NCT05484349

TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）

Safety and Efficacy of Oral Tizanidine Hydrochloride in Preventing Migraine Attacks in Adult Migraine Patients: a Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Migraine Without Aura
• Migraine With Aura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2022-08-02
• Last updated: 2024-08-01

Locations

6 sites across 1 country: China