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Treatment of Myotonia - Lamotrigine Versus Namuscla

NCT05639257 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-12-06

No results posted yet for this study

Summary

In this clinical study, the aim is to investigate whether there is a difference in treatment of myotonia using two drugs. A difference there can justify the significantly higher cost when treated by Namuscla versus Lamotrigine.

According to the current corona pandemic, the investigators designed an app to use for data collection in the study. The app also ensures that patients who live far from the clinic more easily can participate.

Conditions

  • Non-Dystrophic Myotonia

Interventions

DRUG

Lamotrigine

Lamotrigine tablets increasing dosis to maximal 300 mg daily

DRUG

Namuscla

Namuscla tablets increasing dosis to maximal 501 mg daily

Sponsors & Collaborators

  • GCP-Copenhagen

    collaborator UNKNOWN

  • Region Capital Denmark

    collaborator OTHER

  • Danish Region

    collaborator UNKNOWN

  • Lupin Atlantis Holdings S.A.

    collaborator UNKNOWN

  • ZiteLab

    collaborator UNKNOWN

  • Grete Andersen, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • Denmark

Study Locations

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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 NCT05639257 on ClinicalTrials.gov