Actively Recruiting

Phase 3
Age: 16Years +
All Genders
NCT07097701

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Led by Lupin Ltd. · Updated on 2025-12-22

24

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

Sponsors

L

Lupin Ltd.

Lead Sponsor

L

Lupin Atlantis Holdings S.A.

Collaborating Sponsor

AI-Summary

What this Trial Is About

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR compared to Mexiletine IR in Patients with Non-Dystrophic Myotonias (ACHILLES study)

CONDITIONS

Official Title

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and sign informed consent (or parent/guardian consent and patient assent if under 18)
  • Genetically confirmed non-dystrophic myotonias including myotonia congenita, paramyotonia congenita, or sodium channel myotonia
  • Male or non-pregnant female aged 16 years or older
  • Body mass index between 18.5 and 30 kg/m2 and weight at least 45 kg
  • Female participants of childbearing potential must use effective birth control during the study and for 30 days after last dose; male participants must also use birth control during this period
  • No significant cardiac abnormalities by ECG and echocardiogram within 3 months before study entry
  • Myotonic symptoms severe enough to require treatment, as judged by the study investigator
  • Presence of clinical handgrip myotonia (delayed grip relaxation of 3 seconds or more) at screening (for treatment-na�efve patients) and on Day 1 pre-dose for all patients
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Uncontrolled diabetes, recent cancer (except certain skin cancers), multiple sclerosis, seizure disorders, serious illness, or other conditions that may prevent study participation or compliance
  • Severe kidney impairment (GFR less than 30 mL/min)
  • Medical problems affecting muscle function like infections, trauma, fractures, or planned surgery
  • Conditions affecting hand function such as rheumatoid arthritis, Dupuytren's contracture, or hand deformities
  • Severe arthritis or other medical conditions significantly affecting walking ability
  • Severe liver impairment or elevated liver tests over 3 times normal levels
  • Electrolyte imbalances (potassium, magnesium, calcium) that increase heart risks
  • Use of other anti-myotonic treatments within 4 weeks before baseline or 5 half-lives of the drug
  • Use of medications that increase cardiac risk or adverse reaction risk
  • Allergy to mexiletine or related anesthetics
  • Participation in another interventional clinical study within the last 3 months or 5 half-lives of that study drug
  • Wheelchair-bound or bedridden status
  • Any cardiac safety concerns detected during screening
  • Current smokers within one month before screening
  • For treatment-na�efve subgroup: previous mexiletine treatment excluded
  • For previous mexiletine treatment subgroup: treatment within one week before baseline excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Leuven"UZ Leuven Gasthuisberg Campus Herestraat 49 Leuven, 3000"

Leuven, Belgium

Actively Recruiting

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Research Team

N

Nikki Adetoro

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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