard Deviation | hours |
|
| Motility Index (MI) by Quartile in the Colon | 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. | Mean | Standard Deviation | motility index |
|
| Gastrointestinal Symptom Rating Scale | Mean | Standard Deviation | score on a scale |
|
| Bristol Stool Form Scale | Mean | Standard Deviation | score on a scale |
|
| Weekly spontaneous bowel movements (SBMs) | Mean | Standard Deviation | SBMs per week |
|
| OG001 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. |
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline WGTT assessments. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Week 2 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline GET assessments. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Week 2 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline SBTT assessments. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Week 2 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline SLBTT assessments. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Week 2 |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | motility index | Baseline, Week 2 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline GSRS assessments. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 2, Week 4 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline BSFS assessments. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 2, Week 4 |
|
|
|
| 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. | All randomized participants who received at least one dose of study drug and had baseline, post-baseline weekly SBM assessments. | Posted | Least Squares Mean | Standard Error | SBMs per week | Baseline, Week 2, Week 4 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 7 |
| 32 |
| EG001 | 240 mg Galcanezumab SC | Participants received a single SC dose of 240 mg Galcanezumab. | 0 | 33 | 0 | 33 | 3 | 33 |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Quartile 3 of Colon |
|
| Quartile 4 of Colon |
|
| Abdominal pain syndrome - Week 4 |
|
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| Reflux syndrome - Week 2 |
|
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| Reflux syndrome - Week 4 |
|
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| Indigestion syndrome - Week 2 |
|
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| Indigestion syndrome - Week 4 |
|
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| constipation syndrome - Week 2 |
|
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| constipation syndrome - Week 4 |
|
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| Diarrhea syndrome - Week 2 |
|
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| Diarrhea syndrome - Week 4 |
|
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| Week 4 |
|
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| Week 4 |
|
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