Trials / Completed
CompletedNCT02565186
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,171 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lasmiditan | oral tablet |
Timeline
- Start date
- 2015-10-07
- Primary completion
- 2019-08-20
- Completion
- 2019-08-20
- First posted
- 2015-10-01
- Last updated
- 2020-08-25
- Results posted
- 2020-08-25
Locations
196 sites across 3 countries: United States, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02565186. Inclusion in this directory is not an endorsement.