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Trial record 3 of 21 for:    mexiletine

Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS) (MX-ALS-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849770
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Michael D Weiss, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sporadic Amyotrophic Lateral Sclerosis
Interventions Drug: Mexiletine
Drug: Placebo
Enrollment 75
Recruitment Details 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.).
Pre-assignment Details 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.
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Period Title: Overall Study
Started 20 19 20
Completed 20 15 19
Not Completed 0 4 1
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo Total
Hide Arm/Group Description

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 20 19 20 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 20 participants 59 participants
59.2  (7.1) 58.0  (10.7) 57.0  (7.0) 58.0  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 20 participants 59 participants
Female
6
  30.0%
7
  36.8%
10
  50.0%
23
  39.0%
Male
14
  70.0%
12
  63.2%
10
  50.0%
36
  61.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 20 participants 59 participants
Asian 1 0 0 1
Caucasian 19 19 20 58
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 20 participants 59 participants
20 19 20 59
Months Since Symptom Onset   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 20 participants 19 participants 20 participants 59 participants
21.0  (10.3) 18.6  (9.2) 17.5  (8.3) 19.0  (9.3)
[1]
Measure Description: Number of months since ALS symptom onset prior to enrolling into this study.
Months Since Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 20 participants 19 participants 20 participants 59 participants
8.6  (7.7) 8.9  (8.2) 7.3  (5.9) 8.3  (7.2)
[1]
Measure Description: Number of months since enrolling into the study that a subject was diagnosed with ALS.
Slow Vital Capacity (Max % predicted)  
Mean (Standard Deviation)
Unit of measure:  Max %-predicted
Number Analyzed 20 participants 19 participants 20 participants 59 participants
86.7  (19.1) 86.2  (23.7) 83.7  (22.6) 85.6  (21.5)
Body Mass Index (BMI) (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)/meter squared (m^2)
Number Analyzed 20 participants 19 participants 20 participants 59 participants
28.1  (5.1) 27.3  (4.1) 27.1  (3.3) 27.5  (4.2)
Baseline Cramps in Previous 24 hours  
Mean (Standard Deviation)
Unit of measure:  Number of Cramps
Number Analyzed 20 participants 19 participants 20 participants 59 participants
1.97  (3.06) 1.68  (1.63) 2.15  (2.13) 1.94  (2.31)
Baseline Cramps in Previous 30 Days  
Mean (Standard Deviation)
Unit of measure:  Number of Cramps
Number Analyzed 20 participants 19 participants 20 participants 59 participants
52.9  (91.0) 29.1  (43.9) 46.2  (55.9) 42.8  (66.1)
Maximum Cramp Pain in Previous 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 20 participants 59 participants
1.75  (2.24) 2.32  (2.11) 2.55  (2.78) 2.20  (2.38)
[1]
Measure Description: Cramp pain measured at 0 no pain and 10 is worst pain.
Maximum Cramp Pain in Previous 30 Days   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 20 participants 59 participants
3.00  (2.38) 3.37  (2.36) 3.35  (2.70) 3.24  (2.45)
[1]
Measure Description: Cramp pain measured at 0 no pain and 10 is worst pain.
ALSFRS-R Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 20 participants 59 participants
36.3  (7.8) 33.6  (6.7) 34.9  (5.5) 35.0  (6.7)
[1]
Measure Description: ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score at Baseline. Scale is measured from 0 (worst score) to 48 points (best score).
1.Primary Outcome
Title Percentage of Participants That Discontinued Study Drug
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Measure Type: Number
Unit of Measure: percentage of participants
5 32 5
2.Secondary Outcome
Title Trough Plasma Concentration (Cmin) of Mexiletine
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.23  (0.15) 0.68  (0.38) 0  (0)
3.Secondary Outcome
Title Peak Plasma Concentration (Cmax) of Mexiletine
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.41  (0.19) 1.27  (0.67) 0  (0)
4.Secondary Outcome
Title Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
2.34  (1.08) 6.24  (3.18) 0  (0)
5.Secondary Outcome
Title Mean Cerebrospinal Fluid (CSF)/Plasma Ratio
Hide Description The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.
Time Frame Week 6 Visit (up to 6 hours post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (Standard Deviation)
Unit of Measure: ratio
0.38  (0.15) 0.46  (0.20) 0  (0)
6.Secondary Outcome
Title Mean Weekly Cramp Frequency
Hide Description [Not Specified]
Time Frame Week 3-12, post titration of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (95% Confidence Interval)
Unit of Measure: cramps/week
All Subjects n=20,19,20
0.785
(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=20,19,20
1.898
(0.494 to 7.288)
0.595
(0.112 to 3.153)
8.563
(3.217 to 22.79)
7.Secondary Outcome
Title Maximal Pain Severity
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
All Subjects n=20,19,20
0.738
(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=20,19,20
1.348
(0.616 to 2.953)
0.572
(0.176 to 1.859)
2.033
(1.123 to 3.681)
8.Secondary Outcome
Title Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12
Hide Description [Not Specified]
Time Frame Week 3-12, post titration of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 300mg vs Placebo 900mg vs Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
All Subjects n=20,19
0.313
(0.100 to 0.982)
0.158
(0.050 to 0.495)
10+cramps previous 30 days at Baseline n=20,19
0.222
(0.079 to 0.624)
0.069
(0.013 to 0.374)
9.Secondary Outcome
Title Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
Hide Description [Not Specified]
Time Frame Week 3-12, post titration of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 300mg vs Placebo 900mg vs Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
All Subjects n=20,19
0.785
(0.342 to 1.802)
0.361
(0.131 to 1.000)
10+cramps previous 30 days at Baseline n=20,19
0.663
(0.347 to 1.267)
0.281
(0.080 to 0.992)
10.Secondary Outcome
Title Mean Pain Severity
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
All Subjects n=20,19,20
0.241
(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=20,19,20
0.467
(0.145 to 1.504)
0.201
(0.050 to 0.812)
1.248
(0.527 to 2.958)
11.Secondary Outcome
Title Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12
Hide Description [Not Specified]
Time Frame Week 3-12, post titration of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 300mg vs Placebo 900mg vs Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
All Subjects n=20,19
0.450
(0.183 to 1.110)
0.254
(0.098 to 0.658)
10+cramps previous 30 days at Baseline n=20,19
0.374
(0.135 to 1.035)
0.161
(0.032 to 0.795)
12.Other Pre-specified Outcome
Title Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
Week 0 n=20,19,20
35.21
(32.9 to 37.5)
35.21
(32.9 to 37.5)
35.21
(32.9 to 37.5)
Week 2 n=20,19,20
35.14
(32.7 to 37.6)
34.58
(32.0 to 37.1)
35.47
(33.0 to 37.9)
Week 6 n=20,19,20
35.72
(33.1 to 38.3)
33.08
(30.4 to 35.8)
34.25
(31.7 to 36.8)
Week 12 n=20,19,20
33.33
(30.4 to 36.3)
31.85
(28.6 to 35.1)
33.48
(30.5 to 36.4)
Week 16 n=20,19,20
32.44
(29.2 to 35.7)
31.94
(28.2 to 35.6)
32.96
(29.7 to 36.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mexiletine, 300 Milligrams, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method Random slopes model
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-1.03 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mexiletine, 900 Milligrams, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Random slopes model
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-1.04 to 0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change in Slow Vital Capacity (SVC) Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description:

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

Overall Number of Participants Analyzed 20 19 20
Mean (95% Confidence Interval)
Unit of Measure: percent of predicted normal
Week 0 n=20,19,20
87.74
(80.0 to 95.5)
87.74
(80.0 to 95.5)
87.74
(80.0 to 95.5)
Week 6 n=20,19,20
86.51
(78.1 to 94.9)
82.92
(73.9 to 91.9)
84.79
(76.3 to 93.3)
Week 12 n=20,19,20
83.98
(75.1 to 92.8)
77.18
(67.0 to 87.4)
79.58
(70.7 to 88.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mexiletine, 300 Milligrams, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments [Not Specified]
Method Random slopes model
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
-0.80 to 4.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mexiletine, 900 Milligrams, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method Random slopes model
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-3.80 to 1.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.42
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Hide Arm/Group Description

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

Mexiletine

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

Mexiletine

Placebo, by mouth per day for 12 weeks.

Placebo

All-Cause Mortality
Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/19 (5.26%)      2/20 (10.00%)    
Injury, poisoning and procedural complications       
Lower Limb Fracture *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders       
Balance Disorder *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Respiratory Failure *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mexiletine, 300 Milligrams Mexiletine, 900 Milligrams Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/20 (85.00%)      19/19 (100.00%)      18/20 (90.00%)    
Ear and labyrinth disorders       
Tinnitus *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal Discomfort *  1/20 (5.00%)  1 2/19 (10.53%)  2 0/20 (0.00%)  0
Abdominal Distension *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Abdominal Pain *  0/20 (0.00%)  0 0/19 (0.00%)  0 3/20 (15.00%)  4
Constipation *  1/20 (5.00%)  1 4/19 (21.05%)  4 2/20 (10.00%)  2
Dry Mouth *  1/20 (5.00%)  1 1/19 (5.26%)  1 1/20 (5.00%)  1
Dyspepsia *  1/20 (5.00%)  1 1/19 (5.26%)  1 3/20 (15.00%)  3
Dysphagia *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Eructation *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Gastroesophageal Reflux Disease *  0/20 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
Haemorrhoids *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Hypoaesthesia Oral *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Nausea *  1/20 (5.00%)  1 8/19 (42.11%)  15 2/20 (10.00%)  2
Salivary Hypersecretion *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Toothache *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Vomiting *  1/20 (5.00%)  1 2/19 (10.53%)  6 0/20 (0.00%)  0
General disorders       
Asthenia *  1/20 (5.00%)  1 3/19 (15.79%)  4 2/20 (10.00%)  2
Chest Discomfort *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Drug Withdrawal Syndrome *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Fatigue *  2/20 (10.00%)  4 4/19 (21.05%)  7 3/20 (15.00%)  3
Feeling Jittery *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Gait Disturbance *  1/20 (5.00%)  2 0/19 (0.00%)  0 1/20 (5.00%)  1
Oedema Peripheral *  1/20 (5.00%)  2 0/19 (0.00%)  0 1/20 (5.00%)  1
Pain *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Infections and infestations       
Cystitis *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Ear Infection *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Gastroenteritis *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Herpes Zoster *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Influenza *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Nasopharyngitis *  1/20 (5.00%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
Oral Herpes *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Upper Respiratory Tract Infection *  2/20 (10.00%)  2 1/19 (5.26%)  1 2/20 (10.00%)  2
Urinary Tract Infection *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications       
Contusion *  2/20 (10.00%)  3 0/19 (0.00%)  0 1/20 (5.00%)  2
Excoriation *  1/20 (5.00%)  1 0/19 (0.00%)  0 1/20 (5.00%)  2
Fall *  2/20 (10.00%)  2 5/19 (26.32%)  6 4/20 (20.00%)  7
Joint Sprain *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Lower Limb Fracture *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Post Lumbar Puncture Syndrome *  2/20 (10.00%)  2 5/19 (26.32%)  5 2/20 (10.00%)  2
Post Procedural Discomfort *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Procedural Nausea *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Procedural Pain *  1/20 (5.00%)  1 4/19 (21.05%)  5 2/20 (10.00%)  2
Skin Laceration *  0/20 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
Investigations       
Blood Glucose Increased *  0/20 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
Blood Potassium Decreased *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Blood Pressure Diastolic Decreased *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Heart Rate Irregular *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Urine Analysis Abnormal *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Urine Output Increased *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Weight Decreased *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia *  0/20 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
Back Pain *  2/20 (10.00%)  2 0/19 (0.00%)  0 2/20 (10.00%)  2
Joint Swelling *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Muscle Spasms *  1/20 (5.00%)  1 3/19 (15.79%)  3 2/20 (10.00%)  3
Muscle Tightness *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Muscular Weakness *  3/20 (15.00%)  5 3/19 (15.79%)  3 3/20 (15.00%)  3
Musculoskeletal Stiffness *  2/20 (10.00%)  2 1/19 (5.26%)  1 0/20 (0.00%)  0
Myalgia *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Neck Pain *  1/20 (5.00%)  1 0/19 (0.00%)  0 1/20 (5.00%)  2
Pain in Extremity *  0/20 (0.00%)  0 3/19 (15.79%)  3 0/20 (0.00%)  0
Sensation of Heaviness *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Nervous system disorders       
Balance Disorder *  0/20 (0.00%)  0 2/19 (10.53%)  2 1/20 (5.00%)  1
Crying *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Dizziness *  3/20 (15.00%)  4 6/19 (31.58%)  7 4/20 (20.00%)  4
Dysarthria *  0/20 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
Dysgeusia *  0/20 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
Headache *  2/20 (10.00%)  2 4/19 (21.05%)  6 2/20 (10.00%)  3
Hypoaesthesia *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Memory Impairment *  0/20 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
Muscle Contractions Involuntary *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Neuralgia *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Paraesthesia *  0/20 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
Tremor *  0/20 (0.00%)  0 5/19 (26.32%)  7 1/20 (5.00%)  1
Psychiatric disorders       
Affect Lability *  0/20 (0.00%)  0 3/19 (15.79%)  3 0/20 (0.00%)  0
Anxiety *  1/20 (5.00%)  1 3/19 (15.79%)  3 0/20 (0.00%)  0
Depression *  0/20 (0.00%)  0 2/19 (10.53%)  3 2/20 (10.00%)  2
Euphoric Mood *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Insomnia *  0/20 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
Nervousness *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders       
Chromaturia *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Pollakiuria *  1/20 (5.00%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Choking *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Cough *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Dyspnoea *  1/20 (5.00%)  1 1/19 (5.26%)  1 3/20 (15.00%)  4
Epistaxis *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Productive Cough *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Respiratory Failure *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Rhinorrhoea *  0/20 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
Throat Irritation *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Heat Rash *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Night Sweats *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Pruritus *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Skin Disorder *  1/20 (5.00%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Rash Pruritic *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Surgical and medical procedures       
Epidural Blood Patch *  0/20 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
Surgical Stapling *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Vascular disorders       
Flushing *  0/20 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Haematoma *  0/20 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael D. Weiss, MD
Organization: University of Washington
EMail: mdweiss@uw.edu
Layout table for additonal information
Responsible Party: Michael D Weiss, University of Washington
ClinicalTrials.gov Identifier: NCT01849770     History of Changes
Other Study ID Numbers: 43708-A
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: July 7, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015