None listed
Conditions
Brief summary
Treatment strategies for motor neuron disease are limited. The investigators hope to show that a sodium channel blocking agent slows progression in this devastating disease.
Interventions
Patients will only receive flecainide during the 32-week treatment phase; not during the initial 12-week lead-in phase. Patients will not receive anything in addition to their pre-existing medications during the lead-in phase.
Flecainide will be taken 50mg twice per day in the first week of the 32-week treatment phase, and 100mg twice per day thereafter. Patients will receive flecainide for 32 weeks. Oral mode of administration.
Sponsors
South Eastern Sydney Illawarra Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of "definite" or "probable" amyotrophic lateral sclerosis according to the revised El Escorial criteria (as defined by the Committee on Neuromuscular 2. Diagnosis of "possible" amyotrophic lateral sclerosis according to the revised El Escorial criteria plus abnormally reduced short intracortical inhibition on transcranial magnetic stimulation. 3. Disease duration of less than five years. 4. Sniff nasal inspiratory pressure of greater than 50% predicted. 5. Normal cardiac rhythm (as determined by electrocardiograph) and left ventricular function (assessed by echocardiography). 6. Ability to provide consent.
Exclusion criteria
1. History of dementia or major psychiatric disorder. 2. Involvement in other clinical trials 3. Pregnancy or lactation 4. History of cardiac disease. 5. Significant impairment of hepatic and/or renal function. 6. Any patient considered to be non compliant.
Outcome results
None listed