Trial · NCT07093268
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal vital signs | 6 weeks | Serial assessment of adverse events, vital signs (blood pressure, pulse, respiratory rate and temp) |
| Primary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with with abnormal physical examination findings | 6 weeks | Serial assessment of abnormal findings in a neurological examination for ALS patients |
| Primary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal neurological exam findings | 6 weeks | Serial assessment all adverse events, neurological examination |
| Primary | Safety and tolerability of 0.2mg/hr intrathecal, infusion of intrathecal riluzole, Number of participants with with abnormal laboratory tests results | 6 weeks | Serial assessment all abnormal findings in clinical laboratory test results |
| Primary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal findings in the Neuropathic Pain Scale (NPS) | 6 weeks | Serial assessment all abnormal findings in the Neuropathic Pain Scale (NPS) |
| Primary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS). | 6 weeks | Serial assessment all adverse events in the Columbia-Suicide Severity Rating Scale (C-SSRS). |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal vital signs | 6 months | Serial assessment of adverse events, vital signs (blood pressure, pulse, respiratory rate and temp) |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal physical examination findings | 6 months | Serial assessment of abnormal findings in a neurological examination for ALS patients |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal neurological exam findings | 6 months | Serial assessment all adverse events, neurological examination |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal, infusion of intrathecal riluzole, Number of participants with with abnormal laboratory tests results | 6 months | Serial assessment all abnormal clinical laboratory test results |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with abnormal findings in the Neuropathic Pain Scale (NPS) | 6 months | Serial assessment all abnormal findings in the Neuropathic Pain Scale (NPS) |
| Secondary | Safety and tolerability of 0.2mg/hr intrathecal infusion of intrathecal riluzole, Number of participants with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS). | 6 months | Serial assessment all adverse events in the Columbia-Suicide Severity Rating Scale (C-SSRS). |
| Other | Exploratory - Measure of changes in blood and cerebrospinal fluid biomarkers and urinary p75 | 9 months | Measure of BDNF, pNFH and NfL) and cerebrospinal fluid (pNFH, NfL, Chit-1, CHI3L1, MCP-1, IL-6, IL-8, IL-17, IL-18, MIP-1α, TNF-α, CRP, 8-oxodG, Ferritin, BDNF, NGF, p75ECD biomarkers |
| Other | Exploratory - Measure of clinical outcome of Handheld dynamometry (HHD) during dosing and post treatment periods. | 9 months | Measure of Handheld dynamometry (HHD) |
| Other | Exploratory - Tracheostomy free survival | 9 months | To compare tracheostomy free survival for all participants with data from historical controls |
| Other | Exploratory - Measure of clinical outcome measures during dosing and post treatment periods. | 9 months | Measure of the ALS Functional Rating Scale - Revised (ALSFRS-R), |
| Other | Exploratory - Measure of clinical outcome measures during dosing and post treatment periods. | 9 months | Measure of slow vital capacity (SVC), |
| Other | Exploratory - Measure of clinical outcome measures during dosing and post treatment periods. | 9 months | Measure of the Rasch-Built Overall ALS Disability Scale (ROADS), |
| Other | Exploratory - Measure of clinical outcome measures during dosing and post treatment periods. | 9 months | Measure of the Amyotrophic Lateral Sclerosis-Specific Quality of Life-short form (ALSSQOL-SF) |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07093268/registered