Trial · NCT05163886
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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) |
| Other | Changes in ALS-CBS | 24 Weeks | Change in Amyotrophic Lateral Sclerosis Cognitive Behavioral Scale (ALS-CBS). Comprised of two sub-scores. The cognitive sub-score is rated 0-20 with the higher the score the better patient cognitive function. The behavioral sub-score was assessed by the caregiver and is rated 0-45 with the higher the score the better patient behavioral function. |
| Other | CSF Levels of NfL | 24 Weeks | Changes in cerebrospinal fluid (CSF) levels of the exploratory disease related biomarker, neurofilament light chain (NfL). Decreases in NfL are considered positive pharmacological effects of LAM-002A. |
| Other | Plasma Levels of NfL | 12 Weeks | Changes in plasma levels of the exploratory disease related biomarker, neurofilament light chain (NfL). Decreases in NfL are considered positive pharmacological effects of LAM-002A. |
| Other | CSF Levels of Poly (GP) Dipeptide Repeats | 24 Weeks | Changes in cerebrospinal fluid (CSF) levels of the exploratory disease related biomarker, Poly(GP) dipeptide repeats. Decreases in poly (GP) are considered positive pharmacological effects of LAM-002A. |
| Other | PBMC Levels of Poly (GP) Dipeptide Repeats | 24 Weeks | Changes in peripheral blood mononuclear cells (PBMC) levels of the exploratory disease related biomarker, Poly(GP) dipeptide repeats. Decreases in poly (GP) are considered positive pharmacological effects of LAM-002A. |
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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