Restoring Awareness
NCT07918274, Phase 2, Not yet recruiting, Casa Colina Hospital and Centers for Healthcare
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Restoring Awareness | ClinicalTrials.gov |
| NCT number | NCT07918274 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 24 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Casa Colina Hospital and Centers for Healthcare | ClinicalTrials.gov |
| Conditions | Vegetative State, Minimally Conscious State | ClinicalTrials.gov |
| Interventions | Saxagliptin (Mylan Pharmaceuticals Inc., NDC: 0378-4706-93), Saxagliptin (Mylan Pharmaceuticals Inc., NDC: 0378-4706-93) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of serious adverse events (SAEs) | From days 1-30 | Hypoglycemia (\<70 mg/dL via continuous glucose monitoring), non-serious AEs (CTCAE v5.0), and discontinuations vs. placebo (first 15 days), and vitals. | ClinicalTrials.gov |
| Primary | Change in CRS-R total score from baseline to Day 15 (placebo-controlled comparison) and Day 30. | Baseline, Days 15 and Days 30 | CRS-R assessment divided into 6 subscales Total score ranging from 0-23. Higher scores indicate higher levels of neurological function and consciousness. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Secondary | CRS-R subscales | Baseline, day 15, day 30 | ≥2-point increase or diagnostic advancement. DRS is out of 29 points (Scores range from 0 (no disability) to 29 (extreme vegetative state). Higher scores mean a better outcome. | ClinicalTrials.gov |
| Secondary | Portable EEG-based AI biomarker of consciousness level | Baseline, days 15, days 30 | A framework to decode consciousness level | ClinicalTrials.gov |
| Secondary | DRS-PI | Days 60 and Days 90 | The DRS-PI (Disability Rating Scale-Postacute Interview) is a standardized interview version of the Disability Rating Scale (DRS) designed for reliable telephone or direct administration with patients or proxy caregivers. Lower DRS-PI better outcome. Lower scores mean a better outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 17
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 11083347 | BACKGROUND | PubMed |
| 11839831 | BACKGROUND | PubMed |
| 15605342 | BACKGROUND | PubMed |
| 16616561 | BACKGROUND | PubMed |
| 19117180 | BACKGROUND | PubMed |
| 19444391 | BACKGROUND | PubMed |
| 20658796 | BACKGROUND | PubMed |
| 22123095 | BACKGROUND | PubMed |
| 22224835 | BACKGROUND | PubMed |
| 22725684 | BACKGROUND | PubMed |
| 22901094 | BACKGROUND | PubMed |
| 26609059 | BACKGROUND | PubMed |
| 28901969 | BACKGROUND | PubMed |
| 30801440 | BACKGROUND | PubMed |
| 33099022 | BACKGROUND | PubMed |
| 39904872 | BACKGROUND | PubMed |
| 40214844 | BACKGROUND | PubMed |
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)