Tizanidine
| Evidence Level: L2 | Predicted Indications: 5 |
Table of Contents
Tizanidine: Migraine disorder
One-Sentence Summary
Tizanidine is a centrally acting alpha-2 adrenergic agonist, marketed in India in 15 single-ingredient licences. The TxGNN model predicts it may be effective for migraine disorder, with 1 Phase 3 trial (no results available) and a randomized placebo-controlled trial in chronic daily headache supporting this direction. The evidence level is L2.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9979 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (15 of 15) – CDSCO approval status is not included in this data |
| Number of Listed Products | 15 (valid: 15) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Tizanidine is a central alpha-2 adrenergic agonist. It is thought to reduce migraine frequency by modulating trigeminal and brainstem pain transmission, and by lowering neck and head muscle tension, which may contribute to chronic daily headache.
The strongest direct clinical evidence comes from chronic daily headache rather than episodic migraine. A double-blind, placebo-controlled, multicentre trial tested tizanidine as add-on preventive therapy in chronic daily headache, a group that includes chronic migraine (PMID 12167135). Several reviews also list tizanidine among preventive options for chronic migraine and chronic daily headache. A Phase 3 trial in episodic migraine prevention is registered, but no results are available yet.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT05484349 | Phase 3 | Unknown | 189 | Multicentre, randomized, double-blind, placebo-controlled study of oral tizanidine for preventing migraine attacks in adults aged 18-65; no results verified |
One further registered study (NCT02403687, a topical analgesic observational study) has no clear link to tizanidine or migraine and is not listed.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12167135 | 2002 | RCT | Headache | Double-blind, placebo-controlled multicentre study of tizanidine as add-on prophylaxis in chronic daily headache (chronic migraine, migrainous headache, tension-type headache) |
| 11318882 | 2001 | Open-label study | Headache | Open-label dose-titration study of efficacy and tolerability of tizanidine tablets in chronic daily headache prophylaxis |
| 20464578 | 2010 | Review | Neurol Sci | Review of double-blind placebo-controlled trials of chronic migraine prophylaxis |
| 12696998 | 2003 | Review | CNS Drugs | Muscle-tone agents (baclofen, tizanidine, botulinum toxin A) as preventive treatment for migraine and tension-type headache |
| 15115635 | 2004 | Review | Curr Pain Headache Rep | New migraine preventive options, including tizanidine |
| 17115988 | 2006 | Review | Headache | Prophylactic treatment of chronic daily headache; tizanidine among the agents with some evidence |
| 31365643 | 2019 | Consensus guideline | Arq Neuropsiquiatr | Brazilian Headache Society consensus on chronic migraine treatment |
| 11903539 | 2002 | Clinical report | Headache | Low-dose tizanidine with NSAIDs for detoxification from analgesic rebound headache |
| 40983294 | 2025 | Preclinical/formulation | J Control Release | Tizanidine–meloxicam co-assembly designed to enhance anti-migraine effect |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 217069 | Tizan 4mg Tablet (Sun Pharmaceutical) | Strip of 10 tablets | Not stated |
| 214866 | Tizan 2 Tablet (Sun Pharmaceutical) | Strip of 10 tablets | Not stated |
| 199785 | Sirdalud 2mg Tablet (Novartis India) | Strip of 6 tablets | Not stated |
| 138570 | Myodine 2mg Tablet (Bangalore Antibiotics & Biologicals) | Strip of 10 tablets | Not stated |
| 97202 | Ginox Tablet (Gold Line) | Strip of 10 tablets | Not stated |
All 15 single-ingredient licences are currently valid; the five above are shown as examples.
Safety Considerations
- Drug Interactions: 249 interactions are recorded. Major-level interactions include famotidine, cimetidine, morphine, dolasetron and obeticholic acid. Moderate-level examples include clarithromycin, levofloxacin, metoclopramide, atropine and naltrexone. CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin deserve particular attention.
- Other concerns: Sedation, low blood pressure and liver toxicity risk call for monitoring. Liver failure, kidney disease, psychotic and other mental disorders, and hypotensive disorders are listed as conditions of concern for this drug.
Please also refer to the package insert, as label warnings and contraindications are not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A randomized placebo-controlled trial in chronic daily headache (most participants had migraine) and a registered Phase 3 migraine prevention trial support the prediction (Evidence Level L2). However, the Phase 3 trial has no verified results, and the best direct evidence is in chronic daily headache rather than episodic migraine.
To proceed, the following is needed:
- Results from the Phase 3 trial NCT05484349 in episodic migraine
- Package insert warnings and contraindications
- Detailed mechanism of action data
- A safety plan covering sedation, hypotension, liver monitoring and CYP1A2-related interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.