Migraine in AdultsPhase 3NCT04948164
Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks
A Phase 3 study testing sumatriptan 85mg and naproxen sodium 500mg in people with Migraine in Adults, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine in Adults
- What is being tested?
- sumatriptan 85mg and naproxen sodium 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old and <65 years old at the time of signing the informed consent form, regardless of gender;
- 2. 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;
- 3. 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;
- 4. 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;
- 5. Ability to distinguish migraine patients from other types of headaches during headache attacks;
- 6. 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;
- 7. Patients who have the ability to cooperate in observing curative effects and adverse events, and record headache diaries;
- 8. 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
Who cannot join
- 1. Patients with migraine with aura, including but not limited to patients with brainstem migraine with aura and patients with hemiplegic migraine;
- 2. Patients with average headache time ≥15 days per month in the 3 months before the test;
- 3. 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);
- 4. Abnormal renal function: creatinine value> upper limit of normal value;
- 5. 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;
- 6. History of major mental and neurological diseases such as depression and epilepsy;
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- 7. Patients who have taken central sedatives for a long time, such as barbiturates and benzodiazepines, including diazepam, lorazepam, etc.;
- 8. 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;
- 9. Patients with severe cerebrovascular diseases, including but not limited to cerebral ischemia, cerebral hemorrhage diseases;
- 10. With severe peripheral vascular disease, such as Raynaud's syndrome;
- 11. Patients whose blood pressure cannot be effectively controlled after drug treatment, systolic blood pressure (SBP)>140mmHg or diastolic blood pressure (DBP)>90mmHg;
- 12. Take ergotamine or ergot derivatives (such as dihydroergotamine or ergonovine) or other 5-HT1 receptor agonists within 7 days before randomization;
- 13. Patients who have taken MAOI within 14 days before screening;
- 14. Patients who cannot stop using anticoagulant drugs (such as warfarin) or antiplatelet drugs (such as aspirin) during the trial;
- 15. Patients who have previously undergone gastric resection or bypass surgery, or patients with a history of gastrointestinal bleeding, ulcers, or perforation;
- 16. Patients suffering from sinusitis;
- 17. Regularly take drugs for preventing headache attacks for more than 2 weeks before randomization, including but not limited to flunarizine, topiramate and Chinese patent medicines with similar effects;
- 18. Known to triptan drugs, NSAIDs or their pharmaceutical excipients Patients with allergies, or have had aspirin asthma or aspirin triad (aspirin allergy, asthma, and nasal polyps);
- 19. For patients with alcohol abuse and drug abuse, the standard for alcohol abuse is: drinking an average of more than 28 units per week (a unit of alcohol is equivalent to 250 mL of beer, 125 mL of wine or 20 mL of spirits or enthusiastic alcoholism); There are two types of drugs: one is narcotic drugs, such as heroin, marijuana and cannabis resin, opiates and morphine preparations, codeine, etc.; the other is psychotropic drugs, such as various hallucinogens and tetrahydrocannabinol, central stimulants Drugs, barbiturates, benzodiazepines, etc.;
- 20. Patients who are pregnant, breastfeeding, or have a childbearing plan during the study period, including female patients of childbearing age who have a positive pregnancy test;
- 21. Patients who have participated in any other clinical trials within 3 months before participating in this trial, and who plan to participate in other clinical trials of other drugs;
- 22. The patient may not be able to complete the trial due to reasons, or the investigator believes that the patient is not suitable to participate in this trial. "
Trial locations and contacts
1 site in 1 country.
Xiaoxuan Liu contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Yingshuang Zhang, 18511650863
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks.
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.
Read the detailed description
Migraine is a common chronic nerve vascular disease, the disease characteristic to break out repeatedly, one side or both sides of the pulsatile partial side head, severe headache and can combine autonomic nervous system dysfunction such as nausea, vomiting, photophobia, and fear the symptom such as, about one-third of patients with migraine aura symptoms can appear before the onset of the nervous system. Sulaptan is a 5-HT1 receptor agonist with a high affinity for binding to 5-HT1b and 5-HT1D receptors. Naproxen is an NSAID that inhibs the synthesis of inflammatory mediators. Thus, sulaptan and naproxen alleviate migraine through different pharmacological mechanisms of action. For this test center, randomized, double-blind, placebo-controlled, parallel-group Ⅲ phase of clinical trial, aimed to verify shu Ma Putan naproxen sodium treatment of acute migraine headache, headache complete remission rate after 2 hours, evaluation of succinic acid shu Ma Putan naproxen sodium tablets for efficacy and safety of the treatment of acute migraine attacks.
- Conditions
- Migraine in Adults
- Being tested
- sumatriptan 85mg and naproxen sodium 500mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan 85mg and naproxen sodium 500mgDrug
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).
PlaceboDrug
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)."
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: sumatriptan 85mg and naproxen sodium 500mg |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief rate
Complete headache relief rate within 2 hours after taking the drug for the first time (proportion of subjects without headache)
Measured: 2hr after taking the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Aug 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in AdultsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Second Hospital of Jilin University, The Second Affiliated Hospital of Kunming Medical University, The Second Hospital of Nanjing Medical University, The Affiliated Hospital of Qingdao University, Beijing Friendship Hospital, West China Hospital, Second Affiliated Hospital of Wenzhou Medical University, The Third Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Yingshuang Zhang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948164
- Sponsor's protocol ID
- D2018061
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks.
- ClinicalTrials.gov ID
- NCT04948164
- Acronym / sponsor ID
- D2018061
- Conditions
- Migraine in Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Second Hospital of Jilin University, The Second Affiliated Hospital of Kunming Medical University, The Second Hospital of Nanjing Medical University, The Affiliated Hospital of Qingdao University, Beijing Friendship Hospital, West China Hospital, Second Affiliated Hospital of Wenzhou Medical University, The Third Xiangya Hospital of Central South University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Migraine is a common chronic nerve vascular disease, the disease characteristic to break out repeatedly, one side or both sides of the pulsatile partial side head, severe headache and can combine autonomic nervous system dysfunction such as nausea, vomiting, photophobia, and fear the symptom such as, about one-third of patients with migraine aura symptoms can appear before the onset of the nervous system. Sulaptan is a 5-HT1 receptor agonist with a high affinity for binding to 5-HT1b and 5-HT1D receptors. Naproxen is an NSAID that inhibs the synthesis of inflammatory mediators. Thus, sulaptan and naproxen alleviate migraine through different pharmacological mechanisms of action. For this test center, randomized, double-blind, placebo-controlled, parallel-group Ⅲ phase of clinical trial, aimed to verify shu Ma Putan naproxen sodium treatment of acute migraine headache, headache complete remission rate after 2 hours, evaluation of succinic acid shu Ma Putan naproxen sodium tablets for efficacy and safety of the treatment of acute migraine attacks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: sumatriptan 85mg and naproxen sodium 500mg |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Age ≥18 years old and <65 years old at the time of signing the informed consent form, regardless of gender;
- 2. 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;
- 3. 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;
- 4. 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;
- 5. Ability to distinguish migraine patients from other types of headaches during headache attacks;
Key exclusion criteria (22 listed)
- 1. Patients with migraine with aura, including but not limited to patients with brainstem migraine with aura and patients with hemiplegic migraine;
- 2. Patients with average headache time ≥15 days per month in the 3 months before the test;
- 3. 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);
- 4. Abnormal renal function: creatinine value> upper limit of normal value;
- 5. 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sumatriptan 85mg and naproxen sodium 500mgSubjects 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). | Drug | Test group |
| Placebosubjects 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)." | Drug | Control group |
Primary outcome
Relief rate
Time frame: 2hr after taking the drug
Complete headache relief rate within 2 hours after taking the drug for the first time (proportion of subjects without headache)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoxuan Liu contact
Yingshuang Zhang principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sumatriptan 85mg and naproxen sodium 500mg in people with Migraine in Adults, run by Peking University Third Hospital at 1 site in China.
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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingshuang Zhang (18511650863, zhangys0317@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief rate (time frame: 2hr after taking the drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2021.