Last reviewed · How we verify
NCT04700046: MIND
Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2
Phase 3 trial testing Mexiletine 167 mg in Myotonic Dystrophy Type 1 and Type 2. Withdrawn.
1 July 2024
Quick facts
| Lead sponsor | Lupin Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 3 September 2021 |
| Primary completion | 1 July 2024 |
| Estimated completion | 12 August 2024 |
Drugs / interventions tested
- Mexiletine 167 mg — full drug profile →
- Placebo
Conditions studied
- Myotonic Dystrophy Type 1 and Type 2 — all drugs for Myotonic Dystrophy Type 1 and Type 2 →
Sponsor
Lupin Ltd. — full company profile →
Who can join
18 and older, any sex, with Myotonic Dystrophy Type 1 and Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Mexiletine During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 \[The MIND Study\]
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multisystem Symptoms in Myotonic Dystrophy Type 1: A Management and Therapeutic Perspective.
Kuntawala DH, Vitorino R, Cruz AC, Martins F, et al · · 2025 · cited 4× · PMID 40508159 · DOI 10.3390/ijms26115350 -
Expert Insights from a Delphi-driven Neurologists' Panel: Real-world Mexiletine use in Patients with Myotonic Disorders in Italy.
Lidonnici D, Brambilla P, Ravasio R, Zozulya-Weidenfeller A, et al · · 2024 · cited 2× · PMID 38306059 · DOI 10.3233/jnd-230115
Verify or expand the search:
- PubMed search for NCT04700046
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Lupin Ltd. trials
Trials by the same sponsor.
- NCT07154654 — Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders · recruiting
- NCT06549400 — An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With · Phase 3 · enrolling by invitation
- NCT07097701 — An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexileti · Phase 3 · recruiting
- NCT06523400 — The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 · Phase 3 · recruiting
- NCT04622553 — Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. · NA · active not recruiting
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 NCT04700046 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lupin Ltd.
- Last refreshed: 6 May 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/NCT04700046.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing