TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
NCT ID: NCT05484349
Last Updated: 2024-08-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
189 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-01
Study Completion Date
2025-12-25
Brief Summary
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In this study,189 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults.
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Detailed Description
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1. Research contents:
In this study,189 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults.
2. Research target:
To evaluate the efficacy, safety and tolerability of oral Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults, we used the change from baseline in migraine days per 4 weeks during the 12-week treatment period as the primary endpoint.
3. Research design:
This study uses a multicenter, randomized, double blind, placebo controlled, parallel design and plans to enroll 189 adult patients with episodic migraine.
4. A total of 189 patients were planned to be enrolled, and all subjects were randomly assigned to group A (Tizanidine Hydrochloride 1 mg Tid) , group B (Tizanidine Hydrochloride 2 mg Tid) and group C (placebo 1 tablet Tid) according to a 1:1 :1ratio, with 63 subjects in each group. All Tizanidine Hydrochloride and placebo were produced and supplied by Sichuan Credit Pharmaceutical Co. Ltd.
The enrolled subjects were orally administered Tizanidine Hydrochlorid and placebo for 12 consecutive weeks of treatment, and followed up for 12 weeks. That means doing face-to-face visits at the 4th, 8th, 12th and 16th weeks after dosing .
This study is divided into 3 phases: screening/baseline period (4 weeks, D-28\~D-1), double-blind treatment period (12 weeks, D1\~D84), follow-up period (4 weeks, D85-D112), a total of About 20 weeks.
5. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. Good Clinical Practice(GCP) training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial.
6. Statistical analysis plan： Efficacy evaluation: The primary endpoint was analyzed by Mixed Model for Repeated Measures(MMRM).And the primary endpoint analysis was based on the analysis results of Full Analysis Set(FAS) and Per Protocol Set(PPS).
In this study,189 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults.
2. Research target:
To evaluate the efficacy, safety and tolerability of oral Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults, we used the change from baseline in migraine days per 4 weeks during the 12-week treatment period as the primary endpoint.
3. Research design:
This study uses a multicenter, randomized, double blind, placebo controlled, parallel design and plans to enroll 189 adult patients with episodic migraine.
4. A total of 189 patients were planned to be enrolled, and all subjects were randomly assigned to group A (Tizanidine Hydrochloride 1 mg Tid) , group B (Tizanidine Hydrochloride 2 mg Tid) and group C (placebo 1 tablet Tid) according to a 1:1 :1ratio, with 63 subjects in each group. All Tizanidine Hydrochloride and placebo were produced and supplied by Sichuan Credit Pharmaceutical Co. Ltd.
The enrolled subjects were orally administered Tizanidine Hydrochlorid and placebo for 12 consecutive weeks of treatment, and followed up for 12 weeks. That means doing face-to-face visits at the 4th, 8th, 12th and 16th weeks after dosing .
This study is divided into 3 phases: screening/baseline period (4 weeks, D-28\~D-1), double-blind treatment period (12 weeks, D1\~D84), follow-up period (4 weeks, D85-D112), a total of About 20 weeks.
5. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. Good Clinical Practice(GCP) training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial.
6. Statistical analysis plan： Efficacy evaluation: The primary endpoint was analyzed by Mixed Model for Repeated Measures(MMRM).And the primary endpoint analysis was based on the analysis results of Full Analysis Set(FAS) and Per Protocol Set(PPS).
Conditions
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Migraine Without Aura
Migraine With Aura
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A total of 189 patients were planned to be enrolled, and all subjects were randomly assigned to group A (Tizanidine Hydrochloride 1 mg Tid) , group B (Tizanidine Hydrochloride 2 mg Tid) and group C (placebo 1 tablet Tid) according to a 1:1 :1ratio, with 63 subjects in each group.
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
In this double blind clinical trial, Tizanidine Hydrochloride was identical in appearance to the Tizanidine Hydrochloride placebo. Patients, investigators (persons who screen patients, assess endpoints, and assess protocol compliance), and sponsor personnel associated with clinical research should be blinded.
Study Groups
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group A
Tizanidine Hydrochloride 1 mg Tid
Group Type
EXPERIMENTAL
Tizanidine Hydrochloride
Intervention Type
DRUG
Tizanidine Hydrochloride 1 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
group B
Tizanidine Hydrochloride 2 mg Tid
Group Type
EXPERIMENTAL
Tizanidine Hydrochloride
Intervention Type
DRUG
Tizanidine Hydrochloride 2 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
group C
placebo 1 tablet Tid
Group Type
PLACEBO_COMPARATOR
Tizanidine Hydrochloride Placebo
Intervention Type
DRUG
Tizanidine Hydrochloride Placebo Comparator 1 tablet Tid for 12 consecutive weeks and were followed up for 12 weeks
Interventions
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Tizanidine Hydrochloride
Tizanidine Hydrochloride 1 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
Intervention Type
DRUG
Tizanidine Hydrochloride
Tizanidine Hydrochloride 2 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
Intervention Type
DRUG
Tizanidine Hydrochloride Placebo
Tizanidine Hydrochloride Placebo Comparator 1 tablet Tid for 12 consecutive weeks and were followed up for 12 weeks
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. The age at entry for trails involving adult subjects is 18-65 years (including both ends)；
2. According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine without aura and/or migraine with aura, and should have a history of at least 1 year;
3. The age at first migraine onset should be \<50 years;
4. Migraine attacks ≥ 4 days/month and \< 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
5. Within 3 months before entering the screening period, the number of headache (including migraine and other types of headache) attack days per month is less than 15 days/month (Refer to the definition of headache days);
6. Be willing to take effective contraceptive measures during the period of participating in this experiment and within 28 days after the last time taking investigational product;
7. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the baseline period.
The following criteria must be met during the baseline period to be eligible for entering the randomized, double-blind, placebo-controlled trial of the drug:
8. Migraine days ≥4 and \<14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);
9. Headache days \< 14 days within 4 weeks of baseline period;
10. Completion of at least 80% of the electronic diary within 4 weeks of the baseline period(Within 28 days of the baseline period, the electronic diary has been completed for at least 23 days), and the investigator believes that the subject is able to read, understand, and complete the study questionnaire and headache diary;
11. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the randomized, double-blind, placebo-controlled trials of the drug.
2. According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine without aura and/or migraine with aura, and should have a history of at least 1 year;
3. The age at first migraine onset should be \<50 years;
4. Migraine attacks ≥ 4 days/month and \< 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
5. Within 3 months before entering the screening period, the number of headache (including migraine and other types of headache) attack days per month is less than 15 days/month (Refer to the definition of headache days);
6. Be willing to take effective contraceptive measures during the period of participating in this experiment and within 28 days after the last time taking investigational product;
7. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the baseline period.
The following criteria must be met during the baseline period to be eligible for entering the randomized, double-blind, placebo-controlled trial of the drug:
8. Migraine days ≥4 and \<14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);
9. Headache days \< 14 days within 4 weeks of baseline period;
10. Completion of at least 80% of the electronic diary within 4 weeks of the baseline period(Within 28 days of the baseline period, the electronic diary has been completed for at least 23 days), and the investigator believes that the subject is able to read, understand, and complete the study questionnaire and headache diary;
11. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the randomized, double-blind, placebo-controlled trials of the drug.
Exclusion Criteria
Subjects with any of the following cannot participate in this study:
1. Subject diagnosed with possible migraine according to ICHD-3(2018);
2. Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are defined according to ICHD-3,2018);
3. Previous use of more than two of the following 7 drugs is ineffective after adequate use, the types of these drugs are as follows:
* Type 1: Divalproex, Sodium Valproate
* Type 2: Topiramate
* Type 3: Beta blockers(such as: Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebivolol, Pindolol, Propranolol, Timolol)
* Type 4: Tricyclic antidepressants(TCA) (such as: Amitriptyline, Nortriptyline, Protriptyline)
* Type 5: Serotonin-norepinephrine reuptake inhibitors (SNRIs) (such as: Venlafaxine, Desvenlafaxine, Duloxetine, Milnacipran)
* Type 6: Flunarizine, Verapamil
* Type 7: lisinopril, Candesartan
* Type 8: Drugs acting on the CGRP pathway（Monoclonal antibodies and Gepants）
Definition of treatment failure: No reduction in headache frequency, duration, or severity after 6 weeks of administration of the above drugs.
The following conditions are not defined as treatment failure:
* Lack of sustained response to medication;
* Can not be tolerated dose of drug
4. Use of prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or therapies, etc. 2 months before the baseline period or during the baseline period (more details are in Prohibited Drugs/Treatments);
5. Subjects who intend to undergo head, face or neck injections of therapeutic or cosmetic Botulinum Toxin(such as Dysport, Botox, Xeomin, Myobloc and JeuvwauTM) during the study period or within 4 months before screening;
6. Simultaneous use of two or more drugs that may have migraine preventive effects within 2 months before the start of the baseline period or during the baseline period (more details are in Annex- The List of Migraine Preventive Medications ) (If only one prophylactic drug is used, the dose must be stable for the two months prior to the baseline period and throughout the study);
7. The following occurred within two months prior to the start of the baseline period:
* Taking Ergotamines or Triptans for ≥10 days per month, or
* Taking NSAIDs alone for ≥15 days compound or preparation of NSAIDs≥10 days, or
* Taking Opioid or Barbiturate analgesics for ≥4 days per month
8. Fluvoxamine, ciprofloxacin (cytochrome oxidase P450IA2 inhibitor), fluoroquinolones, zileuton, antiarrhythmics (amiodarone, mexiletine, propafenone, and verapamil) , cimetidine, famotidine, acyclovir, ticlopidine, metoprolol, propranolol and other beta-blockers, clonidine and other alpha2-adrenergic agonists , Chinese patent medicine, Chinese herbal medicine, instrument or program (see 5.7.2 Prohibited Drugs/Treatment for details)
9. Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);
10. Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；Subjects PHQ-9 score\<15 are allowed to enter the double-blind treatment period if they had a history of anxiety or depression and were taking no more than one psychotropic drug (excluding contraindicated drugs) (Subjects must have taken a stable therapeutic dose within 3 months prior to the baseline period);
11. Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);
12. Patients with a history of malignant tumour within five years prior to the screening period, excluding non-melanoma skin cancer, cervical or breast ductal carcinoma in situ;
13. The screening period meets any of the following laboratory values:
* Alanine transaminase (ALT) or aspartate aminotransferase (AST) \>1.5×（upper limit of normal, ULN）, or
* Total bilirubin(TBIL) \>1.5×ULN （Subjects with diagnosed Gilbert syndrome excluded）,or
* The creatinine clearance rate is less than 25 mg/min, and the creatinine clearance rate decreases by 50%;
14. Previous heart disease, heart failure, bradycardia, orthostatic hypotension and other types of hypotension, stroke, transient ischemic attack (TIA);
15. The subject has factors that the investigator believes may put the subject at significant risk or may confound the results of the study; The subject has any medical or other reasons for being unfit to participate in the study;
16. According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;
17. Within 12 months before the screening period, according to the subject's medical records or the subject's self-reported history of drug or alcohol abuse;
18. Subjects expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;
19. During the study period, female subjects of childbearing potential were reluctant to use an acceptable method of effective contraception; Infertile women are defined as follows:
* Have a history of menopause, defined as: Age: ≥55 years old, Menopause ≥12 months, or Age:\<55 years old, no spontaneous menstruation for at least 2 years，or Age:\<55 years old, have spontaneous menstruation in the past 1 year, but current is amenorrhea (spontaneous or secondary to hysterectomy), and abnormal postmenopausal Gonadotropin levels: luteinizing hormone(LH), follicle-stimulating hormone(FSH)\>40IU/L or postmenopausal estradiol level \<5ng/dL, or
* Have a history of bilateral oophorectomy, or
* Have a history of hysterectomy, or
* Have a history of bilateral salpingectomy
20. Subjects who participated in other clinical trials within 3 months before the screening period;
21. .Subjects who are allergic to tizanidine hydrochloride or tizanidine hydrochloride excipients;
22. Subjects who cannot maintain their original diet and living habits during the trial;
23. Subjects who intend to take estrogen and/or progesterone drugs during the screening period or after enrollment;
24. Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).
1. Subject diagnosed with possible migraine according to ICHD-3(2018);
2. Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are defined according to ICHD-3,2018);
3. Previous use of more than two of the following 7 drugs is ineffective after adequate use, the types of these drugs are as follows:
* Type 1: Divalproex, Sodium Valproate
* Type 2: Topiramate
* Type 3: Beta blockers(such as: Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebivolol, Pindolol, Propranolol, Timolol)
* Type 4: Tricyclic antidepressants(TCA) (such as: Amitriptyline, Nortriptyline, Protriptyline)
* Type 5: Serotonin-norepinephrine reuptake inhibitors (SNRIs) (such as: Venlafaxine, Desvenlafaxine, Duloxetine, Milnacipran)
* Type 6: Flunarizine, Verapamil
* Type 7: lisinopril, Candesartan
* Type 8: Drugs acting on the CGRP pathway（Monoclonal antibodies and Gepants）
Definition of treatment failure: No reduction in headache frequency, duration, or severity after 6 weeks of administration of the above drugs.
The following conditions are not defined as treatment failure:
* Lack of sustained response to medication;
* Can not be tolerated dose of drug
4. Use of prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or therapies, etc. 2 months before the baseline period or during the baseline period (more details are in Prohibited Drugs/Treatments);
5. Subjects who intend to undergo head, face or neck injections of therapeutic or cosmetic Botulinum Toxin(such as Dysport, Botox, Xeomin, Myobloc and JeuvwauTM) during the study period or within 4 months before screening;
6. Simultaneous use of two or more drugs that may have migraine preventive effects within 2 months before the start of the baseline period or during the baseline period (more details are in Annex- The List of Migraine Preventive Medications ) (If only one prophylactic drug is used, the dose must be stable for the two months prior to the baseline period and throughout the study);
7. The following occurred within two months prior to the start of the baseline period:
* Taking Ergotamines or Triptans for ≥10 days per month, or
* Taking NSAIDs alone for ≥15 days compound or preparation of NSAIDs≥10 days, or
* Taking Opioid or Barbiturate analgesics for ≥4 days per month
8. Fluvoxamine, ciprofloxacin (cytochrome oxidase P450IA2 inhibitor), fluoroquinolones, zileuton, antiarrhythmics (amiodarone, mexiletine, propafenone, and verapamil) , cimetidine, famotidine, acyclovir, ticlopidine, metoprolol, propranolol and other beta-blockers, clonidine and other alpha2-adrenergic agonists , Chinese patent medicine, Chinese herbal medicine, instrument or program (see 5.7.2 Prohibited Drugs/Treatment for details)
9. Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);
10. Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；Subjects PHQ-9 score\<15 are allowed to enter the double-blind treatment period if they had a history of anxiety or depression and were taking no more than one psychotropic drug (excluding contraindicated drugs) (Subjects must have taken a stable therapeutic dose within 3 months prior to the baseline period);
11. Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);
12. Patients with a history of malignant tumour within five years prior to the screening period, excluding non-melanoma skin cancer, cervical or breast ductal carcinoma in situ;
13. The screening period meets any of the following laboratory values:
* Alanine transaminase (ALT) or aspartate aminotransferase (AST) \>1.5×（upper limit of normal, ULN）, or
* Total bilirubin(TBIL) \>1.5×ULN （Subjects with diagnosed Gilbert syndrome excluded）,or
* The creatinine clearance rate is less than 25 mg/min, and the creatinine clearance rate decreases by 50%;
14. Previous heart disease, heart failure, bradycardia, orthostatic hypotension and other types of hypotension, stroke, transient ischemic attack (TIA);
15. The subject has factors that the investigator believes may put the subject at significant risk or may confound the results of the study; The subject has any medical or other reasons for being unfit to participate in the study;
16. According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;
17. Within 12 months before the screening period, according to the subject's medical records or the subject's self-reported history of drug or alcohol abuse;
18. Subjects expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;
19. During the study period, female subjects of childbearing potential were reluctant to use an acceptable method of effective contraception; Infertile women are defined as follows:
* Have a history of menopause, defined as: Age: ≥55 years old, Menopause ≥12 months, or Age:\<55 years old, no spontaneous menstruation for at least 2 years，or Age:\<55 years old, have spontaneous menstruation in the past 1 year, but current is amenorrhea (spontaneous or secondary to hysterectomy), and abnormal postmenopausal Gonadotropin levels: luteinizing hormone(LH), follicle-stimulating hormone(FSH)\>40IU/L or postmenopausal estradiol level \<5ng/dL, or
* Have a history of bilateral oophorectomy, or
* Have a history of hysterectomy, or
* Have a history of bilateral salpingectomy
20. Subjects who participated in other clinical trials within 3 months before the screening period;
21. .Subjects who are allergic to tizanidine hydrochloride or tizanidine hydrochloride excipients;
22. Subjects who cannot maintain their original diet and living habits during the trial;
23. Subjects who intend to take estrogen and/or progesterone drugs during the screening period or after enrollment;
24. Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sichuan Credit Pharmaceutical Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Sponsor Role
lead
Responsible Party
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Kaiming Liu
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kaiming Liu, MD & PHD
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Site Status
NOT_YET_RECRUITING
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
RECRUITING
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
RECRUITING
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Site Status
NOT_YET_RECRUITING
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Site Status
RECRUITING
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, China
Site Status
ACTIVE_NOT_RECRUITING
Countries
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China
Central Contacts
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References
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Lai J, Dilli E. Migraine Aura: Updates in Pathophysiology and Management. Curr Neurol Neurosci Rep. 2020 May 19;20(6):17. doi: 10.1007/s11910-020-01037-3.
Reference Type
RESULT
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
Reference Type
RESULT
GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
Reference Type
RESULT
GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
Reference Type
RESULT
Yu S, Liu R, Zhao G, Yang X, Qiao X, Feng J, Fang Y, Cao X, He M, Steiner T. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012 Apr;52(4):582-91. doi: 10.1111/j.1526-4610.2011.02061.x.
Reference Type
RESULT
Liu R, Yu S, He M, Zhao G, Yang X, Qiao X, Feng J, Fang Y, Cao X, Steiner TJ. Health-care utilization for primary headache disorders in China: a population-based door-to-door survey. J Headache Pain. 2013 Jun 3;14(1):47. doi: 10.1186/1129-2377-14-47.
Reference Type
RESULT
International Headache Congress (IHC), Dublin, Ireland; September 5th-8th, 2019.
Reference Type
RESULT
Luo N, Qi W, Zhuang C, Di W, Lu Y, Huang Z, Sun Y, Zhang A, Huang X, Tao Y, Zhu Y, Li A, Jiang Z, Massing MW, Fang Y. A satisfaction survey of current medicines used for migraine therapy in China: is Chinese patent medicine effective compared with Western medicine for the acute treatment of migraine? Pain Med. 2014 Feb;15(2):320-8. doi: 10.1111/pme.12277. Epub 2013 Nov 8.
Reference Type
RESULT
Other Identifiers
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2022-0622
Identifier Type: -
Identifier Source: org_study_id
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PHASE3
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
NCT00443209
COMPLETED
PHASE3
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
NCT00109083
COMPLETED
PHASE2
Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
NCT05399485
COMPLETED
PHASE3
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
NCT05452239
COMPLETED
PHASE4
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
NCT02423408
COMPLETED
PHASE2
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
NCT05217628
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
NCT02638103
COMPLETED
PHASE3
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
NCT01952574
COMPLETED
PHASE2
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
NCT04355117
COMPLETED
PHASE3
Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine
NCT02629861
COMPLETED
PHASE3
Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
NCT02621931
COMPLETED
PHASE3
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
NCT05989048
COMPLETED
PHASE3
Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients
NCT05411978
UNKNOWN
PHASE4
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
NCT02066415
COMPLETED
PHASE2
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months
NCT00806546
COMPLETED
PHASE3
A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
NCT00055484
COMPLETED
PHASE2
Transcutaneous Pulsed Radiofrequency in Migraine
NCT05499689
UNKNOWN
NA
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
NCT04921384
COMPLETED
PHASE3
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
NCT02745392
COMPLETED
PHASE2/PHASE3
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine
NCT05853900
COMPLETED
NA
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
NCT01248468
COMPLETED
PHASE4
Therapy for Migraine Prevention in Children 6-11 Years of Age
NCT04050293
TERMINATED
PHASE4