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New treatment option for Migraine Without Aura
Official title TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
ClinicalTrials.gov ID: NCT05484349
What this study is testing
What is Tizanidine Hydrochloride?
Tizanidine Hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine without aura.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must meet all of the following to participate in this study.
- The age at entry for trails involving adult people is 18-65 years (including both ends)；
- According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine...
- The age at first migraine onset should be \<50 years;
- Migraine attacks ≥ 4 days/month and \< 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
You likely can't join if
- people with any of the following cannot participate in this study:
- Subject diagnosed with possible migraine according to ICHD-3(2018);
- Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are...
- 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
See the full eligibility criteria
Who can join
- people must meet all of the following to participate in this study.
- The age at entry for trails involving adult people is 18-65 years (including both ends)；
- 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...
- The age at first migraine onset should be \<50 years;
- Migraine attacks ≥ 4 days/month and \< 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
- 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);
- 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;
- 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...
- Migraine days ≥4 and \<14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);
- Headache days \< 14 days within 4 weeks of baseline period;
- 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...
- 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 assigned by chance, blinded, compared with an...
What rules you out
- people with any of the following cannot participate in this study:
- Subject diagnosed with possible migraine according to ICHD-3(2018);
- 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);
- 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...
- Lack of sustained response to medication;
- Can not be tolerated dose of drug
- 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);
- people 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;
- 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...
- 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
- Fluvoxamine, ciprofloxacin (cytochrome oxidase P450IA2 inhibitor), fluoroquinolones, zileuton, antiarrhythmics (amiodarone, mexiletine, propafenone, and verapamil) , cimetidine, famotidine, acyclovir, ticlopidine...
- Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);
- Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；people PHQ-9 score\<15 are allowed to enter the blinded treatment period if they had a history of anxiety or depression...
- Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);
- 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;
- 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 （people with diagnosed Gilbert syndrome excluded）,or
- The creatinine clearance rate is less than 25 mg/min, and the creatinine clearance rate decreases by 50%;
- Previous heart disease, heart failure, bradycardia, orthostatic hypotension and other types of hypotension, stroke, transient ischemic attack (TIA);
- 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...
- According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;
- 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;
- people expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;
- During the study period, female people 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:\ 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
- people who participated in other clinical trials within 3 months before the screening period;
- .people who are allergic to tizanidine hydrochloride or tizanidine hydrochloride excipients;
- people who cannot maintain their original diet and living habits during the trial;
- people who intend to take estrogen and/or progesterone drugs during the screening period or after enrollment;
- Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).
The study team makes the final eligibility decision.
Where it's taking place
- Luzhou, Sichuan, China
- Hangzhou, Zhejiang, China
- Jiaxing, Zhejiang, China
- Shaoxing, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luzhou, Sichuan, China; Hangzhou, Zhejiang, China; Jiaxing, Zhejiang, China; Shaoxing, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.