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Clinical study on prophylactic treatment of migraine with tizanidine

Clinical study on prophylactic treatment of migraine with tizanidine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040075
Enrollment
Unknown
Registered
2020-11-20
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Migraine

Interventions

group of placebo:placebo tid
group of 1mgTizanidine:Tizanidine 1mg tid
group of 2mgTizanidine:Tizanidine 2mg tid

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) In accordance with the diagnostic criteria for migraine with aura and without aura (ICHD-III) of the international society of headache classification (2018) and the standard of preventive treatment of migraine in China's guidelines for prevention and treatment of migraine in 2016; (2) Cranial CT or MRI was negative, and neurologic examination was negative; (3) They are 18-65 years old, male and female; (4) The subjects could accurately understand the researcher's instructions and complete the headache diary independently or with the help of their family members; (5) Voluntary written informed consent

Exclusion criteria

Exclusion criteria: (1) Patients with uncontrolled hypertension were treated with ß - blockers or a - agonists; (2) Severe infection occurred in the past 6 months; (3) Patients with severe cardiovascular disease (severe heart failure, atrial fibrillation, after cardiovascular interventional surgery), cerebrovascular disease (stroke, cerebrovascular malformation), central nervous system infection, intracranial space occupying lesions, or brain trauma and other diseases (4) Patients with severe primary diseases of liver and kidney hematopoietic system; (5) Patients with cervical spondylosis, otogenic, rhinogenic, odontogenic and other secondary headache; (6) Migraine belongs to drug overuse headache and other special types of migraine (such as ophthalmoplegia, hemiplegia, etc.); (7) In recent 6 months, he has taken other drugs to prevent migraine attack systematically; (8) Combination of alcohol or other drug abusers; (9) Patients with severe mental illness, depression or anxiety disorder; (10) Participants in other clinical trials during the period of participating in this trial; (11) Allergy to the drug or similar drugs; (12) Planned pregnancy, pregnancy and lactation women (13) The investigator judged that it was not suitable to participate in the clinical trial

Design outcomes

Primary

MeasureTime frame
Headache index;

Secondary

MeasureTime frame
Total headache days;Severe headache days;Headache duration;HIT, MIDAS;Frequency of headache related symptoms (nausea and vomiting, fear of sound and photophobia, etc.);Dosage and days of acute analgesic;Remission rate;Detection value of low frequency;

Countries

China

Contacts

Public ContactLei Chen

West China Hospital, Sichuan University

leilei_25@126.com+86 18980605819

Outcome results

None listed

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