Trial Outcomes & Findings for Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS) (NCT NCT01849770)
NCT ID: NCT01849770
Last Updated: 2021-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
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.
Results posted on
2021-09-29
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.).
Seventy-five (75) subjects signed the consent form and were considered enrolled in the study. Fifteen (15) subjects did not meet eligibility criteria and were considered screen failures. Sixty (60) subjects were randomized to one of three treatment arms. One (1) subject was randomized to the 900mg group but never started study drug.
Participant milestones
| Measure |
Mexiletine, 300 Milligrams
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
20
|
|
Overall Study
COMPLETED
|
20
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)
Baseline characteristics by cohort
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
58.0 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 7.0 • n=27 Participants
|
58.0 years
STANDARD_DEVIATION 8.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 participants
n=93 Participants
|
19 participants
n=4 Participants
|
20 participants
n=27 Participants
|
58 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
19 participants
n=4 Participants
|
20 participants
n=27 Participants
|
59 participants
n=483 Participants
|
|
Months Since Symptom Onset
|
21.0 Months
STANDARD_DEVIATION 10.3 • n=93 Participants
|
18.6 Months
STANDARD_DEVIATION 9.2 • n=4 Participants
|
17.5 Months
STANDARD_DEVIATION 8.3 • n=27 Participants
|
19.0 Months
STANDARD_DEVIATION 9.3 • n=483 Participants
|
|
Months Since Diagnosis
|
8.6 Months
STANDARD_DEVIATION 7.7 • n=93 Participants
|
8.9 Months
STANDARD_DEVIATION 8.2 • n=4 Participants
|
7.3 Months
STANDARD_DEVIATION 5.9 • n=27 Participants
|
8.3 Months
STANDARD_DEVIATION 7.2 • n=483 Participants
|
|
Slow Vital Capacity (Max % predicted)
|
86.7 Max %-predicted
STANDARD_DEVIATION 19.1 • n=93 Participants
|
86.2 Max %-predicted
STANDARD_DEVIATION 23.7 • n=4 Participants
|
83.7 Max %-predicted
STANDARD_DEVIATION 22.6 • n=27 Participants
|
85.6 Max %-predicted
STANDARD_DEVIATION 21.5 • n=483 Participants
|
|
Body Mass Index (BMI) (kg/m^2)
|
28.1 kilograms (kg)/meter squared (m^2)
STANDARD_DEVIATION 5.1 • n=93 Participants
|
27.3 kilograms (kg)/meter squared (m^2)
STANDARD_DEVIATION 4.1 • n=4 Participants
|
27.1 kilograms (kg)/meter squared (m^2)
STANDARD_DEVIATION 3.3 • n=27 Participants
|
27.5 kilograms (kg)/meter squared (m^2)
STANDARD_DEVIATION 4.2 • n=483 Participants
|
|
Baseline Cramps in Previous 24 hours
|
1.97 Number of Cramps
STANDARD_DEVIATION 3.06 • n=93 Participants
|
1.68 Number of Cramps
STANDARD_DEVIATION 1.63 • n=4 Participants
|
2.15 Number of Cramps
STANDARD_DEVIATION 2.13 • n=27 Participants
|
1.94 Number of Cramps
STANDARD_DEVIATION 2.31 • n=483 Participants
|
|
Baseline Cramps in Previous 30 Days
|
52.9 Number of Cramps
STANDARD_DEVIATION 91.0 • n=93 Participants
|
29.1 Number of Cramps
STANDARD_DEVIATION 43.9 • n=4 Participants
|
46.2 Number of Cramps
STANDARD_DEVIATION 55.9 • n=27 Participants
|
42.8 Number of Cramps
STANDARD_DEVIATION 66.1 • n=483 Participants
|
|
Maximum Cramp Pain in Previous 24 hours
|
1.75 units on a scale
STANDARD_DEVIATION 2.24 • n=93 Participants
|
2.32 units on a scale
STANDARD_DEVIATION 2.11 • n=4 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 2.78 • n=27 Participants
|
2.20 units on a scale
STANDARD_DEVIATION 2.38 • n=483 Participants
|
|
Maximum Cramp Pain in Previous 30 Days
|
3.00 units on a scale
STANDARD_DEVIATION 2.38 • n=93 Participants
|
3.37 units on a scale
STANDARD_DEVIATION 2.36 • n=4 Participants
|
3.35 units on a scale
STANDARD_DEVIATION 2.70 • n=27 Participants
|
3.24 units on a scale
STANDARD_DEVIATION 2.45 • n=483 Participants
|
|
ALSFRS-R Total Score
|
36.3 units on a scale
STANDARD_DEVIATION 7.8 • n=93 Participants
|
33.6 units on a scale
STANDARD_DEVIATION 6.7 • n=4 Participants
|
34.9 units on a scale
STANDARD_DEVIATION 5.5 • n=27 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 6.7 • n=483 Participants
|
PRIMARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Percentage of Participants That Discontinued Study Drug
|
5 percentage of participants
|
32 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Trough Plasma Concentration (Cmin) of Mexiletine
|
0.23 pg/mL
Standard Deviation 0.15
|
0.68 pg/mL
Standard Deviation 0.38
|
0 pg/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Mexiletine
|
0.41 pg/mL
Standard Deviation 0.19
|
1.27 pg/mL
Standard Deviation 0.67
|
0 pg/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 6 Visit (up to 6 hours post dose)Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.
