Trial · NCT00406016
Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
NCT00406016, Phase 1, Completed, Novartis
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI. Trials, record NCT00406016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00406016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
- NCT number
- NCT00406016
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Acute Spinal Cord Injury
- Interventions
- ATI355
- First posted
- 2006-12-04
- Last updated
- 2020-02-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits. | 1 year | |
| Secondary | Immunogenicity of ATI355 in acute spinal cord injury patients up to one year. | 1 year | |
| Secondary | Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year. | 1 year |
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/NCT00406016
GET https://conductscience.org/api/trials/v1/NCT00406016/registered