| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03670810 | A Study of Lasmiditan (LY573144) Over Four Migraine Attacks | PHASE3 | COMPLETED | 1,633 | — | — | Jun 24, 2019 | Jul 8, 2021 | Jul 29, 2022 | 141 | United States, Austria +15 |
| NCT03962738 | A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine | PHASE2 | COMPLETED | 846 | — | — | May 31, 2019 | Jun 8, 2020 | Jun 11, 2021 | 34 | Japan |
| NCT00384774 | A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine | PHASE2 | COMPLETED | 130 | — | — | Nov 1, 2006 | Jun 1, 2007 | Dec 2, 2019 | 3 | Finland, Germany +1 |
| NCT03988088 | A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine | PHASE1 | COMPLETED | 18 | — | — | Jul 22, 2019 | Feb 24, 2020 | Sep 1, 2020 | 11 | United States, Japan +1 |
| NCT03009162 | Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function | PHASE1 | COMPLETED | 16 | — | — | Apr 1, 2017 | Jun 2, 2017 | Dec 2, 2019 | 2 | Canada |
| NCT03076970 | Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants | PHASE1 | COMPLETED | 42 | — | — | Mar 21, 2017 | Apr 13, 2017 | Dec 2, 2019 | 1 | United States |
| NCT03040479 | Pharmacokinetic Single Dose Study of Oral Lasmiditan in Participants With Normal and Impaired Hepatic Function | PHASE1 | COMPLETED | 24 | — | — | Mar 14, 2017 | Jul 17, 2017 | Nov 27, 2019 | 3 | United States, Canada |
| NCT03012334 | The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants | PHASE1 | COMPLETED | 90 | — | — | Jan 16, 2017 | Jun 8, 2017 | Jan 10, 2020 | 1 | Canada |
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.
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 initiation of infusion of study drug.
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.
Maximum observed plasma concentration of lasmiditan.
Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value
Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC\[0- tlast\]) of lasmiditan.
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.
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. Variations in the lateral position are recorded and analyzed. SDLP, was analyzed using a mixed model with fixed effects for sequence, period, and treatment, and a random effect for participant within sequence. A variance component covariance structure and Kenward-Roger degrees of freedom was used.
| 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. |
| 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. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. |
| 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. |
| 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. |
| Lasmiditan 200 mg | EXPERIMENTAL | single oral tablet |
| 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. |
| Lasmiditan 100mg | EXPERIMENTAL | Participants received 100mg 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. |
| Lasmiditan 200mg | EXPERIMENTAL | Participants received 200mg of Lasmiditan tablets given as single 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. |
| Name | Type | Description |
|---|---|---|
| Lasmiditan | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| lasmiditan 200 mg | DRUG | drug including single placebo tablet |
| Sumatriptan | DRUG | drug including single placebo tablet |
| matching placebo | DRUG | single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet. |
| Alprazolam | DRUG | Active comparator based on treatment sequence in 5-way crossover |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |