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TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）

NCT05484349 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2024-08-01

No results posted yet for this study

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.

Conditions

  • Migraine Without Aura
  • Migraine With Aura

Interventions

DRUG

Tizanidine Hydrochloride

Tizanidine Hydrochloride 1 mg Tid for 12 consecutive weeks and were followed up for 12 weeks

DRUG

Tizanidine Hydrochloride

Tizanidine Hydrochloride 2 mg Tid for 12 consecutive weeks and were followed up for 12 weeks

DRUG

Tizanidine Hydrochloride Placebo

Tizanidine Hydrochloride Placebo Comparator 1 tablet Tid for 12 consecutive weeks and were followed up for 12 weeks

Sponsors & Collaborators

  • Sichuan Credit Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Kaiming Liu, MD & PHD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-12-25
Completion
2025-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484349 on ClinicalTrials.gov