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

NCT06968429 | Not Yet Recruiting DMC

• 2 other identifiers: S2024-399-022023YFC2508703
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (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).

  Baseline and weeks 12

Secondary Outcomes (1)

• The change in the frequency of using acute painkillers

  Baseline and weeks 12

Study Arms (2)

NBP

EXPERIMENTAL

Drug: NBP Softgel Capsules

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NBP Softgel Capsules DRUG

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

NBP

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients will be excluded from this study if they meet any of the following criteria:
• 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:
• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Peking University First Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The People's Hospital of Hebei Province: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Guizhou Provincial People's Hospital: collaborator

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared in the website of SESH: https://www.seshglobal.org/, within 6 months after the end of research.