Health Condition 1: G438- Other migraine
Conditions
Interventions
Intervention1: Lasmiditan
Tablets 50 mg: Orally Once onset of migraine attack (within 4 hrs of attack)for the duration of Within 1 week (7 days) after treating 4 attacks
or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier .
Intervention2: Lasmiditan Tablets 100 mg: Orally Once onset of migraine attack( within 4 hrs of attack)for the duratio
or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier
Control Intervention1: Placebo: Orally Once onset of migraine attack( within 4 hrs of attack)for the duration of Within
or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier
Sponsors
Pure And Cure Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are able and willing to give written informed consent and are at least 18 years of age at time of screening visit with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 (migraine without aura) or 1.2.1 (migraine with aura). 2. History of disabling migraine for at least 1 year. 3. Migraine onset before the age of 50 years. 4. History of 3 â?? 8 migraine attacks per month ( during the past 3 months. 5. MIDAS score >=11. 6. Patients who are able and willing to complete subject dairy to record the details of each migraine attack treated with study drug. 7. Females 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 combined oral contraceptives, implanted/injected contraceptives, intrauterine devices (IUD) or sterile partner until 30 days after the last dose of study medication.
Exclusion criteria
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 (BPPV), Meniereâ??s disease, vestibular migraine, and other vestibular disorders. 4. History of diabetes mellitus HbA1C > 8% with complications (diabetic retinopathy, nephropathy, or neuropathy). 5. History of orthostatic hypotension with syncope. 6. Significant renal or hepatic impairment in the opinion of investigator. 7. History, within past 12 months of chronic migraine or other forms of primary or secondary chronic headache disorders (eg, hemicranias continua, medication overuse headache where headache frequency is >= 15 headache days per month). 8. Patients with use of more than 3 doses per month 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. 10. Female patients who are pregnant or breast-feeding. 11. Women of childbearing potential who test positive for pregnancy based on serum/urine pregnancy test collected at screening visit. 12. History of drug or alcohol abuse/dependence within 1 year prior to screening visit (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 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 judgement of the investigator, indicates a medical problem that would preclude study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate proportion of patients in each group that are headache free at 2 hours post dose during the Migraine attacks.Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate proportion of patients in each group requiring rescue medication for migraine within 24 hours of treatment during the Migraine attacks.Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier);Evaluate proportion of patients in each group that are free of MBS associated with migraine at 2 hours post dose during the Migraine attacks.Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier);Evaluate proportion of patients in each group that are free of symptoms associated with migraine at 2 hours post dose during the Migraine attacks. Symptoms includes: Phonophobia, Photophobia, Nausea and Vomiting.Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier);Evaluate proportion of patients in each group with 24-hour sustained pain freedom during the Migraine attacks. [Sustained pain freedom during the first attack defined as pain-free at 2 and 24 hours with no rescue medication]Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier);Evaluate proportion of patients with pain relief in each group at 2 hours post dose during the Migraine attacks. [Pain relief is defined as moderate or severe headache pain becoming mild or none and mild pain becoming none]Timepoint: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed