Beta-hCG + Erythropoietin in Acute Stroke "BETAS"

Completed

Phase 2 Results

Trial Description

The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.

Detailed Description

Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.

Conditions

Interventions

  • Erythropoietin beta (EPO) Drug
  • Beta-hCG Drug
    Intervention Desc: Given IM.
  • Beta-hCG + Erythropoietin Drug
    Intervention Desc: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
  • Dual Growth Factor Drug
    Intervention Desc: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
    ARM 1: Kind: Experimental
    Label: Dual Growth Factor
    Description: All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Patient Involvement

Patients will undergo additional baseline testing including brain MRI; a 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety; morbidity; mortality.
Secondary Action Research Arm Test; Fugl-Meyer arm and leg motor scales; Boston Naming Test; Line Cancellation Test; NIH Stroke Scale; Geriatric Depression Scale; Barthel Index; Infarct volume using anatomical MRI; Trail Making A & B tests; Disability; Neurologic status; MRI.
Primary Safety 3 mo Yes
Primary morbidity 3 mo Yes
Primary mortality 3 mo Yes
Secondary Action Research Arm Test 3 mo Yes
Secondary Fugl-Meyer arm and leg motor scales 3 mo Yes
Secondary Boston Naming Test 3 mo Yes
Secondary Line Cancellation Test 3 mo Yes
Secondary NIH Stroke Scale 3 mo Yes
Secondary Geriatric Depression Scale 3 mo Yes
Secondary Barthel Index 3 mo Yes
Secondary Infarct volume using anatomical MRI 3 mo Yes
Secondary Trail Making A & B tests 3 mo Yes
Secondary Fugl-Meyer Arm Scale 3 mo No
Secondary Fugl-Meyer Leg Scale 3 mo. No
Secondary Geriatric Depression Scale Short Form 3 mo No
Secondary Trail Making A Test 3 mo No
Secondary Trail Making B Test 3 mo. No

Sponsors