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A Study of Lasmiditan in Participants With Migraine
Phase 1 trial testing Lasmiditan in Migraine Disorders in 16 participants. Completed in 15 January 2018.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 16 |
| Start date | 16 August 2017 |
| Primary completion | 15 January 2018 |
| Estimated completion | 15 January 2018 |
| Sites | 3 locations across United States |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Migraine Disorders. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PK: Cmax of Lasmiditan in Each Period.
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 233 | ± 47 |
| Lasmiditan (Period 2) | 227 | ± 44 |
PK: AUC(0-∞) of Lasmiditan in Each Period.
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 1570 | ± 43 |
| Lasmiditan (Period 2) | 1640 | ± 46 |
PK: Cmax of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 14.5 | ± 54 |
| Lasmiditan (Period 2) | 14.8 | ± 41 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 319 | ± 34 |
| Lasmiditan (Period 2) | 326 | ± 30 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 77.2 | ± 52 |
| Lasmiditan (Period 2) | 85.9 | ± 42 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 57.0 | ± 31 |
| Lasmiditan (Period 2) | 59.5 | ± 34 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 14.0 | ± 37 |
| Lasmiditan (Period 2) | 15.0 | ± 27 |
PK: AUC(0-∞) of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 68.0 | ± 44 |
| Lasmiditan (Period 2) | 77.8 | ± 33 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 6180 | ± 28 |
| Lasmiditan (Period 2) | 6380 | ± 27 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 820 | ± 80 |
| Lasmiditan (Period 2) | 949 | ± 60 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 1460 | ± 33 |
| Lasmiditan (Period 2) | 1570 | ± 34 |
| Group | Value | 95% CI |
|---|---|---|
| Lasmiditan (Period 1) | 363 | ± 29 |
| Lasmiditan (Period 2) | 318 | ± 24 |
Time frame: Up To 58 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lasmiditan (Period 1) | Lasmiditan (Period 2) |
|---|---|---|---|
| Migraine | Nervous system disorders | — | — |
| Photophobia | Eye disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Phonophobia | Psychiatric disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Flushing | Vascular disorders | — | — |
| Vulvovaginitis | Infections and infestations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Blood urea increased | Investigations | — | — |
| Electrocardiogram QT prolonged | Investigations | — | — |
| Electrocardiogram T wave abnormal | Investigations | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Lethargy | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — |
| Orthostatic hypotension | Vascular disorders | — | — |
Data from ClinicalTrials.gov NCT03247790 adverse events section.
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks. Information about any side effects that may occur will also be collected. This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening). Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study. This study is for research purposes only and is not intended to treat any medical condition.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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