CLINICAL TRIALS PROFILE FOR NRX-101

Clinical Trials for NRX-101

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02974010 ↗	Sequential Therapy for the Treatment of Severe Bipolar Depression.	Completed	Massachusetts General Hospital	Phase 2	NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.
NCT02974010 ↗	Sequential Therapy for the Treatment of Severe Bipolar Depression.	Completed	PPD	Phase 2	NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.
NCT02974010 ↗	Sequential Therapy for the Treatment of Severe Bipolar Depression.	Completed	Target Health Inc.	Phase 2	NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.
NCT02974010 ↗	Sequential Therapy for the Treatment of Severe Bipolar Depression.	Completed	NeuroRx, Inc.	Phase 2	NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.
NCT03395392 ↗	NRX101 for Moderate Bipolar Depression and Suicidal Ideation	Not yet recruiting	Bracket, Inc.	Phase 2/Phase 3	NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (the standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.
NCT03395392 ↗	NRX101 for Moderate Bipolar Depression and Suicidal Ideation	Not yet recruiting	Statistics Collaborative, Inc.	Phase 2/Phase 3	NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (the standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

Clinical Trial Conditions for NRX-101

Condition Name

Condition Name for
Intervention	Trials
Suicidal Ideation	6
Bipolar Depression	6
Suicidal Ideas	1
Suicide, Attempted	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Bipolar Disorder	6
Suicidal Ideation	6
Depressive Disorder	6
Depression	6

Clinical Trial Locations for NRX-101

Trials by Country

Trials by Country for
Location	Trials
United States	11

Trials by US State

Trials by US State for
Location	Trials
Texas	3
Florida	3
Alabama	2
New York	2
North Carolina	1

Clinical Trial Progress for NRX-101

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	2
Completed	1

Clinical Trial Sponsors for NRX-101

Sponsor Name

Sponsor Name for
Sponsor	Trials
Target Health Inc.	6
NeuroRx, Inc.	6
Bracket, Inc.	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	14
Other	5