Trial · NCT01849770
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)
NCT01849770, Phase 2, Completed, University of Washington; results first posted 2015-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS). Trials, record NCT01849770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01849770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)
- NCT number
- NCT01849770
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Sporadic Amyotrophic Lateral Sclerosis
- Interventions
- Mexiletine, Placebo
- First posted
- 2013-05-08
- Last updated
- 2021-09-29
- Results first posted
- 2015-10-12
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants That Discontinued Study Drug | Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16. | Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results. |
| Secondary | Trough Plasma Concentration (Cmin) of Mexiletine | Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6) | Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit. |
| Secondary | Peak Plasma Concentration (Cmax) of Mexiletine | Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6) | Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit. |
| Secondary | Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma. | Week 6 Visit (up to 6 hours post dose) | Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit. |
| Secondary | Mean Cerebrospinal Fluid (CSF)/Plasma Ratio | Week 6 Visit (up to 6 hours post dose) | The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma. |
| Secondary | Mean Weekly Cramp Frequency | Week 3-12, post titration of study medication | |
| Secondary | Maximal Pain Severity | Weeks 3-12, post titration of study medication | At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily. |
| Secondary | Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12 | Week 3-12, post titration of study medication | |
| Secondary | Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12 | Week 3-12, post titration of study medication | |
| Secondary | Mean Pain Severity | Weeks 3-12, post titration of study medication | At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days. The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms. Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants That Discontinued Study Drug | Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16. | percentage of participants | NUMBER | |
| SECONDARY | Trough Plasma Concentration (Cmin) of Mexiletine | Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6) | pg/mL | MEAN | |
| SECONDARY | Peak Plasma Concentration (Cmax) of Mexiletine | Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6) | pg/mL | MEAN | |
| SECONDARY | Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma. | Week 6 Visit (up to 6 hours post dose) | µg*hr/mL | MEAN | |
| SECONDARY | Mean Cerebrospinal Fluid (CSF)/Plasma Ratio | Week 6 Visit (up to 6 hours post dose) | ratio | MEAN | |
| SECONDARY | Mean Weekly Cramp Frequency | Week 3-12, post titration of study medication | cramps/week | MEAN | |
| OTHER_PRE_SPECIFIED | Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score | Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16 | scores on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Slow Vital Capacity (SVC) Score | Week 0, Week 6, and Week 12 (or Early Termination Date) | percent of predicted normal | MEAN | |
| SECONDARY | Maximal Pain Severity | Weeks 3-12, post titration of study medication | units on a scale | MEAN | |
| SECONDARY | Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12 | Week 3-12, post titration of study medication | ratio | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants That Discontinued Study Drug | Mexiletine, 300 Milligrams | 5 | percentage of participants | ||
| Percentage of Participants That Discontinued Study Drug | Mexiletine, 900 Milligrams | 32 | percentage of participants | ||
| Percentage of Participants That Discontinued Study Drug | Placebo | 5 | percentage of participants | ||
| Trough Plasma Concentration (Cmin) of Mexiletine | Mexiletine, 300 Milligrams | 0.23 | Standard Deviation 0.15 | pg/mL | |
| Trough Plasma Concentration (Cmin) of Mexiletine | Mexiletine, 900 Milligrams | 0.68 | Standard Deviation 0.38 | pg/mL | |
| Trough Plasma Concentration (Cmin) of Mexiletine | Placebo | 0 | Standard Deviation 0 | pg/mL | |
| Peak Plasma Concentration (Cmax) of Mexiletine | Mexiletine, 300 Milligrams | 0.41 | Standard Deviation 0.19 | pg/mL | |
| Peak Plasma Concentration (Cmax) of Mexiletine | Mexiletine, 900 Milligrams | 1.27 | Standard Deviation 0.67 | pg/mL | |
| Peak Plasma Concentration (Cmax) of Mexiletine | Placebo | 0 | Standard Deviation 0 | pg/mL | |
| Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma. | Mexiletine, 300 Milligrams | 2.34 | Standard Deviation 1.08 | µg*hr/mL |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mexiletine, 300 Milligrams | 20 | |
| Overall Study | STARTED | Mexiletine, 900 Milligrams | 19 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Mexiletine, 300 Milligrams | 20 | |
| Overall Study | COMPLETED | Mexiletine, 900 Milligrams | 15 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Mexiletine, 300 Milligrams | 0 | |
| Overall Study | NOT COMPLETED | Mexiletine, 900 Milligrams | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events309
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 | Tinnitus | Ear and labyrinth disorders | Mexiletine, 300 Milligrams | 0 | 20 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Mexiletine, 900 Milligrams | 1 | 19 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 0 | 20 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Mexiletine, 300 Milligrams | 1 | 20 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Mexiletine, 900 Milligrams | 2 | 19 | 2 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Abdominal Distension | Gastrointestinal disorders | Mexiletine, 300 Milligrams | 0 | 20 | 0 |
| other | Abdominal Distension | Gastrointestinal disorders | Mexiletine, 900 Milligrams | 1 | 19 | 1 |
| other | Abdominal Distension | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Mexiletine, 300 Milligrams | 0 | 20 | 0 |
1 to 10 of 309Source ClinicalTrials.gov
See all 309 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mexiletine, 300 Milligrams | ||
| Total, all-cause mortality | Mexiletine, 900 Milligrams | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mexiletine, 300 Milligrams | 17 | 20 |
| Total, other adverse events | Mexiletine, 900 Milligrams | 19 | 19 |
| Total, other adverse events | Placebo | 18 | 20 |
| Total, serious adverse events | Mexiletine, 300 Milligrams | 0 | 20 |
| Total, serious adverse events | Mexiletine, 900 Milligrams | 1 | 19 |
| Total, serious adverse events | Placebo | 2 | 20 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01849770
GET https://conductscience.org/api/trials/v1/NCT01849770/results?page=2