ClinicalTrials.gg
Not yet recruitingNCT07835152Updated Sep 25, 2026

Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults

A Phase 3 interventional study of BR005-036C in Migraine, With or Without Aura, sponsored by Brise Pharmaceuticals Co., Ltd.. Not yet recruiting at 81 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
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
9th of 59
1,000 · median 260
Started
2026
with 7 others
Phase 3
23 of 78
6 open now
Primary completion
2029-03
later than 34 of 38 live
Registered
77th 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 9th largest by planned enrollment of the 59 interventional ones, is one of 8 that started in 2026, is one of 23 in phase 3, reaches primary completion later than 34 of the 38 other live ones, and was the 77th registered.

By phase

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

Phase 3this study23 · 6 open
No phase21 · 12 open
Observational19 · 9 open
Phase 46 · 2 open
Phase 25 · 2 open
Phase 13 · 0 open
Phase 2/31 · 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 evaluate the long-term safety of BR005-036C tablets in the acute treatment of 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. At least 2 migraine attacks need to treat per month within 3 months prior to screening visit.
  4. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.
  5. 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    BR005-036C

    Drug: BR005-036C

Interventions

  • DrugBR005-036C

    Dose 1, Oral tablet, PRN

06

What researchers measure

Primary outcomes

  1. Number of participants with ≥5% AEs,SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Percentage of participants with Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) concurrent with Total Bilirubin > 2 x ULN during the treatment period

    Time frame: Up to 52 weeks

  2. Number of participants with hepatic functional abnormal during the treatment period

    Time frame: Up to 52 weeks

  3. Percentage of participants stratified by satisfaction level after BR005-036C treatment

    Time frame: Up to 52 weeks

07

Study locations

81 sites
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

Start is estimated for Sep 2026; primary completion for Mar 2029, 30 months later.

Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 30 months is above that.

Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.

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

Registered
Sep 17, 2026
First posted
Sep 22, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 31, 2029
CompletionEst.
Apr 30, 2029
Last update
Sep 25, 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.
Minor edits
Nothing that changes what the study is or who can join. Edited: arm descriptions
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: arm descriptions

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
NCT07835152
Lead sponsor
Brise Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 31, 2029 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

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

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion