Tiapride
| Evidence Level: L2 | Predicted Indications: 1 |
Table of Contents
Tiapride: From an Unspecified Original Indication to Migraine Disorder
One-Sentence Summary
Tiapride is a substituted benzamide (a dopamine D2/D3 receptor antagonist) marketed in India as single-ingredient tablets. The TxGNN model predicts it may be effective for migraine disorder, supported by 8 publications (including 1 randomised, double-blind pilot study and several older controlled studies) but no registered clinical trials in the data compiled for this report.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the approved-indication text of the Indian licences |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9918 |
| Evidence Level | L2 (see note below) |
| India Market Status | Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data |
| Number of Listed Products | 3 (valid: 3) |
| Recommended Decision | Hold |
Note on evidence level: The compiled data assign L2 on the basis of one randomised pilot study and several controlled studies. Strictly under the grading rules, which require a completed Phase 2/3 RCT, this is better read as a low L2 or high L3. The RCT is a small pilot study, and the controlled studies are from the 1980s.
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available from the compiled sources. Based on general pharmacology, tiapride is a selective dopamine D2/D3 receptor antagonist. This rationale is inferred from general knowledge, not from the supplied data.
Dopaminergic activity is thought to contribute to the premonitory symptoms of migraine, such as nausea, yawning and irritability. Central D2 antagonism is a recognised mechanism behind the antiemetic and antimigraine effects of drugs such as metoclopramide and domperidone. Related benzamides such as sulpiride have also been used for migraine prevention.
The original indication is not recorded in the Indian licence data. Tiapride’s mechanism, however, fits migraine well, and this is consistent with the high TxGNN score. The literature below also shows tiapride used for headache and migraine, mostly in older European studies.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35548913 | 2022 | RCT (double-blind pilot) | Revista de neurologia | Compared tiapride with topiramate for prophylaxis of chronic migraine; efficacy and safety were evaluated |
| 6256904 | 1980 | Controlled study | La semaine des hopitaux | In 40 migraine patients, tiapride was reported to be clearly better than placebo |
| 6266020 | 1981 | Controlled trial | La semaine des hopitaux | In 25 patients with intractable migraine or facial vascular pain, results were excellent in 10 |
| 6528587 | 1984 | Clinical study / Review | Wiadomosci lekarskie | Benzamides (sulpiride, tiapride) in preventive migraine treatment (no abstract available) |
| 7323625 | 1981 | Double-blind clinical study | Rivista di patologia nervosa e mentale | In 50 chronic headache patients (300 mg/day for 30 days), 65% had clinical benefit |
| 6293072 | 1982 | Clinical study | La semaine des hopitaux | In 180 patients, mostly with headache, 71% of completers had good or excellent results |
| 39344 | 1979 | Case series | La semaine des hopitaux | Four migraine patients treated for at least 6 months all had excellent or very good results |
| 229563 | 1979 | Case series | La semaine des hopitaux | Geriatric series of 47 patients across various conditions; not specific to migraine |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 216949 | Tiaprex 50mg Tablet | Strip of 10 tablets | Not stated |
| 216114 | Tiaprex 25 Tablet | Strip of 10 tablets | Not stated |
| 220651 | Tiaprex 100mg Tablet | Strip of 10 tablets | Not stated |
All three licences are valid single-ingredient oral products from Intas Pharmaceuticals Ltd.
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found for tiapride in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanistic fit and literature signal are encouraging, and the TxGNN score is very high. However, the human evidence is one small pilot RCT plus mostly decades-old, methodologically limited studies, with no registered trials. Safety information is also unavailable, so a move forward is premature.
To proceed, the following is needed:
- The Indian package insert (warnings, contraindications and approved indications), which is required for safety screening
- Confirmed mechanism of action data from DrugBank
- Full-text appraisal of the 2022 tiapride vs topiramate RCT and the controlled studies from the 1980s
- A safety review for long-term use in migraine prophylaxis, including dopamine-antagonist class effects
- Evaluation of whether a confirmatory, adequately powered randomised trial in migraine is justified
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.