Lasmiditan
DrugAdministered orally
Other names: LY573144
NCT Number: NCT03962738
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Takanoko Hospital, Matsuyama, Ehime, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Other names: LY573144
Administered orally
Time frame: 2 Hours Postdose
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose.
Missing value at a particular time point was considered as "nonresponder."
Time frame: 24 Hours Postdose
Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Time frame: 48 Hours Postdose
Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Time frame: 2 Hours Postdose
Percentage of participants that are free of phonophobia at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants that are free of photophobia at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants that are free of nausea at 2 hours postdose.
Time frame: 2 Hours Postdose
Percentage of participants that are free of vomiting at 2 hours postdose.
Time frame: 1 Hour Postdose
Percentage of participants with pain freedom.
Time frame: 1 Hour Postdose
Percentage of participants with headache pain relief at 1 hour postdose.
Time frame: 1 Hour Postdose
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.
Time frame: 1 Hour Postdose
Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.
Percentage of participants who are responders defined as score = 0 at 1 hours postdose.
Time frame: 2 Hours Postdose
Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.
Percentage of participants who are responders defined as score = 0 at 2 hours postdose.
Time frame: Baseline, 24 Hours Postdose
The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.
Time frame: Baseline, 24 Hours Postdose
The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: 2 Hours Postdose
The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.
Time frame: 24 Hours Postdose
The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.
Eli Lilly and Company
Industry
RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study
Acronym: MONONOFU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04530110
Brain Diseases, Central Nervous System Diseases
Aurora, Colorado, United States
View Trial DetailsNCT07699549
Brain Diseases, Central Nervous System Diseases
Madrid, Spain
View Trial DetailsNCT07720895
Brain Diseases, Central Nervous System Diseases
Athens, Greece
View Trial DetailsNCT06158737
Brain Diseases, Central Nervous System Diseases
Beijing, Beijing Municipality, China
View Trial Details