Migraine Clinical Trial
Official title:
A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
| Verified date | May 1, 2020 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is the measure the levels of lasmiditan in the body of children aged
6 to 17 with migraine. The study also will also examine the safety and tolerability of
lasmiditan in children aged 6 to 17 with migraine.
The study will last about 6 weeks, and includes 4 visits.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | February 24, 2020 |
| Est. primary completion date | January 19, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Participants must have a history of migraine headaches for more than 6 months - Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months - Participants must weigh between 15 and 55 kilograms (kg) - Participants must not have a migraine headache on the day of lasmiditan administration Exclusion Criteria: - Participants must not be pregnant or nursing - Participants must not have any acute, serious, or unstable medical condition - Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator - Participants must not be on a medicine that acts in the brain and spinal cord |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kurume Clinical Pharmacology Clinic | Kurume | Fukuoka |
| Japan | Clinical Research Hospital, Tokyo | Shinjuku-Ku | Tokyo |
| Puerto Rico | San Jorge Children and Women's Hospital- Shipping Location | San Juan | |
| United States | Meridien Research | Bradenton | Florida |
| United States | Meridien Research | Maitland | Florida |
| United States | Newport Beach Clinical Research Associates, Inc. | Newport Beach | California |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Perserverance Research Center | Scottsdale | Arizona |
| United States | Qps-Mra, Llc | South Miami | Florida |
| United States | New England Institute for Clinical Research | Stamford | Connecticut |
| United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Japan, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan. | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose | |
| Primary | PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-8]) of Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-8]) of Lasmiditan. | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose |
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