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Mexiletine in Non-Dystrophic Myotonia
NCT00832000Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2008
- Primary completion
- Mar 2011
- Countries
- 4
- Modality
- Orthosteric Ligands
- Drugs
- mexiletine
- Conditions
- non-dystrophic myotonia (NDM)
01
Overview
Phase 2, randomised, double-blind trial in non-dystrophic myotonia (NDM) comparing Mexiletine First with Placebo First (2 arms). Primary endpoint: Patient-reported Stiffness on the IVR. Started Dec 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Mexiletine First
Mexiletine -> Washout -> Placebo
Placebo First
Placebo -> Washout -> Mexiletine
03
Who it enrols
Patients with clinical symptoms or signs of myotonic disorders and myotonic potentials on EMG. Excludes patients with DM1/DM2, cardiac conduction defects, or use of certain antiarrhythmic or myotonia-inducing medications.
04
Endpoints
Primary
Patient-reported Stiffness on the IVR
Secondary
Patient Reported Pain on the IVR
Patient Reported Weakness on the IVR
Patient Reported Tiredness on the IVR
Quantitative Measure of Hand Grip Myotonia
Compound Motor Action Potentials After Short Exercise Test
Graded Myotonia by Needle Electromyography - Right Abductor Digiti Minimi
Clinical Hand Grip Myotonia Evaluation
Clinical Eye Closure Myotonia Evaluation
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