Migraine
Conditions
Keywords
acute
Brief summary
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
Interventions
DRUGLasmiditan
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have 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 * Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator * Participant must be able to swallow a tablet * For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening * Participants must weigh at least 15 kilograms (kg)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose | 2 hours post dose | Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups) | 2 hours post-dose | Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome. |
| Percentage of Participants With Pain Relief at 2 Hours Post-Dose | 2 hours post-dose | Pain relief at 2 hours post-dose was defined as a pain intensity of none or mild at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain from moderate (Faces 3 and 4) or severe (Face 5) to mild or no pain (Face 1 or 2) or patient is asleep were considered to have pain relief. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome. |
| Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose | 2 hours post-dose | MBS freedom was defined as MBS reported before dosing that was absent post-dose. MBS included nausea, photophobia, or phonophobia. MBS were measured using a binary scale (Yes/No) using electronic diary (e-Diary) at 2-hours post-dose. Participants who captured as "No" (MBS absent) were considered to have freedom from MBS. |
| Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose | 2 hours post-dose | Nausea status was measured as absent or present in the e-Diary. Freedom from nausea was defined as nausea absent. Participants who captured as "No" (Nausea absent) were considered to have freedom from nausea. |
| Percentage of Participants With Freedom From Photophobia at 2 Hours Post-Dose | 2 hours post-dose | Photophobia (sensitivity to light) status was measured as absent or present in the e-Diary. Freedom from photophobia was defined as photophobia absent. Participants who captured as "No" (Photophobia absent) were considered to have freedom from photophobia. |
| Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-Dose | 2 hours post-dose | Phonophobia (sensitivity to sound) status was measured as absent or present in the e-Diary. Freedom from phonophobia was defined as phonophobia absent. Participants who captured as "No" (phonophobia absent) were considered to have freedom from phonophobia. |
| Percentage of Participants With Sustained Pain Freedom From 2 Through 24 Hours Post-Dose | 2 through 24 hours post-dose | Sustained pain freedom from 2 through 24 hours post-dose was defined as a pain intensity of none at all time points with 24 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 24 hours post-dose with no use of rescue medication or no relapse within the 24 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome. |
| Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose | 2 through 24 hours post-dose | Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free). |
| Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose | 2 through 48 hours post-dose | Sustained pain freedom from 2 through 48 hours post-dose was defined as a pain intensity of none at all time points with 48 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 48 hours post-dose with no use of rescue medication or no relapse within the 48 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome. |
| Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 48 Hours Post-Dose | 2 through 48 hours post-dose | Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free). |
| Percentage of Participants With No Disability at 2 Hours Post-Dose | 2 hours post-dose | Disability was assessed by the level of interference with normal activities using an electronic diary. Participants rated how much their migraine interfered with usual activities (e.g., play, schoolwork, or other work) using a 4 point numeric rating scale, where 0 = not at all, 1 = a little, 2 = a lot, and 3 = complete interference (required bed rest). No Disability was defined as the first time point at which a score of 0 (no interference) was reported. 4-Point Numeric Rating Scale; minimum value: 0 (not at all); maximum value: 3 (complete interference/bed rest required); higher scores indicate worse outcome. Percentages for each response category were estimated using a repeated-measures logistic mixed-effects model (treatment + time + age group + treatment\*time + preventive treatment), not as a simple count divided by the Overall Number of Participants Analyzed (N). As a result, individual percentages may not correspond to a whole number of participants out of N. |
| Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose | 24 hours post-dose | Acceptability of the lasmiditan oral formulation (single tablet) was assessed using an electronic diary at the 24 hour post dose assessment. Participants were asked to report their experience of swallowing the study medication by responding to the question: "Think about the experience of swallowing the study medicine. How easy or hard was it for you to swallow one of the pills?" Responses were recorded on a 5 point ordinal scale: Very easy, Easy, Neither easy nor hard, Hard, or Very hard. 5-Point Ordinal Scale; minimum value: 1 (Very Easy); maximum value: 5 (Very Difficult); higher scores indicate worse outcome. |
Countries
Belgium, Canada, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Romania, Russia, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Pre-assignment details
A participant who was randomly assigned but did not treat a qualifying migraine with the study drug was considered to have completed the study if the participant did not discontinue during the 12-week treatment period (stage 1 and stage 2) and attended the End of Study visit, as pre-specified in the protocol.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 13.40 years STANDARD_DEVIATION 2.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 387 Participants |
| Region of Enrollment Belgium | 2 Participants |
| Region of Enrollment Canada | 0 Participants |
| Region of Enrollment France | 0 Participants |
| Region of Enrollment Germany | 1 Participants |
| Region of Enrollment India | 14 Participants |
| Region of Enrollment Italy | 3 Participants |
| Region of Enrollment Japan | 26 Participants |
| Region of Enrollment Mexico | 9 Participants |
| Region of Enrollment Netherlands | 10 Participants |
| Region of Enrollment Romania | 1 Participants |
| Region of Enrollment Russia | 0 Participants |
| Region of Enrollment Spain | 5 Participants |
| Region of Enrollment United Kingdom | 15 Participants |
| Region of Enrollment United States | 66 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 0 / 104 | 0 / 121 | 0 / 103 | 0 / 328 |
| other Total, other adverse events | 15 / 298 | 13 / 104 | 25 / 121 | 21 / 103 | 59 / 328 |
| serious Total, serious adverse events | 0 / 298 | 0 / 104 | 1 / 121 | 1 / 103 | 2 / 328 |
Outcome results
None listed