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Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

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: NCT02561702
Recruitment Status : Completed
First Posted : September 28, 2015
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
David Herrmann, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Charcot Marie Tooth Disease
Interventions Other: Placebo
Drug: Mexiletine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mexiletine First/Placebo Second Placebo First/Mexiletine Second
Hide Arm/Group Description

Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Period Title: First Intervention
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: Washout
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: Second Intervention
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Number of Participants With a Decrease in Cramp Duration
Hide Description Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp duration in seconds of the right hamstring was used.
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine Placebo
Hide Arm/Group Description:

Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: participants
2 0
2.Primary Outcome
Title Number of Participants With a Decrease in Cramp Intensity
Hide Description Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp intensity of the right hamstring was reported by the subject on a scale of 1-10 with 1 being weak and 10 being severe.
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mexiletine Placebo
Hide Arm/Group Description:

Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: participants
1 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mexiletine Placebo
Hide Arm/Group Description

Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

All-Cause Mortality
Mexiletine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Mexiletine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mexiletine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
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: David Herrmann
Organization: University of Rochester
Phone: 585-275-4568
EMail: david_herrmann@urmc.rochester.edu
Layout table for additonal information
Responsible Party: David Herrmann, University of Rochester
ClinicalTrials.gov Identifier: NCT02561702    
Other Study ID Numbers: RSRB00057653
First Submitted: September 24, 2015
First Posted: September 28, 2015
Results First Submitted: January 25, 2018
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018