REGENESIS (US): A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients "REGENESIS"

Withdrawn

Phase 2 Results N/A

Trial Description

To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.

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.
  • NTx™-265: rhCG, then rEPO Drug
    Other Names: Ovidrel; Epogen
    Intervention Desc: rhCG 385 µg, SC, on Day 1, 3, and 5 of study participation, then rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation
    ARM 1: Kind: Experimental
    Label: 1
  • 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: 2

Trial Design

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

Patient Involvement

Patients will be randomized to either experimental arm with NTx™-265: rhCG, then rEPO (rhCG 385 µg, SC, on Day 1, 3, and 5 of study participation, then rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation) or placebo saline IV at same intervals. Then patients will have baseline and 90 day testing using mRS; NIHSS, Barthel Index, Action Research Arm Test, Gait Velocity Test, Boston Naming Test, Line Cancellation Test, and Trails A & B Test.

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse events
Secondary mRS; NIHSS; Barthel Index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test.
Secondary mRS Day 90 No
Secondary NIHSS Day 90 No
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

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