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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-CD-LAHP | Other Identifier | Eli Lilly and Company | |
| COL-MIG-105 | Other Identifier | CoLucid Pharmaceuticals | |
| 2011-003229-88 | EudraCT Number |
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| Name | Class |
|---|---|
| CoLucid Pharmaceuticals | INDUSTRY |
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The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 milligrams (mg) Lasmiditan | Experimental | A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods. |
|
| 400 mg Lasmiditan | Experimental | A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods. |
|
| Placebo | Placebo Comparator | Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods. |
|
| Moxifloxacin | Active Comparator | A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | 100 mg administered orally (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex. | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. |
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Inclusion Criteria:
Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
In good physical and mental health as determined by the following:
Exclusion Criteria:
Any of the following cardiac abnormalities on safety screening ECG:
Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
Participants with a family history of Long QT syndrome
History of allergic hypersensitivity to lasmiditan or any component of the formulations
History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
Participants with a history of postural hypotension or fainting
Participant is not able to understand and comply with study requirements, instructions and study restrictions
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Berlin | 14050 | Germany |
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.
All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 ABDC | Day 1 of each treatment period with a washout period of 7-14 days. A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched |
| FG001 | Sequence 2 BCAD | Day 1 of each treatment period with a washout period of 7-14 days. B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) |
| FG002 | Sequence 3 CDBA | Day 1 of each treatment period with a washout period of 7-14 days. C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO |
| FG003 | Sequence 4 DACB | Day 1 of each treatment period with a washout period of 7-14 days. D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
| ||||||||||||||||||||||
| Period 3 |
| ||||||||||||||||||||||
| Period 4 |
|
All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 ABDC | Day 1 of each treatment period with a washout period of 7-14 days. A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched |
| BG001 | Sequence 2 BCAD |
| 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 Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex. | All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data. | Posted | Mean | Standard Deviation | milliseconds | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
75 days
All randomized participants who received at least 1 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 | 100 mg Lasmiditan | 100 mg lasmiditan administered PO in 1 of 4 treatment periods. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pilonidal cyst | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | 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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| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Lasmiditan | Drug | 400 mg administered PO |
|
|
| Placebo | Drug | Placebo administered for lasmiditan or moxifloxacin |
|
| Moxifloxacin | Drug | 400 mg moxifloxacin administered PO |
|
| Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves. | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles. | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | Heart rate was determined during ambulatory blood pressure monitoring (ABPM). | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan. | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan. | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Day 1 of each treatment period with a washout period of 7-14 days.
B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)
| BG002 | Sequence 3 CDBA | Day 1 of each treatment period with a washout period of 7-14 days. C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO |
| BG003 | Sequence 4 DACB | Day 1 of each treatment period with a washout period of 7-14 days. D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO |
| BG004 | 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 |
|
| OG001 | 400 mg Lasmiditan | 400 mg lasmiditan administered PO in 1 of 4 treatment periods |
| OG002 | Placebo | Placebo administered PO in 1 of 4 treatment periods. |
| OG003 | Moxifloxacin | Moxifloxacin administered PO in 1 of 4 treatment periods. |
|
|
|
| Secondary | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | All randomized participants who received at least 1 dose of study drug and have evaluable QTcI data. | Posted | Mean | Standard Deviation | milliseconds | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
|
| Secondary | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves. | All randomized participants who received at least 1 dose of study drug and have evaluable RR interval data. | Posted | Mean | Standard Deviation | milliseconds | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
