NCT03308669

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

Completed Phase 1 Results posted Last updated 27 November 2019

What this trial tests

Phase 1 trial testing Lasmiditan in Healthy in 30 participants. Completed in 2 December 2017.

Timeline

16 October 2017

Primary endpoint
2 December 2017

2 December 2017

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	30
Start date	16 October 2017
Primary completion	2 December 2017
Estimated completion	2 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Lasmiditan (LASMIDITAN) — full drug profile →
• Placebo
• Topiramate (topiramate) — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Primary · Baseline through Day 24

A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Group	Value	95% CI
Placebo	0
200 mg Lasmiditan	0
Topiramate Alone	0
50 mg Topiramate + 200 mg Lasmiditan	0
50 mg Topiramate + Placebo	0

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 Secondary · Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14

Group	Value	95% CI
50 mg Topiramate	4300	± 15
50 mg Topiramate + 200 mg Lasmiditan	4190	± 16

PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 Secondary · Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14

Group	Value	95% CI
200 mg Lasmiditan	276	± 41
50 mg Topiramate + 200 mg Lasmiditan	301	± 35

PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 Secondary · Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC \[tau\]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14

Group	Value	95% CI
50 mg Topiramate	42600	± 15
50 mg Topiramate + 200 mg Lasmiditan	42800	± 17

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 Secondary · Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14

Group	Value	95% CI
200 mg Lasmiditan	1860	± 29
50 mg Topiramate + 200 mg Lasmiditan	2050	± 29

Adverse events — posted to ClinicalTrials.gov

Time frame: Up To 24 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200 mg Lasmiditan

Serious: 0/20 (0%)

Deaths: 0/20

Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Topiramate Alone

Serious: 0/30 (0%)

Deaths: 0/30

50 mg Topiramate + 200 mg Lasmiditan

Serious: 0/20 (0%)

Deaths: 0/20

50 mg Topiramate + Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (8 terms — click to expand)

Reaction	System	200 mg Lasmiditan	Placebo	Topiramate Alone	50 mg Topiramate + 200 mg …	50 mg Topiramate + Placebo
Dizziness	Nervous system disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Scratch	Injury, poisoning and procedural complications	—	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—	—
Euphoric mood	Psychiatric disorders	—	—	—	—	—
Lip dry	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Depressed mood	Psychiatric disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03308669 adverse events section.

Sponsor's own description

This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected.

Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.

This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Serotonin receptor agonists in the acute treatment of migraine: a review on their therapeutic potential.
   Negro A, Koverech A, Martelletti P. · · 2018 · cited 57× · PMID 29563831 · DOI 10.2147/jpr.s132833
2. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials.
   Loo LS, Ailani J, Schim J, Baygani S, et al · · 2019 · cited 29× · PMID 31340760 · DOI 10.1186/s10194-019-1032-x