TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
The age at entry for trails involving adult subjects 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 least 1 year;
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);
Disqualifiers
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);
Type 1: Divalproex, Sodium Valproate
Type 2: Topiramate
Trial design
Treatments tested in this trial
- Tizanidine Hydrochloride
- Tizanidine Hydrochloride
- Tizanidine Hydrochloride Placebo
Treatment groups
189 Participants
are divided into 3 treatment groupsLocations
6The Affiliated Hospital of Southwest Medical University LuzhouSichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine HangzhouZhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine HangzhouZhejiang, China
Zhejiang Provincial People's Hospital HangzhouZhejiang, China
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Sichuan Credit Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov