Better treatment of muscle diseases

• Register: EUCTR
• Last refreshed on: 22 December 2015
• Main ID: EUCTR2013-003309-24-DK
• Date of registration: 21/10/2013
• Prospective Registration: Yes
• Primary sponsor: Grete Andersen
• Public title: Better treatment of muscle diseases
• Scientific title: Lamotrigine as treatment of Myotonia
• Date of first enrolment: 28/10/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003309-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark

Contacts

• Name: Clinical trials information
• Affiliation: Grete Andersen, Rigshospitalet 3342

• Name: Clinical trials information
• Affiliation: Grete Andersen, Rigshospitalet 3342

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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: 14.1 Level: PT Classification code 10061533 Term: Myotonia System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: Lamotrigin "actavis"
Pharmaceutical Form: Capsule
INN or Proposed INN: Lamotrigine
Other descriptive name: LAMOTRIGINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25-300
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Not applicable

Main Objective: Document that Lamotrigin is an effective treatment of myotonia

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(s)

Timepoint(s) of evaluation of this end point: 1) before treatment, after dosis 150 mg and after dosis 300 mg
2) doing treatment periods (10 weeks)
3) before and after a treatment period

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).
2) Use of escape medicin
3) health questionnaire (SF-36)

Secondary ID(s)

2013-562

Source(s) of Monetary Support

Rigshospitalet