Trial · NCT01811355

Mexiletine for the Treatment of Muscle Cramps in ALS

NCT01811355, Phase 4, Completed, Bjorn Oskarsson, MD; results first posted 2017-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mexiletine for the Treatment of Muscle Cramps in ALS. Trials, record NCT01811355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01811355

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mexiletine for the Treatment of Muscle Cramps in ALS
NCT number: NCT01811355
Status: Completed
Phases: Phase 4
Enrollment: 23 participants, actual
Lead sponsor: Bjorn Oskarsson, MD
Conditions: Muscle Cramps in Amyotrophic Lateral Sclerosis
Interventions: Mexiletine, Placebo
First posted: 2013-03-14
Last updated: 2017-08-28
Results first posted: 2017-06-27

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Daily Muscle Cramps	6 weeks	The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.
Primary	Cramp Severity	6 weeks	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

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Daily Muscle Cramps	6 weeks	Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.	Cramps per 24 hours	MEAN
PRIMARY	Cramp Severity	6 weeks	Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Daily Muscle Cramps	Mexiletine First/Placebo Second	Placebo Dose	6.1	Standard Deviation 8.1	Cramps per 24 hours
Daily Muscle Cramps	Placebo First/Mexiletine Second	Placebo Dose	4.7	Standard Deviation 4.2	Cramps per 24 hours
Daily Muscle Cramps	Mexiletine First/Placebo Second	Mexiletine Dose	4.9	Standard Deviation 8.0	Cramps per 24 hours
Daily Muscle Cramps	Placebo First/Mexiletine Second	Mexiletine Dose	2.5	Standard Deviation 2.8	Cramps per 24 hours
Daily Muscle Cramps	Mexiletine First/Placebo Second	Difference Between	1.2	Standard Deviation 2.9	Cramps per 24 hours
Daily Muscle Cramps	Placebo First/Mexiletine Second	Difference Between	2.2	Standard Deviation 2.2	Cramps per 24 hours
Cramp Severity	Mexiletine First	Placebo Dose	43.6	Standard Deviation 31.0	units on a scale
Cramp Severity	Placebo First	Placebo Dose	44.7	Standard Deviation 26.7	units on a scale
Cramp Severity	Mexiletine First	Mexiletine Dose	23.1	Standard Deviation 16.8	units on a scale
Cramp Severity	Placebo First	Mexiletine Dose	32.8	Standard Deviation 27.7	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Dose	STARTED	Mexiletine First/Placebo Second	11
First Dose	STARTED	Placebo First/Mexiletine Second	12
First Dose	COMPLETED	Mexiletine First/Placebo Second	9
First Dose	COMPLETED	Placebo First/Mexiletine Second	12
First Dose	NOT COMPLETED	Mexiletine First/Placebo Second	2
First Dose	NOT COMPLETED	Placebo First/Mexiletine Second	0
Washout	STARTED	Mexiletine First/Placebo Second	9
Washout	STARTED	Placebo First/Mexiletine Second	12
Washout	COMPLETED	Mexiletine First/Placebo Second	9
Washout	COMPLETED	Placebo First/Mexiletine Second	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizzines	Nervous system disorders	Mexiletine	1	23	1
other	Dizzines	Nervous system disorders	Placebo	0	21	0
other	Fall	Nervous system disorders	Mexiletine	1	23	1
other	Fall	Nervous system disorders	Placebo	1	21	1
other	Headache	Nervous system disorders	Mexiletine	1	23	1
other	Headache	Nervous system disorders	Placebo	1	21	1
other	Congestion	Ear and labyrinth disorders	Mexiletine	0	23	0
other	Congestion	Ear and labyrinth disorders	Placebo	1	21	1
other	Chest tightness	Respiratory, thoracic and mediastinal disorders	Mexiletine	1	23	1
other	Chest tightness	Respiratory, thoracic and mediastinal disorders	Placebo	0	21	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mexiletine	0	23
Total, all-cause mortality	Placebo	0	21
Total, other adverse events	Mexiletine	9	23
Total, other adverse events	Placebo	3	21
Total, serious adverse events	Mexiletine	0	23
Total, serious adverse events	Placebo	0	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mexiletine vs Placebo: deaths from any cause	Trial comparisons
Mexiletine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01811355

GET https://conductscience.org/api/trials/v1/NCT01811355/registered

API reference For AI assistants