Summary
Tizanidine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Migraine would be drug repurposing rather than first-in-human development. This does not mean it is approved for Migraine. ClinicalTrials.gov lists 2 registered trials linking Tizanidine Hydrochloride to Migraine: 1 is currently recruiting; 1 has completed. The most advanced is Phase 3 (NCT05484349). The largest enrolment is 300 participants (NCT02403687). Registration activity spans 2015 to 2023. No published literature item is linked to Tizanidine Hydrochloride and Migraine in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Migraine Disorder ranks 377 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Migraine frequency fluctuates; spontaneous remission (no attacks for 12+ months) occurs in ~25% over 10-year follow-up; 40% of migraine sufferers qualify for preventive therapy but only 3-13% receive it.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 27.5 (trials 7.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | agonist |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA2B |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05484349 | TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME） 2023 | recruiting | Phase 3 | 189 |
| NCT02403687 | Prospective Analgesic Compound Efficacy (PACE) Study 2015 | completed | Not applicable | 300 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: agonist.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2B. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Tizanidine Hydrochloride approved for Migraine?
Tizanidine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Migraine would be drug repurposing rather than first-in-human development. This does not mean it is approved for Migraine. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tizanidine Hydrochloride in clinical trials for Migraine?
ClinicalTrials.gov lists 2 registered trials linking Tizanidine Hydrochloride to Migraine: 1 is currently recruiting; 1 has completed. The most advanced is Phase 3 (NCT05484349). The largest enrolment is 300 participants (NCT02403687). Registration activity spans 2015 to 2023.
What does the evidence show for Tizanidine Hydrochloride in Migraine?
Tizanidine Hydrochloride has 1 completed registered trial for Migraine but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2B. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.