MigrainePhase 1NCT03988088

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

A Phase 1 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Migraine
What is being tested?: Lasmiditan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 11 sitesin 3 countries
Study dates: 22 Jul 2019to 24 Feb 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

United States8 sites

Meridien Research
Bradenton, Florida, 34201
Meridien Research
Maitland, Florida, 32751
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Perserverance Research Center
Scottsdale, Arizona, 85254
Qps-Mra, Llc
South Miami, Florida, 33143
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407

Other trials in United States

Japan2 sites

Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, 830-0011
Clinical Research Hospital, Tokyo
Shinjuku-Ku, Tokyo, 162-0053

Other trials in Japan

Puerto Rico1 site

San Jorge Children and Women's Hospital- Shipping Location
San Juan, PR, 00912

Other trials in Puerto Rico

About this study

Official title: A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine

The study will last about 6 weeks, and includes 4 visits.

Conditions: Migraine
Being tested: Lasmiditan
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LasmiditanDrug
Also called LY573144
Administered orally.

Study groups in NCT03988088
Study group	Role	What they receive
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. Receives: Drug: Lasmiditan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201924 Feb 2020

First posted17 Jun 2019
Study start22 Jul 2019
Primary completion19 Jan 2020
Study completion24 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03988088
Sponsor's protocol ID: 16932
Other IDs: H8H-MC-LAHX
Status last verified: 1 May 2020
First submitted: 12 Jun 2019
Last updated: 1 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33565026

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
ClinicalTrials.gov ID: NCT03988088
Acronym / sponsor ID: 16932
Conditions: Migraine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 22 Jul 2019 (actual)
Primary completion: 19 Jan 2020 (actual)
Study completion: 24 Feb 2020 (actual)
First posted: 17 Jun 2019 (actual)
Results: Posted 1 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will last about 6 weeks, and includes 4 visits.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lasmiditan	Experimental	Drug: LasmiditanParticipants 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.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LasmiditanAlso: LY573144Administered orally.	Drug	Lasmiditan

Primary outcome

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

Results and safety

Results posted to the registry on 1 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
100 Milligrams (mg) Lasmiditan	11	11
200 mg Lasmiditan	7	6
50 mg Lasmiditan-Addendum	0	0
100 mg Lasmiditan-Addendum	0	0

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	100 mg Lasmiditan n = 11	200 mg Lasmiditan n = 7
Value	362 (46.7)	426 (43.5)

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

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter(ng*hr/mL)

Measure	100 mg Lasmiditan n = 11	200 mg Lasmiditan n = 6
Value	2050 (38.4)	2590 (13.7)

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

Adverse events

Time frame: Up To 3.5 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
100 mg Lasmiditan	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
200 mg Lasmiditan	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
50 mg Lasmiditan-Addendum	0 of 2 (0%)	0 of 2 (0%)	0 of 2
100 mg Lasmiditan-Addendum	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33565026Tsai 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.
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With MigraineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

11 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03988088, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.