Trial · NCT06862596
Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
NCT06862596, Phase 2, Phase 3, Recruiting, Masahisa Katsuno
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy. Trials, record NCT06862596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06862596
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
- NCT number
- NCT06862596
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 68 participants, estimated
- Lead sponsor
- Masahisa Katsuno
- Conditions
- Spinal and Bulbar Muscular Atrophy
- Interventions
- Mexiletine hydrochloride, Placebo
- First posted
- 2025-03-06
- Last updated
- 2025-04-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score | at 4weeks | The ALSFRS-R is a comprehensive severity index comprising 12 items covering bulbar, upper limb, lower limb, and respiratory symptoms to evaluate the ADLs of patients with amyotrophic lateral sclerosis (ALS). Each item is rated on a five-point scale from 0 (worse) to 4 (better), and a total score (miniimum 0point and maximum 48 point) is calculated. |
| Secondary | ALSFRS-R Score | up to 12 weeks | The ALSFRS-R is a comprehensive severity index comprising 12 items covering bulbar, upper limb, lower limb, and respiratory symptoms to evaluate the ADLs of patients with ALS. Each item is rated on a five-point scale from 0 (worse) to 4 (better), and a total score (miniimum 0point and maximum 48 point) is calculated. |
| Secondary | Spinal and Bulbar Muscular Atrophy Functional Rating Scale (SBMAFRS) score | up to 12 weeks | The SBMAFRS is a disease-specific motor function assessment scale for Spinal and Bulbar Muscular Atrophy (SBMA).The SBMAFRS is a comprehensive severity index comprising 14 items covering bulbar, upper limb, lower limb, and respiratory symptoms to evaluate the ADLs of patients. Each item is rated on a five-point scale from 0 (worse) to 4 (better), and a total score (miniimum 0point and maximum 56 point) is calculated. |
| Secondary | Grip strength | up to 12 weeks | Grip strength (kg) is set to evaluate the upper limb motor function of patients with SBMA. |
| Secondary | Tongue pressure | up to 12 weeks | Tongue pressure (kPa) is set to evaluate the bulbar function of patients with SBMA. |
| Secondary | Timed walk test (4.6 meters) | up to 12 weeks | The timed walk test (4.6 meters) is an evaluation index for muscle weakness and atrophy of the lower limbs that measures the walking time (in seconds). |
| Secondary | 6-minute walk test | up to 12 weeks | The 6-minute walk test is an evaluation index for lower limb muscle weakness and muscle atrophy that measures the walking distance (in meters). |
| Secondary | Respiratory function test (Forced Vital Capacity (FVC)) | up to 12 weeks | FVC (actual value (L) and predicted rate (%) (%FVC)) is set to evaluate for respiratory function. |
| Secondary | Respiratory function test (Peak Expiratory Flow (PEF)) | up to 12 weeks | PEF (actual value (L/sec) and predicted rate (%) (%PEF)) is set to evaluate for respiratory function. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06862596
GET https://conductscience.org/api/trials/v1/NCT06862596/registered