|
2.34 µg*hr/mL
Standard Deviation 1.08
|
6.24 µg*hr/mL
Standard Deviation 3.18
|
0 µg*hr/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 6 Visit (up to 6 hours post dose)The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF)/Plasma Ratio
|
0.38 ratio
Standard Deviation 0.15
|
0.46 ratio
Standard Deviation 0.20
|
0 ratio
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 3-12, post titration of study medicationOutcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Mean Weekly Cramp Frequency
All Subjects n=20,19,20
|
0.785 cramps/week
Interval 0.304 to 2.023
|
0.231 cramps/week
Interval 0.125 to 1.25
|
2.505 cramps/week
Interval 1.03 to 6.092
|
|
Mean Weekly Cramp Frequency
10+cramps previous 30 days at Baseline n=20,19,20
|
1.898 cramps/week
Interval 0.494 to 7.288
|
0.595 cramps/week
Interval 0.112 to 3.153
|
8.563 cramps/week
Interval 3.217 to 22.79
|
SECONDARY outcome
Timeframe: Weeks 3-12, post titration of study medicationAt 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.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Maximal Pain Severity
All Subjects n=20,19,20
|
0.738 units on a scale
Interval 0.364 to 1.494
|
0.340 units on a scale
Interval 0.117 to 0.986
|
0.939 units on a scale
Interval 0.466 to 1.893
|
|
Maximal Pain Severity
10+cramps previous 30 days at Baseline n=20,19,20
|
1.348 units on a scale
Interval 0.616 to 2.953
|
0.572 units on a scale
Interval 0.176 to 1.859
|
2.033 units on a scale
Interval 1.123 to 3.681
|
SECONDARY outcome
Timeframe: Week 3-12, post titration of study medicationOutcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12
All Subjects n=20,19
|
0.313 ratio
Interval 0.1 to 0.982
|
0.158 ratio
Interval 0.05 to 0.495
|
—
|
|
Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12
10+cramps previous 30 days at Baseline n=20,19
|
0.222 ratio
Interval 0.079 to 0.624
|
0.069 ratio
Interval 0.013 to 0.374
|
—
|
SECONDARY outcome
Timeframe: Week 3-12, post titration of study medicationOutcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
10+cramps previous 30 days at Baseline n=20,19
|
0.663 ratio
Interval 0.347 to 1.267
|
0.281 ratio
Interval 0.08 to 0.992
|
—
|
|
Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
All Subjects n=20,19
|
0.785 ratio
Interval 0.342 to 1.802
|
0.361 ratio
Interval 0.131 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 3-12, post titration of study medicationAt 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.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Mean Pain Severity
All Subjects n=20,19,20
|
0.241 units on a scale
Interval 0.115 to 0.509
|
0.136 units on a scale
Interval 0.049 to 0.379
|
0.536 units on a scale
Interval 0.275 to 1.046
|
|
Mean Pain Severity
10+cramps previous 30 days at Baseline n=20,19,20
|
0.467 units on a scale
Interval 0.145 to 1.504
|
0.201 units on a scale
Interval 0.05 to 0.812
|
1.248 units on a scale
Interval 0.527 to 2.958
|
SECONDARY outcome
Timeframe: Week 3-12, post titration of study medicationOutcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
All Subjects n=20,19
|
0.450 ratio
Interval 0.183 to 1.11
|
0.254 ratio
Interval 0.098 to 0.658
|
—
|
|
Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
10+cramps previous 30 days at Baseline n=20,19
|
0.374 ratio
Interval 0.135 to 1.035
|
0.161 ratio
Interval 0.032 to 0.795
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16The 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.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Week 0 n=20,19,20
|
35.21 scores on a scale
Interval 32.9 to 37.5
|
35.21 scores on a scale
Interval 32.9 to 37.5
|
35.21 scores on a scale
Interval 32.9 to 37.5
|
|
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Week 2 n=20,19,20
|
35.14 scores on a scale
Interval 32.7 to 37.6
|
34.58 scores on a scale
Interval 32.0 to 37.1
|
35.47 scores on a scale
Interval 33.0 to 37.9
|
|
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Week 6 n=20,19,20
|
35.72 scores on a scale
Interval 33.1 to 38.3
|
33.08 scores on a scale
Interval 30.4 to 35.8
|
34.25 scores on a scale
Interval 31.7 to 36.8
|
|
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Week 12 n=20,19,20
|
33.33 scores on a scale
Interval 30.4 to 36.3
|
31.85 scores on a scale
Interval 28.6 to 35.1
|
33.48 scores on a scale
Interval 30.5 to 36.4
|
|
Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Week 16 n=20,19,20
|
32.44 scores on a scale
Interval 29.2 to 35.7
|
31.94 scores on a scale
Interval 28.2 to 35.6
|
32.96 scores on a scale
Interval 29.7 to 36.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 6, and Week 12 (or Early Termination Date)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.
