A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2
- Conditions
- Headachemigraine10019231
- Registration Number
- NL-OMON49166
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
Type of Patient and Disease Characteristics
[1] Patient is at least 6 and less than 18 years of age at Screening (Visit 1).
[2] Patient must have a minimum body weight of 15 kg.
[3] Patient has a history of migraine with or without aura as defined by
International Headache Society International Classification of Headache
Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or
1.2.1 and meets the following criteria:
- History of migraine attacks for more than 6 months
- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per
month in the 2 months prior to Screening Visit
- Duration of a typical untreated migraine attack (excluding sleep) is greater
than or
equal to*3 hours
- Patient has not, by history, experienced satisfactory response with a previous
migraine therapy, in the opinion of the investigator.
[4] Patient must be able to swallow a tablet.
[5] For patients taking migraine preventive medication, treatment regimen is
stable and has been taken for at least 3 months prior to Visit 1.
Informed Consent and Patient Agreements
[6] The patient and patient*s parent or guardian must understand the nature of
the
study. The patient*s parent or guardian must sign an ICF, and the patient must
sign an informed assent document as required by local regulations.
[7] The patient and patient*s parent or guardian are reliable and willing to
make
themselves available for the duration of the study and are willing to follow
study procedures.
[8] Patient is male or female; if female, must agree to abide by the following
guidance:
- Females of childbearing potential (started menses, to include any duration or
amount of spotting) must agree to use a highly effective method of contraception
(that is, one with less than 1% failure rate) such as
o combination oral contraceptives
o implanted/injected contraceptives
o intrauterine devices, or
o sterile partner until 30 days after the last dose of study medication.
- Females of childbearing potential who are abstinent (if this is complete
abstinence,
as their preferred and usual lifestyle) or in a same-sex relationship (as part
of their
preferred and usual lifestyle) must agree to either remain abstinent or stay in
a
same-sex relationship without sexual relationships with males. Periodic
abstinence
(for example, calendar, ovulation, symptothermal, and postovulation methods),
declaration of abstinence just for the duration of a trial, and withdrawal are
not
acceptable methods of contraception.
[9] The patient and patient*s parent or guardian must agree not to post any
personal medical data related to the study or information related to the study
on any website or social media site until notification that the study has been
completed. Examples of these sites include
- Facebook
- Twitter
- Snapchat
- Instagram, and
- Google+.
Medical Conditions
[10] Patient has a history or clinical evidence of congenital heart disease,
suspected
or confirmed.
[11] ECG showing abnormalities compatible with acute cardiovascular events,
serious cardiovascular disease risk, or both.
[12] Within 6 months of screening, patient had
- myocardial infarction
- unstable angina
- percutaneous coronary intervention, and
- coronary artery bypass graft.
[13] Patient has planned cardiovascular surgery or percutaneous coronary
angioplasty, or has a history of stroke.
[14] Patient has any liver tests outside the normal range at screening that are
clinically
significant. Alanine aminotransferase (ALT) greater than 2x upper limit of
normal
(ULN), or total bilirubin level (TBL) greater than 1.5x ULN, or alkaline
phosphatase
(ALP) greater than 2x ULN must be discussed and judged not clinically
significant by
Lilly Medical prior to enrollment.
NOTE: Patients with TBL at least 1.5x ULN are not excluded if they meet all of
the
following criteria for Gilbert syndrome:
*- Bilirubin is predominantly indirect (unconjugated) at Screening (direct
bilirubin within normal limits)
* - Absence of liver disease
* - ALT, aspartate aminotransferase (AST), and ALP no greater than 1x ULN at
screening, and
* Hemoglobin not significantly decreased at screening.
[15] Patient has, in the judgement of the investigator, a psychiatric disorder
as
defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th
Edition, that would interfere with adherence to study requirements or safe
participation in the trial. This includes a current or historical diagnosis of a
substance use disorder.
[16] Patient is, in the judgment of the investigator, actively suicidal and
therefore
deemed to be at significant risk for suicide.
[17] At Screening:
- patient has answered *yes* to either Question 4 or Question 5 on the *Suicidal
Ideation* portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or has
answered *yes* to any of the suicide-related behaviors on the *suicidal
behavior*
portion of the C-SSRS, and
- the ideation or behavior occurred within the past month.
[18] Patient is pregnant or breastfeeding.
[19] Patient has, in the judgment of the investigator, an acute, serious, or
unstable
medical condition or a history or presence of any other medical illness that
would preclude study participation.
Prior and Concomitant Therapy/Substances of Abuse
[20] Patient has used opioids or barbiturate-containing analgesic more than 3
times
per month for the treatment of pain in more than 2 of the past 6 months.
[21] Patient has known allergies to lasmiditan, related compounds, or any
components of the formulation.
[22] Patient has a positive urine drug screen for any substances of abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Nature, proportion, and severity of TEAEs by treated attack.<br /><br>- Proportion of discontinuation due to AEs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of treated attacks with pain freedom at 2 hours after dosing for<br /><br>each 3-month period.<br /><br>- Proportion of treated attacks with pain relief at 2 hours after dosing for<br /><br>each 3-month period.<br /><br>- Proportion of treated attacks with freedom of the most bothesome symptom, at<br /><br>2 hours after dosing for each 3-month period.</p><br>