Trial · NCT01849770
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12 | Week 3-12, post titration of study medication | |
| Other | 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 | The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival. |
| Other | Change in Slow Vital Capacity (SVC) Score | Week 0, Week 6, and Week 12 (or Early Termination Date) | The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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