|
| Secondary | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles. | All randomized participants who received at least 1 dose of study drug and have evaluable QRS data. | Posted | Mean | Standard Deviation | milliseconds | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
|
| Secondary | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | Heart rate was determined during ambulatory blood pressure monitoring (ABPM). | All randomized participants who received at least 1 dose of study drug and have evaluable HR data. | Posted | Mean | Standard Deviation | beats per minute | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
|
| Secondary | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist | All randomized participants who received at least 1 dose of study drug. | Posted | Number | Incidents | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan. | All randomized participants who received at least 1 dose of lasmiditan. | Posted | Mean | Standard Deviation | nanogram per milliliter | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan. | All randomized participants who received at least 1 dose of lasmiditan. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanogram per milliliter | Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 21 |
| 52 |
| EG001 | 400 mg Lasmiditan | 400 mg lasmiditan administered PO in 1 of 4 treatment periods. | 0 | 55 | 0 | 55 | 33 | 55 |
| EG002 | Placebo | Placebo administered PO in 1 of 4 treatment periods. | 0 | 54 | 0 | 54 | 7 | 54 |
| EG003 | Moxifloxacin | Moxifloxacin administered PO in 1 of 4 treatment periods. | 0 | 52 | 1 | 52 | 9 | 52 |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 1 hour postdose |
|
| 1.5 hours postdose |
|
| 2 hours postdose |
|
| 2.5 hours postdose |
|
| 3 hours postdose |
|
| 3.5 hours postdose |
|
| 4 hours postdose |
|
| 6 hours postdose |
|
| 8 hours postdose |
|
| 12 hours postdose |
|
| 24 hours postdose |
|
1 hour postdose
| Mixed Models Analysis |
| LS Mean |
| -5.30 |
| 2-Sided |
| 90 |
| -7.18 |
| -3.42 |
| Non-Inferiority |
The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -5.70 | 2-Sided | 90 | -7.57 | -3.82 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 2 hours postdose | Mixed Models Analysis | LS Mean | -4.47 | 2-Sided | 90 | -6.64 | -2.30 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | -4.53 | 2-Sided | 90 | -6.87 | -2.19 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -2.74 | 2-Sided | 90 | -4.90 | -0.59 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -1.74 | 2-Sided | 90 | -3.86 | 0.39 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -1.66 | 2-Sided | 90 | -3.77 | 0.44 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -1.11 | 2-Sided | 90 | -3.17 | 0.94 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -2.47 | 2-Sided | 90 | -4.58 | -0.35 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -2.15 | 2-Sided | 90 | -3.87 | -0.43 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 0.79 | 2-Sided | 90 | -1.14 | 2.72 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | -4.64 | 2-Sided | 90 | -6.57 | -2.71 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 1 hour postdose | Mixed Models Analysis | LS Mean | -2.49 | 2-Sided | 90 | -4.59 | -0.39 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -0.96 | 2-Sided | 90 | -3.02 | 1.09 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 1.64 | 2-Sided | 90 | -0.46 | 3.73 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 1.61 | 2-Sided | 90 | -0.59 | 3.81 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 2.41 | 2-Sided | 90 | 0.25 | 4.57 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 4.30 | 2-Sided | 90 | 2.48 | 6.12 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 5.15 | 2-Sided | 90 | 3.02 | 7.27 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 6 hours postdose | Mixed Models Analysis | LS Mean | 2.77 | 2-Sided | 90 | 0.75 | 4.79 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 8 hours postdose | Mixed Models Analysis | LS Mean | 1.75 | 2-Sided | 90 | -0.55 | 4.05 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 12 hours postdose | Mixed Models Analysis | LS Mean | 1.75 | 2-Sided | 90 | -0.19 | 3.69 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 24 hours postdose | Mixed Models Analysis | LS Mean | -0.48 | 2-Sided | 90 | -2.44 | 1.48 | Non-Inferiority | The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds. |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | 7.07 | 2-Sided | 90 | 4.72 | 9.41 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | 11.81 | 2-Sided | 90 | 9.94 | 13.69 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 10.95 | 2-Sided | 90 | 9.16 | 12.74 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 11.50 | 2-Sided | 90 | 9.5 | 13.43 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 10.81 | 2-Sided | 90 | 8.9 | 12.71 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 12.35 | 2-Sided | 90 | 10.42 | 14.28 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 12.65 | 2-Sided | 90 | 10.76 | 14.54 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 11.17 | 2-Sided | 90 | 9.23 | 13.10 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | 8.12 | 2-Sided | 90 | 6.02 | 10.22 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | 8.10 | 2-Sided | 90 | 6.01 | 10.19 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | 6.26 | 2-Sided | 90 | 4.23 | 8.28 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 5.74 | 2-Sided | 90 | 3.47 | 8.01 | Superiority |
