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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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12 December 2020 |
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Main ID: |
NCT02781454 |
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Date of registration:
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10/05/2016 |
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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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Mexiletine in Sporadic Amyotrophic Lateral Sclerosis
Mexiletine-2 |
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Scientific title:
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Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS) |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02781454 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Weiss, 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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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or
definite ALS as defined by revised El Escorial criteria.
2. Age 18 years or older.
3. Symptom onset of weakness or spasticity due to ALS = 60 months prior to Screening
Visit.
4. Slow vital capacity (SVC) measure =50% of predicted for gender, height, and age at the
screening visit.
5. Must be able to swallow capsules throughout the course of the study, according to Site
Investigator judgment.
6. Capable of providing informed consent and following trial procedures.
7. For TMS: a resting motor threshold defined as 50% of pulses eliciting a motor evoked
potential (MEP) of amplitude = 50 µV.
8. For TTNCS: median Compound Muscle Action Potential (CMAP) = 1.5 mV.
9. Subjects must not have taken riluzole for at least 30 days or be on a stable dose of
riluzole for at least 30 days prior to the Screening Visit and continue on the stable
dose throughout the course of the study (riluzole-naïve subjects are permitted in the
study).
10. Subjects must not have taken medication for muscle cramping such as cyclobenzaprine,
baclofen, carisoprodol, or methocarbamol, for at least 30 days prior to screening or
be on a stable dose for at least 60 days prior to screening.
11. Geographic accessibility to the site.
12. Women must not become pregnant for the duration of the study and must be willing to
use two contraceptive therapies and have a negative pregnancy test throughout the
course of the study.
13. Use of medications known to affect the neurophysiology measures in the study must be
scheduled, not as needed (pro re nata, PRN). A subject must have been on a fixed dose
for 30 days prior to the Screening Visit, and there must be no reason to believe that
a subsequent change would be necessary during the course of the study. These
medications include: benzodiazepines, muscle relaxants, tricyclic antidepressants,
selective serotonin reuptake inhibitors, non-selective serotonin reuptake inhibitors,
hypnotics (including anti-histamines) and anti-cholinergics.
Exclusion Criteria:
1. Invasive ventilator dependence, such as tracheostomy.
2. Creatinine level greater than 1.5 mg/dL at screening.
3. Serum Glutamic-Oxaloacetic (SGOT/AST) / Serum Glutamic-Pyruvic (SGPT/ALT) greater than
3 times the upper limit of normal at screening.
4. History of known sensitivity or intolerability to mexiletine or lidocaine.
5. Any history of either substance abuse within the past year, unstable psychiatric
disease, cognitive impairment, or dementia.
6. Clinically significant conduction abnormalities on electrocardiogram or a known
history of cardiac arrhythmia.
7. Known history of epilepsy.
8. Known history of congestive heart failure (CHF) or history of myocardial infarction
within the past 24 months.
9. Use of mexiletine for 30 days prior to Screening Visit.
10. Exposure to any other experimental agent (off-label use or investigational) including
high dose creatine (>10 grams a day) within 30 days prior to Screening Visit.
11. Metal in the head and neck region, cardiac pacemaker or brain stimulator, cochlear
implants, implanted infusion device or personal history of epilepsy.
12. Use of amiodarone, flecainide, duloxetine, tizanidine, or clozapine.
13. Pregnant women or women currently breastfeeding.
14. Placement of Diaphragm Pacing System (DPS) device < 60 days prior to Screening Visit.
15. Planned DPS device implantation during study participation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sporadic Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: Mexiletine
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Primary Outcome(s)
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Change in Resting Motor Threshold
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported]
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Secondary Outcome(s)
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Effect on Cortical Silent Period
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Frequency of Fasciculations (Muscle Twitching)
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported]
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Effect on Hyperpolarizing Threshold Electrotonus (90-100 ms)
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Strength Duration Time Constant
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Depolarizing Threshold Electrotonus (90-100 ms)
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Change in Motor Evoked Potential Amplitude
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Superexcitability
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Frequency of Muscle Cramps
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported]
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Effect on Short-interval Intracortical Inhibition
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Effect on Subexcitability
[Time Frame: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported]
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Secondary ID(s)
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MX-ALS-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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