Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lasmiditan · 27 trials · 7 indications
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
PK: Cmax of Lasmiditan.
PK: AUC\[0-inf\] of Lasmiditan.
PK: AUC\[0-tlast\] of Lasmiditan.
PK: Cmax of Dabigatran.
PK: Cmax of Rosuvastatin.
PK: AUC\[0-∞\] of Dabigatran
PK: AUC\[0-∞\] of Rosuvastatin
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant.
Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares (LS) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.
The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.
Change from baseline in mean hourly heart rate recorded as beats per minute and collected by Holter ambulatory monitoring in response to propranolol administered alone and in combination with lasmiditan.
PK: Cmax of Lasmiditan in Each Period.
PK: AUC(0-∞) of Lasmiditan in Each Period.
Area under the concentration versus time curve from zero to infinity
Maximum observed concentration based on plasma concentrations of lasmiditan.
Time to maximum concentration based on plasma concentrations of lasmiditan.
Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.
AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.
AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.
Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC\[0-inf\]) of lasmiditan.
Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)
Fraction of dose excreted in urine (Ae / dose)
Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record.
Maximum observed plasma concentration.
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
Terminal elimination half-life, calculated as ln(2)/λZ.
This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
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.
| Arm | Type | Description |
|---|---|---|
| 100 milligram (mg) Lasmiditan | EXPERIMENTAL | Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| 200 mg Lasmiditan | EXPERIMENTAL | Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| Control 1 Sequence | PLACEBO_COMPARATOR | Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| Control 2 Sequence | PLACEBO_COMPARATOR | Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| 100 mg Lasmiditan Maximum Extended Enrollment (MEE) | EXPERIMENTAL | Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| 200 mg Lasmiditan MEE | EXPERIMENTAL | Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| Control 1 Sequence MEE | PLACEBO_COMPARATOR | Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| Control 2 Sequence MEE | PLACEBO_COMPARATOR | Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks. |
| Open Label Extension | EXPERIMENTAL | Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability. |
| Lasmiditan 50 milligram (mg) | EXPERIMENTAL | Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. |
| Lasmiditan 100 mg | EXPERIMENTAL | Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. |
| Lasmiditan 200 mg | EXPERIMENTAL | Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. |
| Placebo | PLACEBO_COMPARATOR | Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. |
| Lasmiditan 100mg | EXPERIMENTAL | Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. |
| Lasmiditan 200mg | EXPERIMENTAL | Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. |
| 50 milligram (mg) Lasmiditan | EXPERIMENTAL | 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. |
| 100 mg Lasmiditan | EXPERIMENTAL | 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. |
| 50 mg Lasmiditan | EXPERIMENTAL | 50 mg lasmiditan administered orally (PO) |
| 400 mg Lasmiditan | EXPERIMENTAL | 400 mg lasmiditan administered orally (PO) |
| Lasmiditan | EXPERIMENTAL | Participants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection. |
| 100 milligram (mg) Lasmiditan immediate release (IR) (Reference) | ACTIVE_COMPARATOR | Participants received 100 mg lasmiditan as IR tablet formulation administered orally. |
| 100 mg Lasmiditan oral disintegrating (OD) Without Water (Test) | EXPERIMENTAL | Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water. |
| 100 mg Lasmiditan OD With Water (Test) | EXPERIMENTAL | Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water. |
| 150 Milligram (mg) Dabigatran Etexilate + 200mg Lasmiditan - Part 1 | EXPERIMENTAL | Participants received 150 mg dabigatran etexilate on Day 1 followed by 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally |
| 10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2 | EXPERIMENTAL | Participants received 10 mg rosuvastatin on Day 1 followed by 200 mg lasmiditan QD on Days 8 and 9, and 10 mg of rosuvastatin along with 200 mg lasmiditan on Day 10. All treatments were administered orally. |
| Lasmiditan - Japanese | EXPERIMENTAL | Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods. |
| Placebo - Japanese | PLACEBO_COMPARATOR | Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods. |
| Lasmiditan - Caucasian | EXPERIMENTAL | Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods. |
| Placebo - Caucasian | PLACEBO_COMPARATOR | Single dose of Placebo administered orally in up to one of three study periods. |
| 100 milligrams (mg) Lasmiditan | EXPERIMENTAL | 100 mg lasmiditan administered orally in one of four study periods. |
| Diphenhydramine | ACTIVE_COMPARATOR | 50 mg diphenhydramine administered orally in one of four study periods. |
| Lasmiditan 200 mg (milligrams) | EXPERIMENTAL | Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliter) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
| Lasmiditan + Sumatriptan (A) | EXPERIMENTAL | Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods. |
| Lasmiditan + Placebo (B) | EXPERIMENTAL | Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods. |
| Sumatriptan + Placebo (C) | ACTIVE_COMPARATOR | Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods. |
