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CompletedNCT01849770MX-ALS-001Updated Sep 29, 2021Results posted

Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)

A Phase 2 interventional study of Mexiletine and Placebo in Sporadic Amyotrophic Lateral Sclerosis, sponsored by University of Washington. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research is to find out if mexiletine is safe and effective in people with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either 300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo (non-active study drug). The safety and efficacy of these doses will be compared to see if one dose is better than the other.

Read the detailed description

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. Mexiletine is a use-dependent sodium channel blocker that has been FDA-approved for decades for the treatment of cardiac arrhythmias and more recently to treat neuropathic pain in diabetic polyneuropathy. Mexiletine has been shown also to be protective of neurons following spinal cord, head injury, and cerebral ischemia, largely by blocking excitotoxicity. Based on previous studies, mexiletine appears to penetrate into the central nervous system at concentrations sufficient to confer significant protection. Recent unpublished studies in the laboratory of Dr. Robert Brown at the University of Massachusetts have also demonstrated that mexiletine ingestion in mice genetically engineered to express high levels of mutant cytosolic copper-zinc superoxide dismutase-1 (SOD1) transgene prolongs survival in these animals. As mexiletine already has FDA-approval as an anti-arrhythmic agent, much is known about the pharmacology and safety of this drug in non-ALS patients. We anticipate that by excluding subjects with a known history of cardiac disease and with the known neuroprotectant properties of this medication, mexiletine is a good choice for further study in an ALS clinical trial.

02

Conditions studied

  • Sporadic Amyotrophic Lateral Sclerosis

Keywords

  • SALS
  • Mexiletine
  • Safety
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 75 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Sporadic Amyotrophic Lateral Sclerosis (SALS) diagnosed as possible, laboratory-supported probable, probable, or definite ALS as defined by revised El Escorial criteria.
  • Age 18 years or older.
  • Disease duration ≤ 36 months from ALS symptom onset.
  • Capable of providing informed consent and following trial procedures.
  • Subjects must not have taken riluzole for at least 30 days or be on a 50 milligrams twice daily dose of riluzole for at least 60 days prior to randomization (riluzole-naïve subjects are permitted in the study).
  • Subjects must not have taken medication for muscle cramping such as cyclobenzaprine, baclofen, carisoprodol, or methocarbamol, for at least 30 days prior to randomization or be on a stable dose for at least 60 days prior to randomization.
  • Geographic accessibility to the site.
  • 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.
  • Slow vital capacity (SVC) measure greater than or equal to 50% of predicted for gender, height, and age at the screening visit.
  • Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (for example, no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).
  • Must be able to swallow capsules throughout the course of the study, according to Principal Investigator (PI) judgment.
  • Must have a caregiver assist with dispensing the study drug.

Exclusion criteria

Exclusion Criteria:

  • Invasive ventilator dependence, such as tracheostomy.
  • Creatinine level greater than 1.5 milligram/deciliter.
  • Serum glutamic oxaloacetic transaminase or (aspartate transaminase) / serum glutamic pyruvic transaminase (alanine aminotransferase) greater than 3 times the upper limit of normal at screening.
  • History of known sensitivity or intolerability to mexiletine or lidocaine.
  • Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia.
  • Clinically significant conduction abnormalities on electrocardiogram or a known history of cardiac arrhythmia.
  • Known history of epilepsy.
  • Known history of congestive heart failure (CHF) or history of myocardial infarction within the past 24 months.
  • Use of mexiletine for 60 days prior to Baseline Visit.
  • Exposure to any other experimental agent (off-label use or investigational) including high dose creatine (greater than 10 grams a day) within 30 days prior to Baseline Visit.
  • Use of amiodarone, flecainide, duloxetine, tizanidine, or clozapine.
  • Pregnant women or women currently breastfeeding.
  • Placement of Diaphragm Pacing System (DPS) device less than 60 days prior to Baseline Visit.
  • Planned DPS device implantation after Baseline Visit.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    Mexiletine, 300 milligrams

    Mexiletine, 300 milligrams by mouth per day for 12 weeks.

    Drug: Mexiletine

  • Active comparator
    Mexiletine, 900 milligrams

    Mexiletine, 900 milligrams by mouth per day for 12 weeks.

    Drug: Mexiletine

  • Placebo comparator
    Placebo

    Placebo, by mouth per day for 12 weeks.

    Drug: Placebo

Interventions

  • DrugMexiletine

    Also known as: Mexitil

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Percentage of Participants That Discontinued Study Drug

    Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.

    Time frame: Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.

Secondary outcomes

  1. Trough Plasma Concentration (Cmin) of Mexiletine

    Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

    Time frame: Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)

  2. Peak Plasma Concentration (Cmax) of Mexiletine

    Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

    Time frame: Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)

  3. Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.

    Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

    Time frame: Week 6 Visit (up to 6 hours post dose)

  4. Mean Cerebrospinal Fluid (CSF)/Plasma Ratio

    The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.

    Time frame: Week 6 Visit (up to 6 hours post dose)

  5. Mean Weekly Cramp Frequency

    Time frame: Week 3-12, post titration of study medication

  6. Maximal Pain Severity

    At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily.

    Time frame: Weeks 3-12, post titration of study medication

  7. Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12

    Time frame: Week 3-12, post titration of study medication

  8. Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12

    Time frame: Week 3-12, post titration of study medication

  9. Mean Pain Severity

    At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily.

    Time frame: Weeks 3-12, post titration of study medication

  10. Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12

    Time frame: Week 3-12, post titration of study medication

Other outcomes

  1. Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score

    The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.

    Time frame: Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16

  2. Change in Slow Vital Capacity (SVC) Score

    The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.

    Time frame: Week 0, Week 6, and Week 12 (or Early Termination Date)

07

Results

Posted Oct 12, 2015

Participant flow

The first subject in the study was enrolled July 23, 2013. Subjects were recruited and seen at Amyotrophic Lateral Sclerosis (ALS) clinics at 10 sites across the United States (U.S.).

Participant flow — Overall Study
MilestoneMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Started201920
Completed201519
Not completed041

Outcome measures

PrimaryPercentage of Participants That Discontinued Study Drug

Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.

Time frame:
Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.
Reported as:
Number · percentage of participants
Percentage of Participants That Discontinued Study Drug
percentage of participantsMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Percentage of Participants That Discontinued Study Drug5325
SecondaryTrough Plasma Concentration (Cmin) of Mexiletine

Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

Time frame:
Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)
Reported as:
Mean · pg/mL
Trough Plasma Concentration (Cmin) of Mexiletine
pg/mLMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Trough Plasma Concentration (Cmin) of Mexiletine0.23 ± 0.150.68 ± 0.380 ± 0
SecondaryPeak Plasma Concentration (Cmax) of Mexiletine

Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

Time frame:
Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)
Reported as:
Mean · pg/mL
Peak Plasma Concentration (Cmax) of Mexiletine
pg/mLMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Peak Plasma Concentration (Cmax) of Mexiletine0.41 ± 0.191.27 ± 0.670 ± 0
SecondaryArea Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.

Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.

Time frame:
Week 6 Visit (up to 6 hours post dose)
Reported as:
Mean · µg*hr/mL
Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.
µg*hr/mLMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.2.34 ± 1.086.24 ± 3.180 ± 0
SecondaryMean Cerebrospinal Fluid (CSF)/Plasma Ratio

The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.

Time frame:
Week 6 Visit (up to 6 hours post dose)
Reported as:
Mean · ratio
Mean Cerebrospinal Fluid (CSF)/Plasma Ratio
ratioMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Mean Cerebrospinal Fluid (CSF)/Plasma Ratio0.38 ± 0.150.46 ± 0.200 ± 0
SecondaryMean Weekly Cramp Frequency
Time frame:
Week 3-12, post titration of study medication
Reported as:
Mean · cramps/week
Mean Weekly Cramp Frequency
cramps/weekMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
All Subjects n=20,19,200.785 (0.304 to 2.023)0.231 (0.125 to 1.250)2.505 (1.030 to 6.092)
10+cramps previous 30 days at Baseline n=20,19,201.898 (0.494 to 7.288)0.595 (0.112 to 3.153)8.563 (3.217 to 22.79)
Other pre-specifiedChange in ALS Functional Rating Scale- Revised (ALSFRS-R) Score

The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.

