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Mexiletine for the Treatment of Muscle Cramps in ALS

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ClinicalTrials.gov Identifier: NCT01811355
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : June 27, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
University of California, Davis
ALS Association
Information provided by (Responsible Party):
Bjorn Oskarsson, MD, University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscle Cramps in Amyotrophic Lateral Sclerosis
Interventions Drug: Mexiletine
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details Of 28 patients who signed consent, 5 did not meet inclusion criteria because of past myocardial infarction (n=1), long QT syndrome (n=1), AV block (n=1), no muscle cramps (n=1), and hospitalization during the screening period that resulted in inability to complete a screening diary and follow-up (n=1) .
Arm/Group Title Mexiletine First/Placebo Second Placebo First/Mexiletine Second
Hide Arm/Group Description

Mexiletine, capsule, 150mg, PO BID, 14 days

Placebo, capsule, PO BID, 14 days

Placebo, capsule, PO BID, 14 days

Mexiletine, capsule, 150mg, PO BID, 14 days

Period Title: First Dose
Started 11 12
Completed 9 12
Not Completed 2 0
Period Title: Washout
Started 9 12
Completed 9 12
Not Completed 0 0
Period Title: Second Dose
Started 9 12
Completed 9 12
Not Completed 0 0
Arm/Group Title Total Subjects Enrolled
Hide Arm/Group Description A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 23 participants
62.4  (12.5)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
males
15
  65.2%
females
8
  34.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Hispanic or Latino
3
  13.0%
Not Hispanic or Latino
20
  87.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
22
  95.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Daily Muscle Cramps
Hide Description The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.
Arm/Group Title Mexiletine First/Placebo Second Placebo First/Mexiletine Second
Hide Arm/Group Description:

Mexiletine, capsule, 150mg, PO BID, 14 days

Placebo, capsule, PO BID, 14 days

Placebo, capsule, PO BID, 14 days

Mexiletine, capsule, 150mg, PO BID, 14 days

Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: Cramps per 24 hours
Placebo Dose 6.1  (8.1) 4.7  (4.2)
Mexiletine Dose 4.9  (8.0) 2.5  (2.8)
Difference Between 1.2  (2.9) 2.2  (2.2)
2.Primary Outcome
Title Cramp Severity
Hide Description Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.
Arm/Group Title Mexiletine First Placebo First
Hide Arm/Group Description:

Mexiletine, capsule, 150mg, PO BID, 14 days

Mexiletine: Sodium channel blocker

Placebo, capsule, PO BID, 14 days

Placebo: Placebo

Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo Dose 43.6  (31.0) 44.7  (26.7)
Mexiletine Dose 23.1  (16.8) 32.8  (27.7)
Difference Between 20.5  (40.6) 12.0  (18.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mexiletine Placebo
Hide Arm/Group Description

Mexiletine, capsule, 150mg, PO BID, 14 days

Mexiletine: Sodium channel blocker

Placebo, capsule, PO BID, 14 days

Placebo: Placebo

All-Cause Mortality
Mexiletine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
Mexiletine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mexiletine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/23 (39.13%)      3/21 (14.29%)    
Ear and labyrinth disorders     
Congestion * [1]  0/23 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders     
Dry mouth * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Nausea * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Diarrhea * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Nervous system disorders     
Dizzines * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Fall   1/23 (4.35%)  1 1/21 (4.76%)  1
Headache * [1]  1/23 (4.35%)  1 1/21 (4.76%)  1
Renal and urinary disorders     
Increased urination * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chest tightness * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Itchiness * [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Mild
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bjorn Oskarsson
Organization: Mayo Clinic, Jacksonville
Phone: 9049536896
EMail: oskarsson.bjorn@mayo.edu
Layout table for additonal information
Responsible Party: Bjorn Oskarsson, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01811355    
Other Study ID Numbers: 378164
First Submitted: March 6, 2013
First Posted: March 14, 2013
Results First Submitted: April 3, 2017
Results First Posted: June 27, 2017
Last Update Posted: August 28, 2017