We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mexiletine for the Treatment of Muscle Cramps in ALS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01811355
First Posted: March 14, 2013
Last Update Posted: August 28, 2017
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.
Collaborators:
University of California, Davis
ALS Association
Information provided by (Responsible Party):
Bjorn Oskarsson, MD, University of California, Davis
Results First Submitted: April 3, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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) .

Reporting Groups
  Description
Mexiletine First/Placebo Second

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

Placebo, capsule, PO BID, 14 days

Placebo First/Mexiletine Second

Placebo, capsule, PO BID, 14 days

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


Participant Flow for 3 periods

Period 1:   First Dose
    Mexiletine First/Placebo Second   Placebo First/Mexiletine Second
STARTED   11   12 
COMPLETED   9   12 
NOT COMPLETED   2   0 

Period 2:   Washout
    Mexiletine First/Placebo Second   Placebo First/Mexiletine Second
STARTED   9   12 
COMPLETED   9   12 
NOT COMPLETED   0   0 

Period 3:   Second Dose
    Mexiletine First/Placebo Second   Placebo First/Mexiletine Second
STARTED   9   12 
COMPLETED   9   12 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Subjects Enrolled 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.

Baseline Measures
   Total Subjects Enrolled 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 
Years   62.4  (12.5) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
 
males   15 
females   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3  13.0% 
Not Hispanic or Latino      20  87.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Daily Muscle Cramps   [ Time Frame: 6 weeks ]

2.  Primary:   Cramp Severity   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Dr. Bjorn Oskarsson
Organization: Mayo Clinic, Jacksonville
phone: 9049536896
e-mail: oskarsson.bjorn@mayo.edu



Responsible Party: Bjorn Oskarsson, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01811355     History of Changes
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