AzTrials
AzTrials

MigraineENERGYNCT06968429

Efficacy and Safety of Oral NBP Soft Capsules for the Prevention of Episode Migraine Attacks in Adult Migraine Patients

A study testing NBP Softgel Capsules in people with Migraine, run by Chinese PLA General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

This is a multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of oral butylphthalide soft capsules for the prophylactic treatment of migraine in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
NBP Softgel Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
No sites listed yet
Study dates
May 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients will be excluded from this study if they meet any of the following criteria:
  • Target Disease Exclusion:
  • Migraine with brainstem aura or hemiplegic migraine
  • Headache (migraine or non-migraine) ≥ 15 days per month in any month during the 3 months prior to the screening visit
  • Patients with migraine with medication overuse headache
  • Medical history and co-morbidities:
Show all 39Show fewer
  • History of HIV infection
  • Migraine or head or neck regional interventions/devices (e.g., nerve blocks or transcranial magnetic stimulation) within 2 months prior to enrolment
  • Uncontrolled, unstable or recently diagnosed cardiovascular disease (ischaemic heart disease, coronary vasospasm and cerebral ischaemia). Myocardial infarction, acute coronary syndrome, undergoing percutaneous coronary intervention, cardiac surgery, experiencing a stroke or transient ischaemic attack within 6 months (24 weeks) prior to the screening visit.
  • Uncontrolled hypertension or uncontrolled diabetes mellitus. Subjects with a history of hypertension, hypercholesterolaemia and/or diabetes mellitus but whose current status is stable and controlled and who have been receiving a stable dose of medication for at least 3 months (12 weeks) prior to the Screening Visit may be enrolled in the study.
  • History of gastric or small bowel surgery (including gastric bypass, gastric banding, sleeve gastrectomy, intragastric ballooning, etc.) or a condition that causes malabsorption (e.g., chronic pancreatitis, ulcerative colitis, etc.)
  • History of Gilbert's syndrome or current diagnosis of Gilbert's syndrome or any other active liver or biliary tract disease.
  • Diagnosis of haematological or solid malignancy within 5 years prior to screening. For subjects with a history of localised basal cell carcinoma or squamous cell skin cancer, they will be eligible to participate in this study if they are confirmed to be cancer free prior to the screening visit.
  • Any previous or current unstable medical condition (e.g., congenital heart disease or history of cardiac arrhythmia, known or suspected infection, cancer) that, in the opinion of the investigator, would place the subject at increased risk of a significant adverse event during the course of the trial or interfere with the safety/efficacy assessment.
  • Active chronic pain syndromes (e.g. fibromyalgia, chronic pelvic pain, complex localised pain syndrome).
  • Have other pain syndromes (including trigeminal neuralgia), psychiatric disorders, dementia, or major neurological disorders (other than migraine) that, in the opinion of the investigator, may interfere with study evaluation
  • Current or previous diagnosis of schizophrenia, bipolar disorder or borderline personality disorder
  • Has had a depressive episode within the past 12 months or requires more than 1 standard treatment medication daily to treat their depressive disorder or anxiety disorder. For medications used to treat a depressive disorder or anxiety disorder, the medication must have been maintained at a stable dose for at least 3 months prior to the Screening Visit.
  • History, treatment history, or evidence of alcohol or drug abuse in the 12 months (48 weeks) prior to the Screening Visit, or a history of substance abuse consistent with any of the DSM-5 Significant Substances in the 12 months (48 weeks) prior to the Screening Visit through the end of the double-blind treatment period.
  • Subjects should be excluded if they have a positive screening result for addictive drugs that, in the opinion of the Investigator, is medically significant and would compromise the safety of the subject or the interpretation of the study results. In addition:
  • Cocaine, amphetamines, phencyclidine (PCP), and tetrahydrocannabinol (THC) at detectable levels on the Drug Screen need to be excluded.
  • Subjects who have a positive drug screen for amphetamines and are using a prescription amphetamine drug for one of the approved indications (e.g., Attention Deficit Hyperactivity Disorder [ADHD]) may be enrolled in the study at the discretion of the Investigator. The Investigator's decision must be documented in detail in the subject's source medical record. Stimulant dosage must remain stable from the first 3 months (12 weeks) of the observation period to the end of the double-blind treatment period.
  • BMI ≥ 33.0 kg/m2
  • ECG and laboratory findings:
  • Corrected QT interval > 470 ms at screening (QTc corrected using the Fridericia method)
  • left bundle branch block
  • Right bundle branch block with QRS duration ≥150 ms
  • Intracardiac conduction defect with QRS duration ≥150 ms
  • Serum bilirubin (total bilirubin, direct bilirubin, or indirect bilirubin) > 2 x ULN.
  • AST or ALT > 3 × ULN.
  • Neutrophil count ≤ 1000/μL (or equivalent)
  • Allergies and other factors:
  • History of celery allergy
  • Tendency to bleed
  • Reproductive status:
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception or abstinence to avoid pregnancy throughout the study period and for 60 days after the last dose of study drug.
  • Females who are pregnant or breastfeeding.
  • Females with a positive pregnancy test result at screening or prior to study drug administration.
  • Men of childbearing potential who have an active sex life with a woman of childbearing potential but are unwilling or unable to use one or more acceptable methods of contraception or abstinence to avoid pregnancy with their partner throughout the study period and for 90 days after the last dose of study drug.

About this study

Official title: Efficacy and Safety of Oral NBP Soft Capsules for the Prevention of Episode Migraine Attacks in Adult Migraine Patients: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial

This is a multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of oral butylphthalide soft capsules for the prophylactic treatment of migraine in adults.

Conditions
Migraine
Being tested
NBP Softgel Capsules, Placebo
Keywords
Migraine
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBP Softgel CapsulesDrug

    take orally on an empty stomach；2 capsules 3/day

  • PlaceboDrug

    take orally on an empty stomach；2 capsules 3/day

Study groups in NCT06968429
Study groupRoleWhat they receive
NBPExperimentalNot described
Receives: Drug: NBP Softgel Capsules
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of the average monthly migraine days after treatment

    The changes of migraine days each month compared with the observation period throughout the double-blind treatment period (weeks 1 to 12).

    Measured: Baseline and weeks 12

Secondary outcomes (1)

  1. The change in the frequency of using acute painkillers

    The change in the average monthly days of using any acute headache medication 12 weeks after the first administration of butylphthalide soft capsules relative to the observation period

    Measured: Baseline and weeks 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06968429
Sponsor's protocol ID
S2024-399-02
Other IDs
2023YFC2508703
Acronym
ENERGY
Status last verified
Mar 2025
First submitted
21 Apr 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing NBP Softgel Capsules in people with Migraine, run by Chinese PLA General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of the average monthly migraine days after treatment (time frame: Baseline and weeks 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06968429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in