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

Terminated

Phase 2 Results N/A

Trial Description

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

Conditions

Interventions

  • Epoetin Alfa (Procrit and Epogen)Drug
    Other Names: Procrit
    Intervention Desc: Used to treat anemia, to decrease the need for red blood cell transfusions. Usually given by subcutaneous injection.
  • Human chorionic gonadotropin Drug
    Intervention Desc: Human chorionic gonadotropin (hCG) is a peptide hormone produced in pregnancy that is made by the embryo soon after conception and later by the syncytiotrophoblast (part of the placenta). Its role is to prevent the disintegration of the corpus luteum of the ovary and thereby maintain progesterone production that is critical for a pregnancy in humans.
  • NTx™-265: rhCG, then rEPO Drug
    Other Names: Ovidrel; Epogen
    Intervention Desc: rhCG 10,000 IU, 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

Patient will be randomized to one of two arms. On the drug arm patient will receiv rhCG, then rEPO. rhCG 10,000 IU, 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. On the saline placebo arm, the patient will recieve saline SC, on Day 1, 3, and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation. Patient will return for testing in 90 days for 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 Modified Rankin Score (mRS); NIHSS response.
Secondary NIHSS; mRS; Barthel Index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test.
Primary Modified Rankin Score (mRS) Day 90 No
Primary NIHSS response Day 90 No
Secondary NIHSS Day 90 No
Secondary mRS 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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