Migraine Aura: Updates in Pathophysiology and Management.
Joshua Lai, Esma Dilli
https://pubmed.ncbi.nlm.nih.gov/32430657Actively Recruiting
Phase 3
Age: 18Years - 65Years
All Genders
ID05484349
Safety and Efficacy of Oral Tizanidine Hydrochloride in Preventing Migraine Attacks in Adult Migraine Patients: a Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-01
189
Participants Needed
6
Research Sites
N/A
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
Researchers are evaluating Tizanidine Hydrochloride for preventing migraine attacks in adults who experience episodic migraine, including those diagnosed with migraine without aura and migraine with aura. The study aims to assess the safety, tolerability, and effectiveness of this oral medication in reducing migraine days over a 12-week treatment period. The trial is a multicenter, randomized, double-blind, placebo-controlled study enrolling 189 adult patients aged 18 to 65 with a migraine history of at least one year. Participants are randomly assigned to one of three groups: Tizanidine Hydrochloride 1 mg three times daily, Tizanidine Hydrochloride 2 mg three times daily, or a placebo tablet three times daily. The medication is taken orally for 12 consecutive weeks, followed by a 12-week follow-up period. The study includes a screening and baseline phase of 4 weeks before treatment, a 12-week double-blind treatment phase, and a 4-week follow-up phase, totaling approximately 20 weeks. During the study, participants attend face-to-face visits at weeks 4, 8, 12, and 16 after starting the medication. Researchers collect data through electronic headache diaries, questionnaires measuring headache frequency, severity, disability, and quality of life, as well as monitoring safety and tolerability. The primary measure is the change in migraine days during the 12-week treatment. Secondary measures include headache intensity, medication use, and various quality of life and mental health assessments. Safety monitoring and data quality procedures follow strict clinical research guidelines.
CONDITIONS
Brief Title
TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Diagnosed with migraine with or without aura for at least 1 year
- Migraine started before age 50
- Experience 4 to less than 15 migraine days per month within 3 months before screening
- Less than 15 headache days per month within 3 months before screening
- Willing to use effective contraception during the study and 28 days after last dose
- Able to complete at least 80% of electronic headache diary during baseline period
- Agree to participate and sign informed consent
- Have 4 to less than 14 migraine days within 4 weeks of baseline period
- Have less than 14 headache days within 4 weeks of baseline period
You will not qualify if you...
- Diagnosed with possible migraine or other primary/secondary headaches besides migraine
- Previous ineffective use of more than two migraine preventive drugs from specified categories
- Use of prohibited drugs or therapies within 2 months before baseline or during baseline
- Planned botulinum toxin injections during study or within 4 months before screening
- Use of two or more migraine preventive drugs within 2 months before baseline or during baseline
- Frequent use of ergotamines, triptans, NSAIDs, opioids, or barbiturates before baseline
- Use of certain medications that may interfere with study drug
- Active chronic pain conditions
- History of serious mental illness or high depression score
- Serious neurological disorders other than migraine
- History of malignant tumors within 5 years (with exceptions)
- Abnormal liver or kidney function tests at screening
- History of heart disease or stroke
- Risk of self-harm or harm to others
- Recent history of substance abuse
- Pregnant or breastfeeding women
- Unwilling to use contraception if of childbearing potential
- Participation in other clinical trials within 3 months
- Allergy to Tizanidine or its ingredients
- Unable to maintain usual diet and lifestyle during study
- Intend to take estrogen or progesterone during study
- Researcher or immediate family member involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take oral Tizanidine Hydrochloride or placebo three times daily for 12 consecutive weeks to prevent migraine attacks.
Face-to-face visits at weeks 4, 8, and 12 during treatment
Follow-up
Duration - 4 weeks
Participants are monitored for 4 weeks following treatment to assess safety and lasting effects.
1 face-to-face visit at week 16 after dosing
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
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Research Team
K
Kaiming Liu, MD & PHD
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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Published Research Related To This Trial
Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators
https://pubmed.ncbi.nlm.nih.gov/30496104Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.
GBD 2016 Headache Collaborators
https://pubmed.ncbi.nlm.nih.gov/30353868Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.
GBD 2016 Neurology Collaborators
https://pubmed.ncbi.nlm.nih.gov/30879893The prevalence and burden of primary headaches in China: a population-based door-to-door survey.
Shengyuan Yu, Ruozhuo Liu, Gang Zhao...
https://pubmed.ncbi.nlm.nih.gov/22590713Health-care utilization for primary headache disorders in China: a population-based door-to-door survey.
Ruozhuo Liu, Shengyuan Yu, Mianwang He...
https://pubmed.ncbi.nlm.nih.gov/23731663A satisfaction survey of current medicines used for migraine therapy in China: is Chinese patent medicine effective compared with Western medicine for the acute treatment of migraine?
Ning Luo, Weiwei Qi, Can Zhuang...
https://pubmed.ncbi.nlm.nih.gov/24524844