Acute MigrainePhase 3NCT04218162
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in Korean
A Phase 3 study testing Lasmiditan 50mg and Lasmiditan 100mg in people with Acute Migraine, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Migraine
- What is being tested?
- Lasmiditan 50mg and Lasmiditan 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2020to 30 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Male or female, aged 18 years or above.
- Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD-3).
- History of disabling migraine for at least 1 year.
- Migraine Disability Association (MIDAS) score ≥11.
- Migraine onset before the age of 50 years.
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- History of 3 - 8 migraine attacks per month (< 15 headache days per month).
- Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
- Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.
Who cannot join
- Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
- Pregnant or breast-feeding women.
- Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
- History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
- History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
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- History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
- History of orthostatic hypotension with syncope.
- Significant renal or hepatic impairment.
- Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
- Participation in any clinical trial of an experimental drug or device in the previous 30 days.
- Known Hepatitis B or C or human immunodeficiency virus(HIV) infection. History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
- Use of more than 3 doses per month of either opiates or barbiturates.
- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate Efficacy and Safety of Lasmiditan Compared to Placebo in the Acute Treatment of Migraine
A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine
- Conditions
- Acute Migraine
- Being tested
- Lasmiditan 50mg, Lasmiditan 100mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lasmiditan 50mgDrug
Lasmiditan 50mg
Lasmiditan 100mgDrug
Lasmiditan 100mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lasmiditan 50mg | Experimental | Not described Receives: Drug: Lasmiditan 50mg |
| Lasmiditan 100mg | Experimental | Not described Receives: Drug: Lasmiditan 100mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Measured: 2 hours post dose
Secondary outcomes (5)
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Measured: 2 hours post dose
Percentage of Participants With Headache Relief
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Measured: 2 hours post dose
Number of Participants With Headache Recurrence
The number of participants with headache recurrence
Measured: 2 Hours Post Dose Up to 48 Hours
Percentage of Participants Use of Rescue Medication
The percentage of participants who used rescue medication.
Measured: From 2 Hours Post Dose Up to 24 Hours
Number of Participants With Treatment Emergent Adverse Events
Safety and tolerability was assessed by the number of participants with at least 1 treatment adverse emergent event.
Measured: From Baseline Up to End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start24 Mar 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218162
- Sponsor's protocol ID
- ID-LAS-301
- Status last verified
- Mar 2021
- First submitted
- 2 Jan 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate Efficacy and Safety of Lasmiditan Compared to Placebo in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04218162
- Acronym / sponsor ID
- ID-LAS-301
- Conditions
- Acute Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lasmiditan 50mg | Experimental | Drug: Lasmiditan 50mg |
| Lasmiditan 100mg | Experimental | Drug: Lasmiditan 100mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to give written informed consent.
- Male or female, aged 18 years or above.
- Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD-3).
- History of disabling migraine for at least 1 year.
- Migraine Disability Association (MIDAS) score ≥11.
Key exclusion criteria (14 listed)
- Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
- Pregnant or breast-feeding women.
- Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
- History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
- History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
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 |
|---|---|---|
| Lasmiditan 50mgLasmiditan 50mg | Drug | Lasmiditan 50mg |
| Lasmiditan 100mgLasmiditan 100mg | Drug | Lasmiditan 100mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Time frame: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
5 secondary outcomes
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
Time frame: 2 hours post dose
Percentage of Participants With Headache Relief
Time frame: 2 hours post dose
Number of Participants With Headache Recurrence
Time frame: 2 Hours Post Dose Up to 48 Hours
Percentage of Participants Use of Rescue Medication
Time frame: From 2 Hours Post Dose Up to 24 Hours
Number of Participants With Treatment Emergent Adverse Events
Time frame: From Baseline Up to End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lasmiditan 50mg and Lasmiditan 100mg in people with Acute Migraine, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
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 9 inclusion and 14 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants Headache Pain Free at 2 Hours Post Dose (time frame: 2 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2021.