Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial

Phase 2

• Conditions: Spinal and Bulbar Muscular Atrophy

• Registration Number: JPRN-UMIN000026150
• Lead Sponsor: agoya University Graduate School of Medicine

Brief Summary

In the MEXPRESS trial, 20 participants took mexiletine or lactose, three times a day for 4 weeks with a crossover design. There was no difference in distal latencies at room temperature and under cold exposure between mexiletine and placebo groups as the primary endpoint. However, tongue pressure and 10-sec grip and release test under cold exposure were improved in the mexiletine group. There were no serious adverse events throughout the study period.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-31
• Study Completion: 2018-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who have hypersensitivity for this medicine 2. Patients who have second degree atrioventricular block, third degree atrioventricular block, or left bundle branch block 3. Patients who show Brugada-type ECG 4. Patients who have past history of myocardial infarction, valvular disease, or cardiomyopathy 5. Patients whose heart rate is 50 /min or less 6. Patients who have severe liver or renal dysfunction 7. Patients who have heart failure 8. Patients whose systolic blood pressure is 90mmHg or less 9. Patients who have parkinsonism 10. Patients whose serum potassium level is 3.5mEq/l or less 11. Patients who take anti-arrhythmic drug 12. Patients who take anti-epileptic drug 13. Patient who have neurological disorders except for SBMA 14. Patients whose HbA1c(NGSP) level is 6.5% or more 15. Patients who take hypoglycemic drugs 16. Patients who are alcohol addicts 17. Patients who are drug addicts 18. Patients who take cimetidine, rifampicin, or theophylline 19. Patients who have severe complication 20. Patients whose grip power of dominant hand is less than 10kg 21. Patients who are judged to be inappropriate to participate in the trial by any other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified