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NCT05484349
TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Phase 3 trial testing Tizanidine Hydrochloride in Migraine Without Aura in 189 participants. Currently enrolling.
25 December 2025
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 189 |
| Start date | 1 June 2023 |
| Primary completion | 25 December 2025 |
| Estimated completion | 25 December 2025 |
| Sites | 6 locations across China |
Drugs / interventions tested
- Tizanidine Hydrochloride — full drug profile →
- Tizanidine Hydrochloride — full drug profile →
- Tizanidine Hydrochloride Placebo
Conditions studied
- Migraine Without Aura — all drugs for Migraine Without Aura →
- Migraine With Aura — all drugs for Migraine With Aura →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 18 to 65, any sex, with Migraine Without Aura or Migraine With Aura. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05484349
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Migraine Without Aura
Currently open trials in the same condition.
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- NCT05903027 — Gepant treAtments: EffectIveNess and tolERability (GAINER) · recruiting
- NCT04715685 — Mind Body Balance for Pediatric Migraine · NA · recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05484349 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 1 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05484349.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing