Better treatment of muscle diseases

Conditions: Myotonia is a symptom seen certain inherited muscle dystrophies and pure channelopathies (Dystrophia myotonica type 1 and 2, Myotonia Congenita, Paramyotonia Congenita, Hyperkalæmisk periodic paralysis and Potassium-Aggravated myotonia). Genetically, mutations in chloride, sodium or calcium ion channels in the muscle is present. Myotonia manifests during physical activity where the muscle can locks in the middle of a movement. Patients are limited in their physical as well as social activities.
MedDRA version: 14.1Level: PTClassification code 10061533Term: MyotoniaSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-003309-24-DK

Lead Sponsor: Grete Andersen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1 Age over 18 years, both men and women.
2 Clinical myotoni: Myotoni that affect patient performance of activities of daily living (chewing function, handshake initiation of walking and running or to let go of objects) or patients who are treated with antimyotom medicine.
3 Gen-verified diagnosis with either myotonia Congenita, Paramyotonia Congenita, Potassium-Aggravated myotonia and dystrophy Myotonica type 1
4 Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1 In treatment with medicines affecting the study results, estimated by the investigators. Or participated in the drug trial within 30 days prior to study start.
2 Known intolerance or allergy to Lamotrigine.
3 Significant renal or liver function, epilepsy, or long QT interval on the ECG.
4 Pregnancy and breast-feeding.
5 After the investigators discretion.
Mexiletine treatment within 60 hours before study start and serum Mexilitin in therapeutic level will defer study start.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Document that Lamotrigin is an effective treatment of myotonia ;Secondary Objective: Not applicable;Primary end point(s): Patient Evaluated muscle stiffness assessed by Myotonia Behavior scale (MBS);Timepoint(s) of evaluation of this end point: Evaluated 4-7 days in before treatment, at dosis 150 mg, and at dosis 300 mg.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) clinical evaluation of Myotonia by four test: eye-opening, hand-grip, 14-step-stair, and time-up-and-go (TUG).<br>2) Use of escape medicin<br>3) health questionnaire (SF-36);Timepoint(s) of evaluation of this end point: 1) before treatment, after dosis 150 mg and after dosis 300 mg<br>2) doing treatment periods (10 weeks)<br>3) before and after a treatment period