Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks

NCT04948164 | Unknown Phase 3 DMC

• 1 other identifier: D2018061
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sumatriptan naproxen sodium succinate tablets in the treatment of acute migraine attacks.

Conditions

Migraine in Adults

Outcome Measures

Primary Outcomes (1)

• Relief rate

  Complete headache relief rate within 2 hours after taking the drug for the first time (proportion of subjects without headache)

  2hr after taking the drug

Study Arms (2)

Test group

EXPERIMENTAL

Drug: sumatriptan 85mg and naproxen sodium 500mg

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

sumatriptan 85mg and naproxen sodium 500mg DRUG

Subjects took 1 tablet of the study drug (each containing sumatriptan 85mg and naproxen sodium 500mg) within 1h of an acute migraine attack of mild severity, and if the headache progressed to moderate severity within 2 hours, they could take the remedial drug phenol chai (each containing acetaminophen 500mg and caffeine 65mg).

Test group

Placebo DRUG

subjects were given one tablet of placebo within 1 h of an acute migraine attack with mild severity, and if the headache progressed to moderate severity within 2 hours, they were given the remedial drug phenol chai (each tablet contains acetaminophen 500 mg and caffeine 65 mg)."

Control group

Eligibility Criteria

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

You may qualify if:

• \. Age ≥18 years old and \<65 years old at the time of signing the informed consent form, regardless of gender;
• \. Diagnose patients who meet the criteria for the diagnosis of migraine without aura in the third trial version of the International Classification of Headache Diseases (ICHD-Ⅲ(β)) launched by the International Headache Association, and the degree is moderate or severe;
• \. The age of the patient's first migraine attack should be less than 50 years old, and must meet 5 or more migraine attacks without aura or a history of migraine without aura ≥ 1 year;
• \. The number of moderate or severe migraine attacks ≤6 and ≥1 per month within the first 3 months of enrollment, and at least a 48-hour headache interval;
• \. Ability to distinguish migraine patients from other types of headaches during headache attacks;
• \. Female patients who have not had unprotected sex in the 15 days before screening, and patients (regardless of men and women) who have no childbirth plans during the trial period and within 6 months after the end of the trial;
• \. Patients who have the ability to cooperate in observing curative effects and adverse events, and record headache diaries;
• \. Before starting any detailed procedures of this study, the patient has the ability to understand and sign a written informed consent form approved by the ethics committee

You may not qualify if:

• \. Patients with migraine with aura, including but not limited to patients with brainstem migraine with aura and patients with hemiplegic migraine;
• \. Patients with average headache time ≥15 days per month in the 3 months before the test;
• \. Patients who have taken painkillers for a long time or overuse of painkillers (take painkillers for more than 10 days a month for 3 consecutive months);
• \. Abnormal renal function: creatinine value\> upper limit of normal value;
• \. Patients with a history of severe liver disease or patients with significantly abnormal liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal or total bilirubin (TBIL) )≥1.5 times the upper limit of the normal value;
• \. History of major mental and neurological diseases such as depression and epilepsy;
• \. Patients who have taken central sedatives for a long time, such as barbiturates and benzodiazepines, including diazepam, lorazepam, etc.;
• \. Patients with severe cardiovascular diseases, such as coronary artery bypass surgery, or patients with a history of one of the following diseases, including but not limited to ischemic heart disease, such as angina (including Platts variant angina), Patients with a history of myocardial infarction, arrhythmia (such as pre-excitation syndrome) or disease-related symptoms, signs, or a significant ECG abnormal change;
• \. Patients with severe cerebrovascular diseases, including but not limited to cerebral ischemia, cerebral hemorrhage diseases;
• \. With severe peripheral vascular disease, such as Raynaud's syndrome;
• \. Patients whose blood pressure cannot be effectively controlled after drug treatment, systolic blood pressure (SBP)\>140mmHg or diastolic blood pressure (DBP)\>90mmHg;
• \. Take ergotamine or ergot derivatives (such as dihydroergotamine or ergonovine) or other 5-HT1 receptor agonists within 7 days before randomization;
• \. Patients who have taken MAOI within 14 days before screening;
• \. Patients who cannot stop using anticoagulant drugs (such as warfarin) or antiplatelet drugs (such as aspirin) during the trial;
• \. Patients who have previously undergone gastric resection or bypass surgery, or patients with a history of gastrointestinal bleeding, ulcers, or perforation;

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Jiangsu Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Second Hospital of Jilin University: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Beijing Friendship Hospital: collaborator
• West China Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Sumatriptan; Naproxen

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Yingshuang Zhang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingshuang Zhang

CONTACT

18511650863; zhangys0317@126.com

Xiaoxuan Liu

CONTACT

13910982101

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 1, 2021
• Study Start: August 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)