Health TrialsbyHealthPanel

Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults

ConditionMigraine, With or Without Aura
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrise Pharmaceuticals Co., Ltd.

About this trial

The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female Participants aged 18 years or older.

Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year.

Onset age of migraine shall be less than 50 years old.

At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit.

Disqualifiers

Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia.

Patient with clinically significant cardiovascular, cerebrovascular, hematological, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological or psychiatric disorders; patient with other confounding acute or chronic pain syndromes, dementia, epilepsy, or other diseases (other than migraine) that may interfere with study assessments.

Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis.

Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BR005-036C

    Drug

    Dose 1, Oral tablet

  • BR005-036C

    Drug

    Dose 2, Oral tablet

  • Placebo

    Drug

    Placebo tablet to match BR005-036C dose, Oral

Treatment groups

2,079 Participants
are divided into 3 treatment groups
Group A: BR005-036C Dose 1Experimental treatment 1 intervention
Group B: BR005-036C Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Freedom from Pain at 2 hours post-dose

Time frame
2 hours post-dose
2

Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose

Time frame
2 hours post-dose

Secondary outcomes

1

Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose

Time frame
From 2 hours up to 24 hours post-dose
2

Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose

Time frame
From 2 hours up to 48 hours post-dose
3

Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose

Time frame
From 2 hours up to 24 hours post-dose
4

Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose

Time frame
2 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brise Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: