CTRI/2023/01/048905尚未招募3 期
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. - None
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ( < 15 headache days 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.
排除标准
- •1. Known hypersensitivity to lasmiditan, or to any excipient of Lasmiditan oral
- •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.
研究者
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