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Trial record 1 of 10 for:    non-dystrophic myotonias
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MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias (MEND)

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ClinicalTrials.gov Identifier: NCT05017155
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

This is a clinical trial to determine if Lamotrigine is non-inferior to Mexiletine for the treatment of myotonia in patients with Non-Dystrophic Myotonia.

Non-dystrophic Myotonia is a genetic condition for which there is no cure. It affects patients for the duration of their life and impacts work, leisure and can lead to significant morbidity.

The study is a cross-over design - participants will be randomized to either lamotrigine or mexiletine first for 8 weeks and then swap over after a week wash-out to the other medication for a further 8 weeks. Participants and investigators will be blinded to the treatment schedule. 60 participants will recruited through the clinical service, national registry and national liaison.


Condition or disease Intervention/treatment Phase
Non-Dystrophic Myotonia Drug: Mexiletine Drug: Lamotrigine 25Mg Oral Tablet, Extended Release Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be recruited from University College London Hospital (UCLH). After screening and consent, randomisation will occur to one of two arms. The participant will participate in two consecutive time periods. A time period will consist of 8 weeks of Mexiletine or Lamotrigine. The second time period will then occur after 7 days of washout. The patient will then take the alternative drug. Visits will occur at the end of each period and can be undertaken remotely as required. At each visit, the Interactive Voice Response (IVR)-Diary score will be performed and secondary measures including the Brief Pain Inventory, Modified Fatigue Severity Scale and Medical Outcomes Study Questionnaire (SF-36). Objective recordings including Timed up and Go (TUG), Timed Sit to Stand (TST). Safety data will be recorded simultaneously. A participant diary will be utilised to record daily IVR-Diary scores, medication compliance and activity measures.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double Blinded, Head-to-head, Single-site, Cross-over Trial of Lamotrigine Versus Mexiletine for Non-dystrophic Myotonias
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : April 2, 2024


Arm Intervention/treatment
Active Comparator: Lamotrigine
When on the lamotrigine treatment arm, the participant will commence at lamotrigine 25mg (milligram) daily for two weeks; then increase to 25mg twice daily for two weeks; then increase to 50mg daily for one week; then increase to 100mg in the morning, 50mg at midday and 50mg at night for one week; then increase to 100mg in the morning, 50mg at midday and 100mg at night for two weeks.
Drug: Mexiletine
Mexiletine is a sodium channel blocker shown to be effective in reducing myotonia in a multi-centre randomised trial.

Drug: Lamotrigine 25Mg Oral Tablet, Extended Release
Lamotrigine is an alternative sodium channel blocker that has been shown to be effective in one randomised controlled trial. It is currently used as a licensed medication for other neurological conditions.

Active Comparator: Mexiletine
When on the mexiletine treatment arm, the participant will commence at mexiletine 100mg daily for two weeks; then increase to 200mg daily for two weeks; then increase to 200mg twice daily for one week; then increase to 200mg three times a day for one week; then remain on 200mg three times a day for two weeks.
Drug: Mexiletine
Mexiletine is a sodium channel blocker shown to be effective in reducing myotonia in a multi-centre randomised trial.

Drug: Lamotrigine 25Mg Oral Tablet, Extended Release
Lamotrigine is an alternative sodium channel blocker that has been shown to be effective in one randomised controlled trial. It is currently used as a licensed medication for other neurological conditions.




Primary Outcome Measures :
  1. Interactive Voice Response (IVR) -diary score [ Time Frame: Time Frame: last two weeks of each treatment period - [Minimum value 0- no myotonia. Maximum value 9 - severe myotonia]. ]
    Improvement seen on the 9 point Interactive Voice Response (IVR) -diary score


Secondary Outcome Measures :
  1. Secondary Outcome - Timed up and go [ Time Frame: end of each treatment period (two months) ]
    Timed up and go

  2. Secondary Outcome - Timed sit to stand [ Time Frame: end of each treatment period (two months) ]
    Timed sit to stand

  3. Fatigue Scale [ Time Frame: end of each treatment period (two months) ]
    minimum 9 - minimal fatigue. maximum 63 - severe fatigue

  4. Secondary Outcome [ Time Frame: end of each treatment period (two months) ]
    Brain Pain inventory

  5. Short-Form Health Survey (SF-36) [ Time Frame: end of each treatment period (two months) ]
    minimum score 0 - more disability; maximum score 100 - less disability

  6. Myotonia Behaviour Score [ Time Frame: end of each treatment period (two months) ]
    minimum score 0 - minimum stiffness; maximum score 5 - incapacitating stiffness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults (≥ 18years),
  • genetically confirmed non-dystrophic myotonia (NDM),
  • presence of symptomatic myotonia as reported by the participant.

Exclusion Criteria:

  • concomitant medical conditions that would preclude the use of mexiletine or lamotrigine,
  • evidence of severe kidney disease or severe liver impairment [estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation <60ml/min/1.73m2],
  • pregnant or breastfeeding women,
  • participation in other treatment studies <30days before enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017155


Contacts
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Contact: Vinojini Vivekanandam, Dr 02031087182 v.vivekanandam@ucl.ac.uk
Contact: Iwona Skorupinska, Nurse 020 3108 7515 iwona.skorupinska@nhs.net

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom, WC1N 3BG
Contact: Vinojini Vivekanandam, Dr       v.vivekanandam@ucl.ac.uk   
Contact: Iwona Skorupinska, Nurse    020 3108 7515    iwona.skorupinska@nhs.net   
Sponsors and Collaborators
University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT05017155    
Other Study ID Numbers: 18/0582
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Request for sharing anonymised data can be made to the Chief Investigator (CI) for discussion/consideration.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Mexiletine
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers