Trial · NCT06300307
Study of ATX-01 in Participants With DM1
NCT06300307, Phase 1, Phase 2, Recruiting, ARTHEx Biotech S.L.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of ATX-01 in Participants With DM1. Trials, record NCT06300307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06300307
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ATX-01 in Participants With DM1
- NCT number
- NCT06300307
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 56 participants, estimated
- Lead sponsor
- ARTHEx Biotech S.L.
- Conditions
- Myotonic Dystrophy 1
- Interventions
- ATX-01, Placebo
- First posted
- 2024-03-08
- Last updated
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events | Up to 120 days | To evaluate the safety and tolerability of ATX-01 in adult participants with DM1 |
| Secondary | Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior | Up to 120 days | To further evaluate the safety and tolerability of ATX-01 in adult participants with DM1 |
| Secondary | Maximum observed plasma concentration (Cmax) of ATX-01 | Up to 48 hours post-dose | |
| Secondary | Area under the plasma concentration-time curve (AUC) of ATX-01 | Up to 48 hours post-dose | |
| Secondary | Video hand opening time | Change from baseline up to 120 days | To evaluate the efficacy of ATX-01 on myotonia in participants with DM1 |
| Secondary | Change from baseline in ankle dorsiflexion strength by quantitative myometry | Change from baseline up to 120 days | To evaluate the effects of ATX-01 in participants with DM1 on ankle dorsiflexion strength |
| Secondary | Change from baseline in Impact on Activities of Daily Living questionnaire item scores | Change from baseline up to 120 days | The Impact on Activities of Daily Living questionnaire is a 7-item patient-reported outcome designed to evaluate the impact of ATX-01 on activities of daily living in participants with DM1. |
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/NCT06300307
GET https://conductscience.org/api/trials/v1/NCT06300307/registered