asmiditan study on patients Over Four Migraine Attacks

Phase 3

Completed

• Conditions: Health Condition 1: G431- Migraine with aura

• Registration Number: CTRI/2019/05/019167
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-18
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

[1] are of an acceptable age to provide informed consent according to the local regulations

and are at least 18 years of age at time of screening (Visit 1) with migraine with or

without aura fulfilling the IHS diagnostic criteria 1.1 or 1.2.1

[2] history of disabling migraine for at least 1 year

[3] migraine onset before the age of 50 years

[4] history of 3 to 8 migraine attacks per month ( <15 headache days per month) during the

past 3 months

[5] MIDAS score �11

[6] able and willing to complete an eDiary to record the details of each migraine attack

treated with study drug

[7] are men or women; if women, must agree to abide by the following guidance:

women of child-bearing potential must agree to use a highly effective method of

contraception (that is, one with less than 1% failure rate) such as combination oral

contraceptives, implanted/injected contraceptives, intrauterine devices, or sterile partner

until 30 days after the last dose of study medication

Exclusion Criteria

[1] known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets

[2] history or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the

patient at increased risk of seizures

[3] history of recurrent dizziness and/or vertigo including benign paroxysmal positional

vertigo, Meniereââ?¬•s disease, vestibular migraine, and other vestibular disorders

[4] history of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)

[5] history of orthostatic hypotension with syncope

[6] significant renal or hepatic impairment in the opinion of the investigator or if they meet

hepatic monitoring criteria

[7] history, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is �15 headache days per month

[8] use of more than 3 doses per month of either opioids or barbiturates

[9] initiation of or a change in concomitant medication to reduce the frequency of migraine

episodes within 3 months prior to Screening/Visit 1

[10] female patients who are pregnant or breast-feeding

[11] women of child-bearing potential who test positive for pregnancy based on a serum pregnancy test collected at Visit 1

[12] history of drug or alcohol abuse/dependence within 1 year prior to Visit 1(excessive or compulsive use as judged by the investigator), or currently using drugs of potential abuse or any prescribed or over-the-counter medication in a

manner that the investigator considers indicative of abuse/dependence

[13] have a positive urine drug screen for any substances of abuse at Visit 1

[14] have an acute, serious or unstable medical condition, or a history or presence of any other medical illness including but not limited to any autoimmune disease,CV, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, or any clinically significant laboratory abnormality, that, in the judgment of the investigator, indicates a medical problem that would preclude study

participation

[15] known hypersensitivity to multiple drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain <br/ ><br>freedom compared to placebo.Timepoint: The proportion of patients in each group that are pain-free <br/ ><br>at 2 hours postdose during the first attack.