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Lamotrigine as Treatment of Myotonia

NCT01939561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-04-25

No results posted yet for this study

Summary

Myotonia is a functional limiting symptom where the muscle stiffens on action leading to arrest of movement. Pharmacological treatment may make the difference between a physically restricted and a normal life. Today, patients with myotonia are treated with Mexiletine a medications resulting in adverse events up to 40 % and which very expensive and difficult to obtain.

Our clinic has, forced by the above problems related to Mexiletine, treated a few patients with the drug Lamotrigine with pronounced positive effect in all. Lamotrigine belongs to the same category of drugs as Mexiletine but has fewer and milder side effects. Based on the similarities of the 2 drugs in pharmacological action and the positive experiences investigators are convinced that Lamotrigine will show a positive effect if evaluated in a broader scale. Due to the advantages of Lamotrigine compared to Mexiletine investigators find it of outmost importance for patients that this drug is assessed formally to establish Lamotrigine as a treatment choice for myotonia. Investigators believe that this will potentially make a huge difference in life quality for persons with myotonia. Investigators aim at investigating the efficacy and tolerability of Lamotrigine in the treatment of myotonia in a randomized doublet blinded placebo controlled crossover study.

Conditions

  • Dystrophia Myotonica Type 1
  • Myotonia Congenita
  • Paramyotonia Congenita
  • Hyperkalemic Periodic Paralysis
  • Potassium-Aggravated Myotonia

Interventions

DRUG

Lamotrigine

DRUG

Placebo

Placebo is tablets identically with the Lamotrigine tablets.

Sponsors & Collaborators

  • Grete Andersen, MD

    lead OTHER

Principal Investigators

  • Grete Andersen, MD · Copenhagen Neuromuscular Center, Rigshospitalet, Denmark, Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01939561 on ClinicalTrials.gov