drugset / Trial / NCT05484349
TIzanidine for the Preventive Treatment of Episodic MigrainE (TIME)
Phase 3
Recruiting
189 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sichuan Credit Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2023-06-01
- Primary completion
- 2025-12-25
- Completion
- 2025-12-25
Publications
- Results Lai J, Dilli E. Migraine Aura: Updates in Pathophysiology and Management. Curr Neurol Neurosci Rep. 2020 May 19;20(6):17. doi: 10.1007/s11910-020-01037-3.
- Results GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. 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. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Results GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
- Results GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
- Results Yu S, Liu R, Zhao G, Yang X, Qiao X, Feng J, Fang Y, Cao X, He M, Steiner T. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012 Apr;52(4):582-91. doi: 10.1111/j.1526-4610.2011.02061.x.
- Results Liu R, Yu S, He M, Zhao G, Yang X, Qiao X, Feng J, Fang Y, Cao X, Steiner TJ. Health-care utilization for primary headache disorders in China: a population-based door-to-door survey. J Headache Pain. 2013 Jun 3;14(1):47. doi: 10.1186/1129-2377-14-47.
- Results International Headache Congress (IHC), Dublin, Ireland; September 5th-8th, 2019.
- Results Luo N, Qi W, Zhuang C, Di W, Lu Y, Huang Z, Sun Y, Zhang A, Huang X, Tao Y, Zhu Y, Li A, Jiang Z, Massing MW, Fang Y. A 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? Pain Med. 2014 Feb;15(2):320-8. doi: 10.1111/pme.12277. Epub 2013 Nov 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tizanidine | Small molecule | 1 mg | Oral |
| Subject | Tizanidine | Small molecule | 2 mg | Oral |