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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT01939561 |
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Date of registration:
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23/08/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lamotrigine as Treatment of Myotonia
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Scientific title:
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Lamotrigine as Treatment of Myotonia - a Phase 3 Randomized Controlled Trial Study |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01939561 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Grete Andersen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen Neuromuscular Center, Rigshospitalet, Denmark, Europe |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical myotonia: Myotonia affecting patients daily life, such as chewing function,
handshake, initiation of walking and running, or dropping objects. Patients in
antimyotonic treatment.
- Gen-verified diagnosis: Myotonia Congenita, Paramyotonia Congenita,
Potassium-aggravated Myotonia or Dystrophia Myotonica type 1.
Exclusion Criteria:
- In treatment with medicines affecting the study results, estimated by investigators.
- Participated in other drug-trials within 30 days prior to study start.
- Known intolerance or allergy to Lamotrigine.
- Significant renal or liver function, epilepsy, or long QT interval on the ECG.
- Pregnancy and breast-feeding.
- After the investigators discretion
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dystrophia Myotonica Type 1
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Hyperkalemic Periodic Paralysis
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Potassium-Aggravated Myotonia
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Myotonia Congenita
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Paramyotonia Congenita
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Intervention(s)
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Drug: Lamotrigine
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Drug: Placebo
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Primary Outcome(s)
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change from baseline in Myotonia Behavior Scale (MBS)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Change from baseline in evaluation of Myotonia
[Time Frame: 8 weeks]
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change from baseline in the SF-36 questionnaire
[Time Frame: 8 weeks]
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average in use of escape medicine
[Time Frame: 8 weeks]
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Secondary ID(s)
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2013-003309-24
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2013-MY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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