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Recruiting Phase 3 NCT05484349

TIzanidine for the Preventive Treatment of Episodic MigrainE (TIME)

Trial Parameters

Condition Migraine Without Aura
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 189
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-06-01
Completion 2025-12-25
Interventions
Tizanidine HydrochlorideTizanidine HydrochlorideTizanidine Hydrochloride Placebo

Brief Summary

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

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to participate in this study. 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

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