To evaluate the efficacy and safety of tizanidine hydrochloride tablets in the prevention and treatment of migraine - a multicenter, single-arm, self-controlled before-after clinical study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500107287

Enrollment

Unknown

Registered

2025-08-07

Start date

2025-08-15

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine

Interventions

tizanidine hydrochloride tablets:Take tizanidine hydrochloride tablets orally, 2mg each time, three times a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients, aged between 18 and 75 years. 2. 1-year history of migraine with or without aura according to the International Classification of Headache Disorders. 3. Migraine onset before the age of 50. 4. History of migraine for 4 to 14 days per month during the previous 3 months and baseline.

Exclusion criteria

Exclusion criteria: 1. History of chronic migraine, new onset persistent daily headache, number of headache days per month during the 3 months prior to trigeminal autonomic headache or during baseline>=15 days. 2. History of poor response to 3 or more medications used for the prophylactic treatment of migraine. 3. Use of illicit drugs, opioids, or barbiturates. 4. Triptans or ergots >=10 days/month or simple analgesics (aspirin, NSAIDs, acetaminophen) >=15 days/month. 5. Abnormal blood routine or electrocardiogram (ECG) results at baseline. 6. History of medications within the past 3 months or current use of the calcitonin gene-related peptide (CGRP) pathway. 7. Changes in prophylactic treatment in the past 3 months. 8. Use of injectable botulinum toxin within 6 months prior to the first visit. 9. Have major depressive disorder or suicidal tendencies. 10. Use drugs that interact with tizanidine hydrochloride tablets (paracetamol, ethanol, etc., please refer to the drug instructions for tizanidine hydrochloride tablets for details).1. History of chronic migraine, new onset persistent daily headache, number of headache days per month during the 3 months prior to trigeminal autonomic headache or during baseline>=15 days. 2. History of poor response to 3 or more medications used for the prophylactic treatment of migraine. 3. Use of illicit drugs, opioids, or barbiturates. 4. Triptans or ergots >=10 days/month or simple analgesics (aspirin, NSAIDs, acetaminophen) >=15 days/month. 5. Abnormal blood routine or electrocardiogram (ECG) results at baseline. 6. History of medications within the past 3 months or current use of the calcitonin gene-related peptide (CGRP) pathway. 7. Changes in prophylactic treatment in the past 3 months. 8. Use of injectable botulinum toxin within 6 months prior to the first visit. 9. Have major depressive disorder or suicidal tendencies. 10. Use drugs that interact with tizanidine hydrochloride tablets (paracetamol, ethanol, etc., please refer to the drug instructions for tizanidine hydrochloride tablets for details).

Design outcomes

Primary

Measure	Time frame
Record of Headache attack;	—

Countries

China

Contacts

Public ContactZheman Xiao

Renmin Hospital of Wuhan University

zmxiao@whu.edu.cn+86 139 7148 1352

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026