Outcome measures
| Measure |
Mexiletine, 300 Milligrams
n=20 Participants
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 Participants
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 Participants
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Change in Slow Vital Capacity (SVC) Score
Week 0 n=20,19,20
|
87.74 percent of predicted normal
Interval 80.0 to 95.5
|
87.74 percent of predicted normal
Interval 80.0 to 95.5
|
87.74 percent of predicted normal
Interval 80.0 to 95.5
|
|
Change in Slow Vital Capacity (SVC) Score
Week 6 n=20,19,20
|
86.51 percent of predicted normal
Interval 78.1 to 94.9
|
82.92 percent of predicted normal
Interval 73.9 to 91.9
|
84.79 percent of predicted normal
Interval 76.3 to 93.3
|
|
Change in Slow Vital Capacity (SVC) Score
Week 12 n=20,19,20
|
83.98 percent of predicted normal
Interval 75.1 to 92.8
|
77.18 percent of predicted normal
Interval 67.0 to 87.4
|
79.58 percent of predicted normal
Interval 70.7 to 88.4
|
Adverse Events
Mexiletine, 300 Milligrams
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Mexiletine, 900 Milligrams
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mexiletine, 300 Milligrams
n=20 participants at risk
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 participants at risk
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 participants at risk
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Mexiletine, 300 Milligrams
n=20 participants at risk
Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Mexiletine, 900 Milligrams
n=19 participants at risk
Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine
|
Placebo
n=20 participants at risk
Placebo, by mouth per day for 12 weeks.
Placebo
|
|---|---|---|---|
|
General disorders
Gait Disturbance
|
5.0%
1/20 • Number of events 2
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
5.0%
1/20 • Number of events 2
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Cystitis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Ear Infection
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Herpes Zoster
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Infections and infestations
Influenza
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
2/20 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
5.0%
1/20 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20
|
0.00%
0/19
|
15.0%
3/20 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Eructation
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/20
|
5.3%
1/19 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
42.1%
8/19 • Number of events 15
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1
|
10.5%
2/19 • Number of events 6
|
0.00%
0/20
|
|
General disorders
Asthenia
|
5.0%
1/20 • Number of events 1
|
15.8%
3/19 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Chest Discomfort
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 4
|
21.1%
4/19 • Number of events 7
|
15.0%
3/20 • Number of events 3
|
|
General disorders
Feeling Jittery
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
2/20 • Number of events 3
|
0.00%
0/19
|
5.0%
1/20 • Number of events 2
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
5.0%
1/20 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Number of events 2
|
26.3%
5/19 • Number of events 6
|
20.0%
4/20 • Number of events 7
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
10.0%
2/20 • Number of events 2
|
26.3%
5/19 • Number of events 5
|
10.0%
2/20 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.0%
1/20 • Number of events 1
|
21.1%
4/19 • Number of events 5
|
10.0%
2/20 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Investigations
Blood Potassium Decreased
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood Pressure Diastolic Decreased
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Urine Analysis Abnormal
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Urine Output Increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Investigations
Weight Decreased
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20
|
0.00%
0/19
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Number of events 2
|
0.00%
0/19
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
1/20 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
10.0%
2/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
15.0%
3/20 • Number of events 5
|
15.8%
3/19 • Number of events 3
|
15.0%
3/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
10.0%
2/20 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
5.0%
1/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/20
|
15.8%
3/19 • Number of events 3
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Sensation of Heaviness
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Crying
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Number of events 4
|
31.6%
6/19 • Number of events 7
|
20.0%
4/20 • Number of events 4
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2
|
21.1%
4/19 • Number of events 6
|
10.0%
2/20 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20
|
0.00%
0/19
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/20
|
26.3%
5/19 • Number of events 7
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/20
|
15.8%
3/19 • Number of events 3
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
0.00%
0/20
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
10.5%
2/19 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
Psychiatric disorders
Euphoric Mood
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Nervousness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Chromaturia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
15.0%
3/20 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
|
Surgical and medical procedures
Epidural Blood Patch
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Surgical and medical procedures
Surgical Stapling
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Flushing
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Haematoma
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/20
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place