CTRI/2023/01/048905Not yet recruitingPhase 3
A Phase III, Multi-centre, Randomised, Double-Blind, Parallel-Group, Placebo-controlled Trial to evaluate the Efficacy, Safety and Tolerability of Lasmiditan Tablets 50 mg/100 mg compared to Placebo in Adult Patients for the Acute Treatment of Migraine with or Without Aura.
Pure And Cure Healthcare Private Limited12 sites in 1 country246 target enrollmentStarted: January 16, 2023Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 246
- Locations
- 12
- Primary Endpoint
- Evaluate proportion of patients in each group that are headache free at 2 hours
Study Overview
Brief Summary
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be done during screening visit and baseline visit. Physical examination shall be done during each successive visit. MIDAS questionnaire assessments and BMI will be performed at screening visit.
Eligible subjects will be enrolled to receive treatment with investigational products orally once for the migraine attacks during the study period.
Subjects will be asked to treat their migraine attack within 4 hours of onset providing that the headache severity is at least moderate (moderate pain is applicable only for first attack) at that time and not improving.
Subjects will be asked not to use rescue medication until at least 2 hours after dosing with study drug and completing the 2-hour assessments. If the migraine does not respond at 2 hours (headache becomes pain free), patients will be allowed to take rescue medication. The efficacy and safety analysis will be conducted in Modified Intention to treat population.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
- •History of disabling migraine for at least 1 year.
- •Migraine onset before the age of 50 years.
- •History of 3 – 8 migraine attacks per month (< 15 headache days per month) during the past 3 months.
- •MIDAS score ≥
- •Patients who are able and willing to complete subject dairy to record the details of each migraine attack treated with study drug.
- •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
- •Known hypersensitivity to lasmiditan, or to any excipient of Lasmiditan oral tablets.
- •History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the patient 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 HbA1C > 8% with complications (diabetic retinopathy, nephropathy, or neuropathy).
- •History of orthostatic hypotension with syncope.
- •Significant renal or hepatic impairment in the opinion of investigator.
- •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).
- •Patients with use of more than 3 doses per month either opioids or barbiturates.
- •Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening visit.
- •Female patients who are pregnant or breast-feeding.
- •Women of childbearing potential who test positive for pregnancy based on serum/urine pregnancy test collected at screening visit.
- •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.
- •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.
Outcomes
Primary Outcomes
Evaluate proportion of patients in each group that are headache free at 2 hours
Time Frame: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier)
post dose during the Migraine attacks.
Time Frame: Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier)
Secondary Outcomes
- Evaluate proportion of patients in each group that are free of MBS associated(with migraine at 2 hours post dose during the Migraine attacks.)
- Evaluate proportion of patients with pain relief in each group at 2 hours post(dose during the Migraine attacks.)
- Evaluate proportion of patients in each group with 24-hour sustained pain(freedom during the Migraine attacks.)
- Evaluate proportion of patients in each group requiring rescue medication for(migraine within 24 hours of treatment during the Migraine attacks.)
- Evaluate proportion of patients in each group that are free of symptoms(associated with migraine at 2 hours post dose during the Migraine attacks.)
Investigators
Study Sites (12)
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