ClinicalTrials.gg
RecruitingNCT07792681Updated Oct 23, 2026

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

A Phase 2/3 interventional study of BR005-036C and BR005-036C in Migraine, With or Without Aura, sponsored by Brise Pharmaceuticals Co., Ltd.. Recruiting at 83 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Brise Pharmaceuticals Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 23, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
2,079
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 78 studies in Migraine Disorders with a site in China — 32 open to participants now, 39 under way, 10 of them phase 3. Migraine Disorders · China.

Planned enrollment
4th of 59
2,079 · median 260
Started
2026
with 7 others
Phase 2/3
Only one
of the 78
Primary completion
2028-06
later than 31 of 38 live
Registered
75th of 78
by date
Lead sponsor
2 of 78
Brise Pharmaceuticals Co., Ltd.

Among the 78 studies in Migraine Disorders with a site in China, this one is the 4th largest by planned enrollment of the 59 interventional ones, is one of 8 that started in 2026, is the only one in phase 2/3, reaches primary completion later than 31 of the 38 other live ones, and was the 75th registered.

By phase

78 studies; the count open now beside each. This study's row is marked.

Phase 323 · 6 open
No phase21 · 12 open
Observational19 · 9 open
Phase 46 · 2 open
Phase 25 · 2 open
Phase 13 · 0 open
Phase 2/3this study1 · 1 open

By the year they started

First in 2007; this study’s year is marked. 8 started in 2026.

Size and results

Median enrollment 260 across the 59 interventional studies, 330 across the 19 observational. Of the 28 that completed or were terminated, 10 (36%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 78 studies in Migraine Disorders with a site in China, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Migraine, With or Without Aura

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female Participants aged 18 years or older.
  2. 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.
  3. Onset age of migraine shall be less than 50 years old.
  4. At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit.
  5. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.
  6. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patient with 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.
  3. 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.
  4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.
  5. Abnormal findings at screening: >450 msec for male subjects; QTcF >470 msec for female subjects.
  6. Patient with uncontrolled hypertension.
  7. History of alcohol or substance abuse within 6 months prior to screening.
  8. Clinically significant laboratory abnormalities at screening: , AST or total >1.5 × (ULN); estimated (eGFR) \<60 mL/min/1.73 m².
  9. Use of CGRP receptor antagonists within 1 month prior to screening or randomization; use of anti-CGRP or anti-CGRP-receptor monoclonal antibodies within 6 months prior to screening or randomization.
  10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,079 participants (estimated)

Study arms

  • Experimental
    BR005-036C Dose 1

    Drug: BR005-036C

  • Experimental
    BR005-036C Dose 2

    Drug: BR005-036C

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBR005-036C

    Dose 1, Oral tablet

  • DrugBR005-036C

    Dose 2, Oral tablet

  • DrugPlacebo

    Placebo tablet to match BR005-036C dose, Oral

06

What researchers measure

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

  5. Percentage of Participants with Pain Relief at 2 hours post-dose

    Time frame: 2 hours post-dose

  6. Number of Participants With Adverse Events (AEs)

    Time frame: On-treatment period was from the administration of study intervention and through the EOT visit, up to 9 days

07

Study locations

2 of 83 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.

