Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients "REGENESIS-LED"

Terminated

Phase 2 Results

Trial Description

The purpose of this study is:
- To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
- To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

Trial Stopped: Slow Enrollment

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
  • NTx-265 Drug
    Intervention Desc: NTx-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin then Erythropoietin, targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke.
  • Saline placebo Drug
    Other Names: Sodium Chloride 0.9%
    Intervention Desc: Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation
    ARM 1: Kind: Experimental
    Label: Saline Placebo
  • RhCG, then rEPO Drug
    Other Names: Ovidrel; Ovitrelle; Epogen; Eprex
    Intervention Desc: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 1: Kind: Experimental
    Label: Cohort 1
    ARM 2: Kind: Experimental
    Label: Cohort 2
    ARM 3: Kind: Experimental
    Label: Cohort 3
  • HCG, then EPO Drug
    Other Names: Ovidrel; Ovitrelle; Epogen; Eprex
    Intervention Desc: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 1: Kind: Experimental
    Label: NTx®-265 Low Dose
    Description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 2: Kind: Experimental
    Label: NTx®-265 Medium Dose
    Description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 3: Kind: Experimental
    Label: NTx®-265 High Dose
    Description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
  • Human chorionic gonadotropin (hCG), then epoetin alfa (EPO) Drug
    Other Names: Ovidrel; Ovitrelle; Epogen; Eprex
    Intervention Desc: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 1: Kind: Experimental
    Label: NTx®-265 Low Dose
    Description: hCG 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
    ARM 2: Kind: Experimental
    Label: NTx®-265 Medium Dose
    Description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 3: Kind: Experimental
    Label: NTx®-265 High Dose
    Description: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will have mRS, NIHSS, Barthel Index, Action Research Arm Test, Gait Velocity Test, Boston Naming Test, Line Cancellation Test, Trails A & B Test, & Geriatric Depression Scale at baseline and 90 days. Patients will be randomized to one of 4 arms: Cohort 1: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation, Cohort 2: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation, Cohort 3: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation, or 4. Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation. In addition, patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated for their disease state.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Score; NIHSS response; Adverse events.
Secondary Barthel index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test; Geriatric Depression Scale.
Primary NIHSS response Day 90 No
Primary Adverse events Day 90 Yes
Secondary Barthel index Day 90 No
Secondary Action Research Arm Test Day 90 No
Secondary Gait Velocity Test Day 90 No
Secondary Boston Naming Test Day 90 No
Secondary Line Cancellation Test Day 90 No
Secondary Trails A & B Test Day 90 No
Secondary Geriatric Depression Scale Day 90 No
Secondary mRS Day 90 No
Primary National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 Baseline and Day 90 No
Secondary NIHSS Response >=4 at Day 90 Baseline and Day 90 No
Secondary NIHSS Change From Baseline at Day 30 Baseline and Day 30 No
Secondary Modified Rankin Scale (mRS) Response <=2 at Day 90 Day 90 No
Secondary Barthel Index at Day 90 Day 90 No
Secondary Action Research Arm Test (ARAT) Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Gait Velocity Test Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Boston Naming Test (BNT) Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Line Cancellation Test Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Trails A Test Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Trails B Test Change From Baseline at Day 90 Baseline and Day 90 No
Secondary Geriatric Depression Scale at Day 90 Day 90 No

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