| 1 hour postdose |
|
| 1.5 hours postdose |
|
| 2 hours postdose |
|
| 2.5 hours postdose |
|
| 3 hours postdose |
|
| 3.5 hours postdose |
|
| 4 hours postdose |
|
| 6 hours postdose |
|
| 8 hours postdose |
|
| 12 hours postdose |
|
| 24 hours postdose |
|
| LS Mean |
| 100.15 |
| 2-Sided |
| 90 |
| 77.81 |
| 122.50 |
| Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 107.11 | 2-Sided | 90 | 83.31 | 130.91 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 74.48 | 2-Sided | 90 | 56.32 | 92.63 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 89.19 | 2-Sided | 90 | 68.77 | 109.61 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 74.98 | 2-Sided | 90 | 55.41 | 94.55 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 52.83 | 2-Sided | 90 | 36.03 | 69.63 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 42.10 | 2-Sided | 90 | 24.86 | 59.35 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | 62.61 | 2-Sided | 90 | 42.39 | 82.83 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | 56.05 | 2-Sided | 90 | 32.49 | 79.61 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | 35.71 | 2-Sided | 90 | 11.79 | 59.63 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | -4.59 | 2-Sided | 90 | -24.66 | 15.47 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | 56.53 | 2-Sided | 90 | 36.72 | 76.35 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | 103.30 | 2-Sided | 90 | 83.88 | 122.72 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 94.21 | 2-Sided | 90 | 75.15 | 113.26 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 83.49 | 2-Sided | 90 | 67.98 | 99.00 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 103.64 | 2-Sided | 90 | 87.28 | 120.00 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 89.26 | 2-Sided | 90 | 71.24 | 107.29 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 65.29 | 2-Sided | 90 | 48.28 | 82.30 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 52.85 | 2-Sided | 90 | 36.10 | 69.60 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | 86.09 | 2-Sided | 90 | 66.36 | 105.82 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | 80.12 | 2-Sided | 90 | 58.32 | 101.91 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | 67.58 | 2-Sided | 90 | 44.64 | 90.51 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 7.77 | 2-Sided | 90 | -10.01 | 25.55 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | -22.02 | 2-Sided | 90 | -38.44 | -5.60 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | -38.87 | 2-Sided | 90 | -57.15 | -20.60 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -22.13 | 2-Sided | 90 | -39.35 | -4.91 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | -17.35 | 2-Sided | 90 | -32.15 | -2.56 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | -1.03 | 2-Sided | 90 | -18.17 | 16.12 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -4.77 | 2-Sided | 90 | -21.81 | 12.27 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -16.56 | 2-Sided | 90 | -33.36 | 0.24 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -15.29 | 2-Sided | 90 | -32.94 | 2.37 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | 6.13 | 2-Sided | 90 | -10.86 | 23.11 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | 2.27 | 2-Sided | 90 | -15.25 | 19.80 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -11.95 | 2-Sided | 90 | -33.46 | 9.56 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | -0.31 | 2-Sided | 90 | -17.32 | 16.69 | Superiority |
| 1 hours postdose |
|
| 1.5 hours postdose |
|
| 2 hours postdose |
|
| 2.5 hours postdose |
|
| 3 hours postdose |
|
| 3.5 hours postdose |
|
| 4 hours postdose |
|
| 6 hours postdose |
|
| 8 hours postdose |
|
| 12 hours postdose |
|
| 24 hours postdose |
|
| LS Mean |
| -0.23 |
| 2-Sided |
| 90 |
| -0.61 |
| 0.15 |
| Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -0.12 | 2-Sided | 90 | -0.47 | 0.23 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | -0.44 | 2-Sided | 90 | -0.81 | -0.07 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | -0.55 | 2-Sided | 90 | -0.95 | -0.15 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -0.38 | 2-Sided | 90 | -0.77 | 0.00 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -0.41 | 2-Sided | 90 | -0.72 | -0.10 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -0.35 | 2-Sided | 90 | -0.66 | -0.04 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -0.54 | 2-Sided | 90 | -0.98 | -0.09 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -0.14 | 2-Sided | 90 | -0.58 | 0.31 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -0.29 | 2-Sided | 90 | -0.70 | 0.12 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 0.43 | 2-Sided | 90 | 0.01 | 0.84 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | -0.19 | 2-Sided | 90 | -0.59 | 0.21 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | 0.48 | 2-Sided | 90 | 0.06 | 0.89 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 0.56 | 2-Sided | 90 | 0.19 | 0.93 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 0.40 | 2-Sided | 90 | 0.02 | 0.77 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 0.51 | 2-Sided | 90 | 0.13 | 0.88 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 0.33 | 2-Sided | 90 | -0.05 | 0.71 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 0.32 | 2-Sided | 90 | -0.02 | 0.67 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 0.50 | 2-Sided | 90 | 0.16 | 0.84 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -0.10 | 2-Sided | 90 | -0.56 | 0.36 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -0.11 | 2-Sided | 90 | -0.56 | 0.33 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -0.39 | 2-Sided | 90 | -0.84 | 0.06 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 0.04 | 2-Sided | 90 | -0.37 | 0.45 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | -0.09 | 2-Sided | 90 | -0.45 | 0.28 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | -0.10 | 2-Sided | 90 | -0.46 | 0.27 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 0.25 | 2-Sided | 90 | -0.10 | 0.60 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 0.01 | 2-Sided | 90 | -0.38 | 0.40 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 0.02 | 2-Sided | 90 | -0.34 | 0.37 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -0.09 | 2-Sided | 90 | -0.44 | 0.25 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -0.39 | 2-Sided | 90 | -0.76 | -0.03 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -0.38 | 2-Sided | 90 | -0.73 | -0.03 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -0.60 | 2-Sided | 90 | -1.03 | -0.17 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -0.39 | 2-Sided | 90 | -0.82 | 0.04 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -0.31 | 2-Sided | 90 | -0.70 | 0.09 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 0.19 | 2-Sided | 90 | -0.23 | 0.61 | Superiority |
| 1 hour postdose |
|
| 1.5 hours postdose |
|
| 2 hours postdose |
|
| 2.5 hours postdose |
|
| 3 hours postdose |
|
| 3.5 hours postdose |
|
| 4 hours postdose |
|
| 6 hours postdose |
|
| 8 hours postdose |
|
| 12 hours postdose |
|
| 24 hours postdose |
|
| LS Mean |
| -5.09 |
| 2-Sided |
| 90 |
| -6.29 |
| -3.88 |
| Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -5.57 | 2-Sided | 90 | -6.81 | -4.32 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | -4.01 | 2-Sided | 90 | -5.00 | -3.01 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | -4.78 | 2-Sided | 90 | -5.91 | -3.65 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -4.14 | 2-Sided | 90 | -5.20 | -3.08 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -2.94 | 2-Sided | 90 | -3.87 | -2.01 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -2.42 | 2-Sided | 90 | -3.42 | -1.42 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -4.61 | 2-Sided | 90 | -6.17 | -3.06 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -3.82 | 2-Sided | 90 | -5.38 | -2.26 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -2.65 | 2-Sided | 90 | -4.33 | -0.97 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | 0.12 | 2-Sided | 90 | -1.22 | 1.46 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | -3.09 | 2-Sided | 90 | -4.16 | -2.02 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | -5.61 | 2-Sided | 90 | -6.65 | -4.58 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | -5.39 | 2-Sided | 90 | -6.42 | -4.35 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | -4.64 | 2-Sided | 90 | -5.55 | -3.72 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | -5.82 | 2-Sided | 90 | -6.77 | -4.87 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | -4.99 | 2-Sided | 90 | -6.03 | -3.96 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | -3.69 | 2-Sided | 90 | -4.68 | -2.71 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | -3.19 | 2-Sided | 90 | -4.21 | -2.17 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -6.29 | 2-Sided | 90 | -7.83 | -4.95 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -5.37 | 2-Sided | 90 | -6.73 | -4.02 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | -4.71 | 2-Sided | 90 | -6.25 | -3.17 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | -0.55 | 2-Sided | 90 | -1.74 | 0.63 | Superiority |
| 30 minutes postdose | Mixed Models Analysis | LS Mean | 1.32 | 2-Sided | 90 | 0.32 | 2.33 | Superiority |
| 1 hour postdose | Mixed Models Analysis | LS Mean | 2.29 | 2-Sided | 90 | 1.19 | 3.40 | Superiority |
| 1.5 hours postdose | Mixed Models Analysis | LS Mean | 1.30 | 2-Sided | 90 | 0.31 | 2.28 | Superiority |
| 2 hours postdose | Mixed Models Analysis | LS Mean | 1.07 | 2-Sided | 90 | 0.17 | 1.97 | Superiority |
| 2.5 hours postdose | Mixed Models Analysis | LS Mean | 0.21 | 2-Sided | 90 | -0.81 | 1.23 | Superiority |
| 3 hours postdose | Mixed Models Analysis | LS Mean | 0.53 | 2-Sided | 90 | -0.50 | 1.56 | Superiority |
| 3.5 hours postdose | Mixed Models Analysis | LS Mean | 1.36 | 2-Sided | 90 | 0.29 | 2.44 | Superiority |
| 4 hours postdose | Mixed Models Analysis | LS Mean | 1.21 | 2-Sided | 90 | 0.09 | 2.34 | Superiority |
| 6 hours postdose | Mixed Models Analysis | LS Mean | -0.49 | 2-Sided | 90 | -1.97 | 0.99 | Superiority |
| 8 hours postdose | Mixed Models Analysis | LS Mean | -0.36 | 2-Sided | 90 | -1.54 | 0.83 | Superiority |
| 12 hours postdose | Mixed Models Analysis | LS Mean | 0.73 | 2-Sided | 90 | -0.87 | 2.34 | Superiority |
| 24 hours postdose | Mixed Models Analysis | LS Mean | -0.12 | 2-Sided | 90 | -1.29 | 1.04 | Superiority |
| 30 minutes postdose |
|
| 1 hour postdose |
|
| 1.5 hours postdose |
|
| 2 hours postdose |
|
| 2.5 hours postdose |
|
| 3 hours postdose |
|
| 3.5 hours postdose |
|
| 4 hours postdose |
|
| 6 hours postdose |
|
| 8 hours postdose |
|
| 12 hours postdose |
|
| 24 hours postdose |
|