Actively Recruiting
TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-01
189
Participants Needed
6
Research Sites
134 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
S
Sichuan Credit Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with migraine with or without aura with at least 1 year history
- Migraine onset before age 50
- 4 to fewer than 15 migraine days per month in the past 3 months
- Less than 15 headache days per month in the past 3 months
- Willing to use effective contraception during the study and for 28 days after
- Able to understand and complete study procedures and consent
- During baseline period: 4 to fewer than 14 migraine days and fewer than 14 headache days in 4 weeks
- Completed at least 80% of electronic headache diary in baseline period
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Diagnosed with possible migraine or other primary/secondary headaches other than migraine
- Previous ineffective use of more than two types of migraine preventive drugs
- Use of prohibited drugs or therapies within 2 months before baseline
- Planned Botulinum toxin treatments during study or within 4 months before screening
- Use of multiple migraine preventive drugs within 2 months before baseline
- Frequent use of certain headache medications exceeding specified limits before baseline
- Use of certain interacting drugs or traditional medicines
- Active chronic pain syndromes
- History of serious mental illness or PHQ-9 score 15 or higher
- Serious neurological disorders other than migraine
- History of malignant tumors within 5 years except certain skin and breast cancers
- Abnormal liver or kidney lab values beyond set limits
- History of heart disease or related cardiovascular conditions
- Medical conditions or risks that may affect safety or study results
- Risk of self-harm or harm to others
- History of drug or alcohol abuse within 12 months
- Pregnant or breastfeeding women or those unwilling to use contraception
- Recent participation in other clinical trials
- Allergy to Tizanidine Hydrochloride or its ingredients
- Unable to maintain stable diet and lifestyle during study
- Planned use of estrogen or progesterone drugs during study
- Researchers involved in the study or their immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Not Yet Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
3
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
4
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
5
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Actively Recruiting
6
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, China
Active, Not Recruiting
Research Team
K
Kaiming Liu, MD & PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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