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Trial Outcomes & Findings for Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease (NCT NCT02561702)

NCT ID: NCT02561702

Last Updated: 2018-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

120 minutes

Results posted on

2018-03-26

Participant Flow

Participant milestones

Participant milestones
Measure
Mexiletine First/Placebo Second
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
Placebo First/Mexiletine Second
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
First Intervention
STARTED
2
2
First Intervention
COMPLETED
2
2
First Intervention
NOT COMPLETED
0
0
Washout
STARTED
2
2
Washout
COMPLETED
2
2
Washout
NOT COMPLETED
0
0
Second Intervention
STARTED
2
2
Second Intervention
COMPLETED
2
2
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=4 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
United States
4 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes

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.

Outcome measures

Outcome measures
Measure
Mexiletine
n=4 Participants
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
Placebo
n=4 Participants
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
Number of Participants With a Decrease in Cramp Duration
2 participants
0 participants

PRIMARY outcome

Timeframe: 120 minutes

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.

Outcome measures

Outcome measures
Measure
Mexiletine
n=4 Participants
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
Placebo
n=4 Participants
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
Number of Participants With a Decrease in Cramp Intensity
1 participants
2 participants

Adverse Events

Mexiletine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Herrmann

University of Rochester

Phone: 585-275-4568

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place