A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03988088
• Collaborator: (none)
• Enrollment: 18
• Locations: 11
• Arm: 1
• Actual Duration (Months): 7.1
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Lasmiditan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
• Actual Study Start Date: Jul 22, 2019
• Actual Primary Completion Date: Jan 19, 2020
• Actual Study Completion Date: Feb 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lasmiditan 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.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan [0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose]

   Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.

2. 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]

   PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perserverance Research Center	Scottsdale	Arizona	United States	85254
2	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California	United States	92663
3	New England Institute for Clinical Research	Stamford	Connecticut	United States	06905
4	Meridien Research	Bradenton	Florida	United States	34201
5	Meridien Research	Maitland	Florida	United States	32751
6	Qps-Mra, Llc	South Miami	Florida	United States	33143
7	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida	United States	33407
8	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
9	Kurume Clinical Pharmacology Clinic	Kurume	Fukuoka	Japan	830-0011
10	Clinical Research Hospital, Tokyo	Shinjuku-Ku	Tokyo	Japan	162-0053
11	San Jorge Children and Women's Hospital- Shipping Location	San Juan		Puerto Rico	00912

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

• Study Protocol: LAHX 05 Protocol - Mar 29, 2019
• Statistical Analysis Plan - Jul 15, 2019
• Study Protocol: LAHX Protocol Addendum (1.1) - Jun 11, 2019

More Information

Additional Information:

• A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03988088
• Other Study ID Numbers: 16932; H8H-MC-LAHX
• First Posted: Jun 17, 2019
• Last Update Posted: Sep 1, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Migraine Disorders; Lasmiditan

Study Results

Participant Flow

Pre-assignment Detail	The 3-month open-label extension addendum was to evaluate safety and tolerability.

Arm/Group Title	100 Milligrams (mg) Lasmiditan	200 mg Lasmiditan	50 mg Lasmiditan-Addendum	100 mg Lasmiditan-Addendum
Arm/Group Description	Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.	Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.	Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.	Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
Period Title: Single-Dose Pharmacokinetic Study
STARTED	11	7	0	0
COMPLETED	11	6	0	0
NOT COMPLETED	0	1	0	0
Period Title: Single-Dose Pharmacokinetic Study
STARTED	0	0	2	2
COMPLETED	0	0	1	2
NOT COMPLETED	0	0	1	0

Baseline Characteristics

Arm/Group Title	100 mg Lasmiditan	200 mg Lasmiditan	Total
Arm/Group Description	Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.	Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.	Total of all reporting groups
Overall Participants	11	7	18
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	9.09 (2.02)	14.00 (2.65)	11.00 (3.31)
Sex: Female, Male (Count of Participants)
Female	6 54.5%	6 85.7%	12 66.7%
Male	5 45.5%	1 14.3%	6 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 9.1%	1 14.3%	2 11.1%
Not Hispanic or Latino	5 45.5%	3 42.9%	8 44.4%
Unknown or Not Reported	5 45.5%	3 42.9%	8 44.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 45.5%	3 42.9%	8 44.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 45.5%	1 14.3%	6 33.3%
White	1 9.1%	3 42.9%	4 22.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	6 54.5%	4 57.1%	10 55.6%
Japan	5 45.5%	3 42.9%	8 44.4%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Description	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Time Frame	0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Arm/Group Title	100 mg Lasmiditan	200 mg Lasmiditan
Arm/Group Description	Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.	Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
Measure Participants	11	7
Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)]	362 (46.7)	426 (43.5)

2. Primary Outcome

Title	PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
Description	PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.
Time Frame	0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Arm/Group Title	100 mg Lasmiditan	200 mg Lasmiditan
Arm/Group Description	Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.	Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
Measure Participants	11	6
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter(ng*hr/mL)]	2050 (38.4)	2590 (13.7)

Adverse Events

Time Frame	Up To 3.5 Months
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug.
Arm/Group Title	100 mg Lasmiditan		200 mg Lasmiditan		50 mg Lasmiditan-Addendum		100 mg Lasmiditan-Addendum
Arm/Group Description	Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.		Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.		Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.		Participants with higher body weight (>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
All Cause Mortality
	100 mg Lasmiditan		200 mg Lasmiditan		50 mg Lasmiditan-Addendum		100 mg Lasmiditan-Addendum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/7 (0%)		0/2 (0%)		0/2 (0%)
Serious Adverse Events
	100 mg Lasmiditan		200 mg Lasmiditan		50 mg Lasmiditan-Addendum		100 mg Lasmiditan-Addendum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/7 (0%)		0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	100 mg Lasmiditan		200 mg Lasmiditan		50 mg Lasmiditan-Addendum		100 mg Lasmiditan-Addendum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)		5/7 (71.4%)		0/2 (0%)		1/2 (50%)
Eye disorders
Lacrimation increased	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Nausea	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
General disorders
Asthenia	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
Fatigue	0/11 (0%)	0	3/7 (42.9%)	4	0/2 (0%)	0	1/2 (50%)	2
Nervous system disorders
Ataxia	0/11 (0%)	0	2/7 (28.6%)	2	0/2 (0%)	0	0/2 (0%)	0
Disturbance in attention	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
Dizziness	1/11 (9.1%)	1	4/7 (57.1%)	5	0/2 (0%)	0	0/2 (0%)	0
Somnolence	2/11 (18.2%)	2	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Confusional state	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0
Irritability	0/11 (0%)	0	1/7 (14.3%)	1	0/2 (0%)	0	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.