Of 12 phase 2/3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's planned 21 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 28, 2026
StartActual
Sep 30, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jul 31, 2028
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
83 sites changed recruiting status (81 now not yet recruiting, 2 now recruiting)
Show 83 sites
  • Baoji Central Hospital · Shanxi, Chinano status→Not yet recruiting
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology · Inner Mongolia, Chinano status→Not yet recruiting
  • Peking Union Medical College Hospital · Beijing, Chinano status→Not yet recruiting
  • Peking University People's Hospital · Beijing, Chinano status→Not yet recruiting
  • Beijing Friendship Hospital, Capital Medical University · Beijing, Chinano status→Not yet recruiting
  • Xuanwu Hospital, Capital Medical University · Beijing, Chinano status→Not yet recruiting
  • Peking University Third Hospital · Beijing, Chinano status→Not yet recruiting
  • First Medical Center of Chinese PLA General Hospital · Beijing, Chinano status→Recruiting
  • The First Affiliated Hospital of Bengbu Medical College · Anhui, Chinano status→Not yet recruiting
  • Cangzhou Central Hospital · Hebei, Chinano status→Not yet recruiting
  • The Second Hospital of Jilin University · Jilin City, Chinano status→Not yet recruiting
  • Changde First People's Hospital · Hunan, Chinano status→Not yet recruiting
  • The Third Hospital of Changsha · Hunan, Chinano status→Not yet recruiting
  • Changsha Central Hospital · Hunan, Chinano status→Not yet recruiting
  • Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
  • The Second Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
  • The Third Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
  • The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center) · Chongqing, Chinano status→Not yet recruiting
  • The First Affiliated Hospital of Chongqing Medical University · Chongqing, Chinano status→Not yet recruiting
  • Chonggang General Hospital · Chongqing, Chinano status→Not yet recruiting
  • Chongqing University Three Gorges Hospital · Chongqing, Chinano status→Not yet recruiting
  • Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology · Liaoning, Chinano status→Not yet recruiting
  • Dazhou Central Hospital · Sichuan, Chinano status→Not yet recruiting
  • Guangdong Provincial People's Hospital · Guangzhou, Chinano status→Not yet recruiting
  • Guangzhou First People's Hospital · Guangdong, Chinano status→Not yet recruiting
  • The Second Affiliated Hospital of Guangzhou Medical University · Guangdong, Chinano status→Not yet recruiting
  • The Second Affiliated Hospital, Zhejiang University School of Medicine · Zhejiang, Chinano status→Not yet recruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine · Zhejiang, Chinano status→Not yet recruiting
  • The Fourth Affiliated Hospital of Harbin Medical University · Heilongjiang, Chinano status→Not yet recruiting
  • The Second People's Hospital of Hefei · Anhui, Chinano status→Not yet recruiting
  • …and 53 more on the registry record
Oct 23, 2026
Start date
Sep 15, 2026→Sep 30, 2026 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    83 sites changed recruiting status (81 now not yet recruiting, 2 now recruiting)
    Show 83 sites
    • Baoji Central Hospital · Shanxi, Chinano status→Not yet recruiting
    • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology · Inner Mongolia, Chinano status→Not yet recruiting
    • Peking Union Medical College Hospital · Beijing, Chinano status→Not yet recruiting
    • Peking University People's Hospital · Beijing, Chinano status→Not yet recruiting
    • Beijing Friendship Hospital, Capital Medical University · Beijing, Chinano status→Not yet recruiting
    • Xuanwu Hospital, Capital Medical University · Beijing, Chinano status→Not yet recruiting
    • Peking University Third Hospital · Beijing, Chinano status→Not yet recruiting
    • First Medical Center of Chinese PLA General Hospital · Beijing, Chinano status→Recruiting
    • The First Affiliated Hospital of Bengbu Medical College · Anhui, Chinano status→Not yet recruiting
    • Cangzhou Central Hospital · Hebei, Chinano status→Not yet recruiting
    • The Second Hospital of Jilin University · Jilin City, Chinano status→Not yet recruiting
    • Changde First People's Hospital · Hunan, Chinano status→Not yet recruiting
    • The Third Hospital of Changsha · Hunan, Chinano status→Not yet recruiting
    • Changsha Central Hospital · Hunan, Chinano status→Not yet recruiting
    • Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
    • The Second Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
    • The Third Xiangya Hospital of Central South University · Hunan, Chinano status→Not yet recruiting
    • The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center) · Chongqing, Chinano status→Not yet recruiting
    • The First Affiliated Hospital of Chongqing Medical University · Chongqing, Chinano status→Not yet recruiting
    • Chonggang General Hospital · Chongqing, Chinano status→Not yet recruiting
    • Chongqing University Three Gorges Hospital · Chongqing, Chinano status→Not yet recruiting
    • Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology · Liaoning, Chinano status→Not yet recruiting
    • Dazhou Central Hospital · Sichuan, Chinano status→Not yet recruiting
    • Guangdong Provincial People's Hospital · Guangzhou, Chinano status→Not yet recruiting
    • Guangzhou First People's Hospital · Guangdong, Chinano status→Not yet recruiting
    • The Second Affiliated Hospital of Guangzhou Medical University · Guangdong, Chinano status→Not yet recruiting
    • The Second Affiliated Hospital, Zhejiang University School of Medicine · Zhejiang, Chinano status→Not yet recruiting
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine · Zhejiang, Chinano status→Not yet recruiting
    • The Fourth Affiliated Hospital of Harbin Medical University · Heilongjiang, Chinano status→Not yet recruiting
    • The Second People's Hospital of Hefei · Anhui, Chinano status→Not yet recruiting
    • …and 53 more on the registry record
    Start date Sep 15, 2026→Sep 30, 2026 (now actual)
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07792681
Lead sponsor
Brise Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Sep 30, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Brise Pharmaceuticals Co., Ltd.
Contact
ra@brisepharma.com
+81-21-80517689

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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