Trial · NCT07093268
Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis
NCT07093268, Phase 1, Not yet recruiting, Brain Trust Bio
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis. Trials, record NCT07093268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07093268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis
- NCT number
- NCT07093268
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Brain Trust Bio
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- Interventions
- Intrathecal Riluzole
- First posted
- 2025-07-30
- Last updated
- 2025-07-30
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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.
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/NCT07093268
GET https://conductscience.org/api/trials/v1/NCT07093268/registered