Trial · NCT05163886
Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis
NCT05163886, Phase 2, Completed, IRulya Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis. Trials, record NCT05163886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05163886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis
- NCT number
- NCT05163886
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- IRulya Therapeutics Inc.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Interventions
- LAM-002A, Placebo
- First posted
- 2021-12-20
- Last updated
- 2026-09-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of LAM-002A: Occurrence of TEAEs and SAEs | 24 Weeks | Number of Participants with Treatment-Related Adverse Events (TEAEs) and Serious Adverse Events |
| Primary | Tolerability of LAM-002A: Completion of Core Study Treatment | 12 Weeks | The percentage of participants who complete 12 weeks on study treatment during the Core Study. |
| Primary | Plasma Pharmacokinetics of LAM-002A and Major Metabolites | 24 Weeks | The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) in plasma. |
| Primary | CSF Pharmacokinetics of LAM-002A and Major Metabolites | 24 Weeks | The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) cerebral spinal fluid (CSF). |
| Secondary | Changes in Plasma Level of sGPNMB | 12 Weeks | Changes in plasma levels of the LAM-002A-induced biomarker, soluble glycoprotein nonmetastatic melanoma protein B (sGPNMB) |
| Secondary | Changes in CSF Level of sGPNMB | 12 Weeks | Changes in cerebrospinal fluid (CSF) levels of the LAM-002A-induced biomarker, soluble glycoprotein nonmetastatic melanoma protein B (sGPNMB) |
| Secondary | Tolerability of LAM-002A: Completion of Open-label Study Treatment | 24 Weeks | Secondary measures of tolerability will consider completion of 12 weeks on open-label study treatment during the OLE through study Week 24. |
| Other | Changes in ALSFRS-R Total Score and Domain Scores | 24 Weeks | Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) total and domain scores. The assessment consists of 12 everyday tasks, grouped into four main domains. Each task is scored from 0 (complete loss of function) to 4 (normal ability). The total score is the sum of the domain scores (bulbar: 0-12 points; fine motor: 0-12 points; gross motor: 0-12 points; respiratory: 0-12 points). The maximum total score is 48 points, with the higher the score indicating better function. |
| Other | Percent Predicted Slow Vital Capacity | 24 Weeks | The percent predicted in slow vital capacity (SVC) over time. Predicted and Percent predicted values for slow vital capacity (SVC) were calculated using Quanjer Global Lung Initiative (GLI) equations based on participant age, sex, height at baseline, and self-reported race/ethnicity matched to GLI categories. |
| Other | Permanent Assisted Ventilation-free Survival | 24 Weeks | Number of participants that required permanent-assisted-ventilation (or died) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38606777 | DERIVED |
Source PubMed
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/NCT05163886
GET https://conductscience.org/api/trials/v1/NCT05163886/registered