| Placebo + Placebo (D) | PLACEBO_COMPARATOR | Oral doses of placebo tablets in one of four treatment periods. |
| Lasmiditan Alone | EXPERIMENTAL | Lasmiditan administered orally, alone |
| Placebo Alone | PLACEBO_COMPARATOR | Placebo administered orally, alone |
| Topiramate + Lasmiditan | EXPERIMENTAL | Topiramate administered orally, alone, and co-administered with oral lasmiditan |
| Topiramate + Placebo | EXPERIMENTAL | Topiramate administered orally, alone, and co-administered with oral placebo |
| Alprazolam 2 milligram (mg) | ACTIVE_COMPARATOR | 2 mg of alprazolam was administered orally in one of five treatment periods |
| Lasmiditan 400 mg | EXPERIMENTAL | 400 mg of lasmiditan was administered orally in one of five treatment periods |
| Lasmiditan Reference | EXPERIMENTAL | Single oral dose of lasmiditan 200 mg on Day 1 as reference treatment. |
| Propranolol Reference | ACTIVE_COMPARATOR | Twice-daily oral doses of propranolol 80 mg on Days 4-10 as reference treatment. |
| Lasmiditan + Propranolol Test | EXPERIMENTAL | Single oral dose of lasmiditan 200 mg + two oral doses of propranolol 80 mg on Day 9 as test treatment. |
| Lasmiditan (Period 1) | EXPERIMENTAL | 200 mg Lasmiditan tablet given once orally during migraine attack. |
| Lasmiditan (Period 2) | EXPERIMENTAL | 200 mg Lasmiditan tablet given once orally during inter-ictal period. |
| 200 mg Lasmiditan (Group 1 Elderly) | EXPERIMENTAL | 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods. |
| Placebo (Group 1 Elderly) | PLACEBO_COMPARATOR | Placebo on Day 1 of 1 of 2 dosing periods. |
| 200 mg Lasmiditan (Group 2 Young) | EXPERIMENTAL | 200 mg lasmiditan on Day 1. |
| [14C]-lasmiditan | EXPERIMENTAL | \[14C\]-lasmiditan administered as a 200 mg (approximately 100 µCi) oral solution |
| Renal impaired participants | EXPERIMENTAL | Participants received single 200 milligrams (mg) oral tablet of lasmiditan. |
| Healthy participants | EXPERIMENTAL | Participants received single 200 mg oral tablet of lasmiditan. |
| Sumatriptan 100 mg | ACTIVE_COMPARATOR | single oral tablet |
| Combination of lasmiditan and sumatriptan | EXPERIMENTAL | single oral tablet of each |
| Mild hepatic impairment | EXPERIMENTAL | lasmiditan 200 mg single dose |
| Moderate hepatic impairment | EXPERIMENTAL | lasmiditan 200 mg single dose |
| Lasmiditan 50mg (milligrams) | EXPERIMENTAL | Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. |
| Alprazolam 1mg | ACTIVE_COMPARATOR | Participants received 1mg of Alprazolam tablets as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. |
| Group A | EXPERIMENTAL | Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2 |
| Group B | EXPERIMENTAL | Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2. |
| Moxifloxacin | ACTIVE_COMPARATOR | A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods. |
| Name | Type | Description |
|---|---|---|
| Lasmiditan | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| Lasmiditan 50 mg | DRUG | One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses) |
| Lasmiditan 100 mg | DRUG | One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses) |
| Lasmiditan 200 mg | DRUG | One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses) |
| Placebo (matches lasmiditan doses) | DRUG | - |
| Dabigatran Etexilate | DRUG | Administered orally. |
| Rosuvastatin | DRUG | Administered orally. |
| Diphenhydramine | DRUG | Administered orally |
| Sumatriptan | DRUG | Administered orally |
| Placebo for Lasmiditan | DRUG | Administered orally |
| Placebo for Sumatriptan | DRUG | Administered orally |
| Topiramate | DRUG | Administered orally |
| Alprazolam | DRUG | Administered orally |
| Propranolol | DRUG | Administered orally |
| [14C]-lasmiditan | DRUG | \[14C\]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution |
| matching placebo | DRUG | single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet. |
| Moxifloxacin | DRUG | 400 mg moxifloxacin administered PO |
Inclusion Criteria: * Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 * History of disabling migraine for at least 1 year * Migraine onset before the age of 50 years * History of 3 to 8 migraine attacks per month (\<15 headache day...
Lasmiditan is used for the acute treatment of migraine, including migraine with or without aura. It is an investigational small molecule being developed for neurology, specifically for acute migraine attacks. The drug is administered to relieve migraine symptoms and is currently in Phase 3 clinical development.
Lasmiditan targets the serotonin 5-HT1F receptor, which is distinct from other migraine treatments that target 5-HT1B/1D receptors. By selectively activating 5-HT1F receptors, it is thought to inhibit trigeminal nerve activation and reduce neurogenic inflammation associated with migraine, without causing vasoconstriction.
Lasmiditan is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. Eli Lilly is conducting clinical trials to evaluate the safety and efficacy of Lasmiditan for the acute treatment of migraine.
Lasmiditan is in Phase 3 clinical development. It has completed 13 clinical trials, including a Phase 3 study comparing Lasmiditan to placebo in the acute treatment of migraine. The drug is investigational and has not yet been approved by regulatory authorities.
Lasmiditan has been studied in 13 completed clinical trials. Key trials include NCT02439320, a Phase 3 study in 2,231 participants with acute migraine, and NCT02233296, a food-effect study in healthy participants. Other trials include NCT03286218, an abuse potential study, and NCT03459612, a driving performance study.
Lasmiditan is the generic name for the drug also known as Reyvow. Reyvow is the brand name under which Eli Lilly markets Lasmiditan for the acute treatment of migraine with or without aura. Both names refer to the same active pharmaceutical ingredient.