Trimebutine
| Evidence Level: L2 | Predicted Indications: 2 |
Table of Contents
- Trimebutine
- Pharmacist Assessment Report
- Trimebutine: From Functional Gastrointestinal Disorders to Migraine Disorder
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Trimebutine: From Functional Gastrointestinal Disorders to Migraine Disorder
One-Sentence Summary
Trimebutine is a peripheral opioid-receptor agonist that regulates gastrointestinal motility, and it is marketed in India as an oral tablet. The TxGNN model predicts it may be useful for migraine disorder, but the support is limited: no registered clinical trials and 3 publications, only one of which is a randomized trial (an add-on to a triptan).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Indian license record |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9964 |
| Evidence Level | L2 (based on a single small randomized trial; no registered clinical trials) |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Based on general pharmacology, trimebutine acts on peripheral opioid receptors (mu, delta, kappa) in the gut and also modulates gastrointestinal motility and ion channels (calcium and sodium). Its use is mainly in functional gastrointestinal disorders.
A possible link to migraine is modulation of visceral and peripheral pain signalling, or of gut-brain axis signalling. This remains speculative. The very high TxGNN score is a computational prediction and does not establish a mechanism.
The only direct clinical signal is a 2006 double-blind, randomized, cross-over, placebo-controlled study of rizatriptan versus rizatriptan plus trimebutine for acute migraine. Gastroparesis is common during migraine attacks and can delay absorption of oral drugs. A gastrokinetic agent might therefore help the triptan work faster or more consistently. If real, this would be an adjunctive effect rather than an independent antimigraine effect.
A second predicted indication, migraine with brainstem aura, has no trials or literature. Its high score (0.9954) most likely reflects its close relationship to the parent migraine disorder. Triptans are traditionally used with caution in brainstem aura, so extrapolation is weak. It is not evaluated further here.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 16776704 | 2006 | RCT | Cephalalgia | Double-blind, randomized, cross-over, placebo-controlled study of rizatriptan vs. rizatriptan plus trimebutine in acute migraine. Rationale: gastroparesis during attacks delays oral drug absorption; a gastrokinetic may improve triptan efficacy. |
| 19220673 | 2009 | Review | J Gastroenterol Hepatol | Review of prokinetic agents for diseases outside the GI tract, including the central nervous system. |
| 16245431 | 2005 | Case report | Pol Merkur Lekarski | Nine-year-old girl with abdominal migraine who did not improve with drotaverine, mebeverine or trimebutine. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 219665 | Trimspa 200mg Tablet (Macleods Pharmaceuticals Pvt Ltd) | Strip of 6 tablets | Not stated |
Safety Considerations
Please refer to the package insert for safety information. No drug-interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is a computational prediction only. The sole direct evidence is one small 2006 randomized trial suggesting an add-on effect with a triptan, likely through improved gastric motility. There are no registered trials and no confirmed mechanism, so this is best treated as a research question rather than a development candidate.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulator or manufacturer, which are required before safety screening
- Detailed mechanism-of-action data, to test the proposed gut-brain or motility link
- Critical appraisal of the 2006 trial (sample size, endpoints, effect size), and ideally a larger confirmatory trial of trimebutine as a triptan add-on
- Confirmation of the approved indication for the Indian product
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.