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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHX | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan | Experimental | Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan. | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
Participants must not be pregnant or nursing
Participants must not have any acute, serious, or unstable medical condition
Participants must not be on a medicine that acts in the brain and spinal cord
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perserverance Research Center | Scottsdale | Arizona | 85254 | United States | ||
| Newport Beach Clinical Research Associates, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33565026 | Derived | Tsai M, Nery ESM, Kerr L, Khanna R, Komori M, Dennehy EB, Wilbraham D, Winner P. Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine. Clin Pharmacokinet. 2021 Jun;60(6):819-828. doi: 10.1007/s40262-020-00966-z. Epub 2021 Feb 10. |
| Label | URL |
|---|---|
| A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine | View source |
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The 3-month open-label extension addendum was to evaluate safety and tolerability.
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 Milligrams (mg) Lasmiditan | Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan. |
| FG001 | 200 mg Lasmiditan | Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan. |
| FG002 | 50 mg Lasmiditan-Addendum | Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan. |
| FG003 | 100 mg Lasmiditan-Addendum | Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single-Dose Pharmacokinetic Study |
|
| ||||||||||||||||||
| Open-Label Addendum |
|
All randomized participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Lasmiditan | Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan. |
| BG001 | 200 mg Lasmiditan | Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose |
|
Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 mg Lasmiditan | Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: LAHX 05 Protocol | Mar 29, 2019 | Jul 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2019 | Jul 6, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol: LAHX Protocol Addendum (1.1) | Jun 11, 2019 | Jul 6, 2020 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Newport Beach |
| California |
| 92663 |
| United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Kurume Clinical Pharmacology Clinic | Kurume | Fukuoka | 830-0011 | Japan |
| Clinical Research Hospital, Tokyo | Shinjuku-Ku | Tokyo | 162-0053 | Japan |
| San Jorge Children and Women's Hospital- Shipping Location | San Juan | PR | 00912 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter(ng*hr/mL) | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | 200 mg Lasmiditan | Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | 50 mg Lasmiditan-Addendum | Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | 100 mg Lasmiditan-Addendum | Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan. | 0 | 2 | 0 | 2 | 1 | 2 |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| D009422 | Nervous System Diseases |