Time frame:
Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16
Reported as:
Mean · scores on a scale
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
scores on a scaleMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Week 0 n=20,19,2035.21 (32.9 to 37.5)35.21 (32.9 to 37.5)35.21 (32.9 to 37.5)
Week 2 n=20,19,2035.14 (32.7 to 37.6)34.58 (32.0 to 37.1)35.47 (33.0 to 37.9)
Week 6 n=20,19,2035.72 (33.1 to 38.3)33.08 (30.4 to 35.8)34.25 (31.7 to 36.8)
Week 12 n=20,19,2033.33 (30.4 to 36.3)31.85 (28.6 to 35.1)33.48 (30.5 to 36.4)
Week 16 n=20,19,2032.44 (29.2 to 35.7)31.94 (28.2 to 35.6)32.96 (29.7 to 36.2)
Statistical analysis
  • Mexiletine, 300 Milligrams vs Placebo · Random slopes model · p = 0.561 · Slope: -0.23 · 95% CI -1.03 to 0.56
  • Mexiletine, 900 Milligrams vs Placebo · Random slopes model · p = 0.662 · Slope: -0.19 · 95% CI -1.04 to 0.66
Other pre-specifiedChange in Slow Vital Capacity (SVC) Score

The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.

Time frame:
Week 0, Week 6, and Week 12 (or Early Termination Date)
Reported as:
Mean · percent of predicted normal
Change in Slow Vital Capacity (SVC) Score
percent of predicted normalMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Week 0 n=20,19,2087.74 (80.0 to 95.5)87.74 (80.0 to 95.5)87.74 (80.0 to 95.5)
Week 6 n=20,19,2086.51 (78.1 to 94.9)82.92 (73.9 to 91.9)84.79 (76.3 to 93.3)
Week 12 n=20,19,2083.98 (75.1 to 92.8)77.18 (67.0 to 87.4)79.58 (70.7 to 88.4)
Statistical analysis
  • Mexiletine, 300 Milligrams vs Placebo · Random slopes model · p = 0.178 · Slope: 1.71 · 95% CI -0.80 to 4.22
  • Mexiletine, 900 Milligrams vs Placebo · Random slopes model · p = 0.510 · Slope: -0.94 · 95% CI -3.80 to 1.91
SecondaryMaximal Pain Severity

At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily.

Time frame:
Weeks 3-12, post titration of study medication
Reported as:
Mean · units on a scale
Maximal Pain Severity
units on a scaleMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
All Subjects n=20,19,200.738 (0.364 to 1.494)0.340 (0.117 to 0.986)0.939 (0.466 to 1.893)
10+cramps previous 30 days at Baseline n=20,19,201.348 (0.616 to 2.953)0.572 (0.176 to 1.859)2.033 (1.123 to 3.681)
SecondaryCramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12
Time frame:
Week 3-12, post titration of study medication
Reported as:
Number · ratio
Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12
ratio300mg vs Placebo900mg vs Placebo
All Subjects n=20,190.313 (0.100 to 0.982)0.158 (0.050 to 0.495)
10+cramps previous 30 days at Baseline n=20,190.222 (0.079 to 0.624)0.069 (0.013 to 0.374)
SecondaryMaximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
Time frame:
Week 3-12, post titration of study medication
Reported as:
Number · ratio
Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
ratio300mg vs Placebo900mg vs Placebo
All Subjects n=20,190.785 (0.342 to 1.802)0.361 (0.131 to 1.000)
10+cramps previous 30 days at Baseline n=20,190.663 (0.347 to 1.267)0.281 (0.080 to 0.992)
SecondaryMean Pain Severity

At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily.

Time frame:
Weeks 3-12, post titration of study medication
Reported as:
Mean · units on a scale
Mean Pain Severity
units on a scaleMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
All Subjects n=20,19,200.241 (0.115 to 0.509)0.136 (0.049 to 0.379)0.536 (0.275 to 1.046)
10+cramps previous 30 days at Baseline n=20,19,200.467 (0.145 to 1.504)0.201 (0.050 to 0.812)1.248 (0.527 to 2.958)
SecondaryMean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
Time frame:
Week 3-12, post titration of study medication
Reported as:
Number · ratio
Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
ratio300mg vs Placebo900mg vs Placebo
All Subjects n=20,190.450 (0.183 to 1.110)0.254 (0.098 to 0.658)
10+cramps previous 30 days at Baseline n=20,190.374 (0.135 to 1.035)0.161 (0.032 to 0.795)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mexiletine, 300 Milligrams—0/20 (0%)17/20 (85%)
Mexiletine, 900 Milligrams—1/19 (5.3%)19/19 (100%)
Placebo—2/20 (10%)18/20 (90%)
Most frequent serious events
Most frequent serious events
EventMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
Balance DisorderNervous system disorders0/201/190/20
Lower Limb FractureInjury, poisoning and procedural complications0/200/191/20
DyspnoeaRespiratory, thoracic and mediastinal disorders0/200/191/20
Respiratory FailureRespiratory, thoracic and mediastinal disorders0/200/191/20
Most frequent other events
Showing 10 of 99
Most frequent other events
EventMexiletine, 300 MilligramsMexiletine, 900 MilligramsPlacebo
NauseaGastrointestinal disorders1/208/192/20
DizzinessNervous system disorders3/206/194/20
FallInjury, poisoning and procedural complications2/205/194/20
Post Lumbar Puncture SyndromeInjury, poisoning and procedural complications2/205/192/20
TremorNervous system disorders0/205/191/20
ConstipationGastrointestinal disorders1/204/192/20
FatigueGeneral disorders2/204/193/20
Procedural PainInjury, poisoning and procedural complications1/204/192/20
HeadacheNervous system disorders2/204/192/20
AstheniaGeneral disorders1/203/192/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Mean59.2 ± 7.158.0 ± 10.757.0 ± 7.058.0 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Female671023
Male14121036
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Asian1001
Caucasian19192058
Region of Enrollment
Region of Enrollment(participants)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
United States20192059
Months Since Symptom Onset
Months Since Symptom Onset(Months)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Mean21.0 ± 10.318.6 ± 9.217.5 ± 8.319.0 ± 9.3
Months Since Diagnosis
Months Since Diagnosis(Months)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Mean8.6 ± 7.78.9 ± 8.27.3 ± 5.98.3 ± 7.2
Slow Vital Capacity (Max % predicted)
Slow Vital Capacity (Max % predicted)(Max %-predicted)Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Mean86.7 ± 19.186.2 ± 23.783.7 ± 22.685.6 ± 21.5
Body Mass Index (BMI) (kg/m^2)
Body Mass Index (BMI) (kg/m^2)(kilograms (kg)/meter squared (m^2))Mexiletine, 300 MilligramsMexiletine, 900 MilligramsPlaceboTotal
Mean28.1 ± 5.127.3 ± 4.127.1 ± 3.327.5 ± 4.2

5 further baseline measures are reported on the registry.

08

Study locations

10 sites
  • UCLA, Neuromuscular Research Center
    Los Angeles, California 90095, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Massachusetts (Worcester) Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • Washington University Medical School
    Saint Louis, Missouri 63110, United States
  • SUNY Upstate Medical Center
    Syracuse, New York 13210, United States
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • University of Texas Southwestern Medical Center at Dallas
    Dallas, Texas 75390-8897, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01849770
Lead sponsor
University of Washington
Responsible party
Michael D Weiss (Associate Professor, Department of Neurology, University of Washington) — Principal investigator
First posted
May 8, 2013
Start date
Jul 2013
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Oct 12, 2015
Last update
Sep 29, 2021

Study contacts

Michael D Weiss, MD
principal investigator · University of Washington Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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