An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Status: | Active, not recruiting |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | October 7, 2015 |
End Date: | September 20, 2019 |
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
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.
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.
Inclusion Criteria:
- Able and willing to give written informed consent and authorize Health Insurance
Portability and Accountability Act (HIPAA).
- Completed COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) within the
last 4 weeks.
- Females of child-bearing potential must be using or willing to use a highly effective
form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD),
abstinence or vasectomized partner).
- Able and willing to complete an electronic diary to record details of all migraine
attacks treated with study drug.
Exclusion Criteria:
- Any medical condition or clinical laboratory test which in the judgment of the
Investigator makes the subject unsuitable for the study.
- Pregnant or breast-feeding women.
- Women of child-bearing potential not using or not willing to use highly effective
contraception.
- Participant is at imminent risk of suicide (positive response to question 4 or 5 on
the Columbia Suicide Severity Rating Scale (C-SSRS).
- Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK
(NCT02605174).
- Participation in any clinical trial of an experimental drug or device since completing
EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
We found this trial at
181
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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