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

NCT00715364 | Withdrawn Phase 2 DMC

• 1 other identifier: NTx™-265-CP-201-IS (US)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Stroke

Outcome Measures

Primary Outcomes (1)

• Adverse events

  screening to Day 90

Secondary Outcomes (8)

• mRS

  Day 90

• NIHSS

  Day 90

• Barthel Index

  Day 90

• Action Research Arm Test

  Day 90

• Gait Velocity Test

  Day 90

Study Arms (2)

1

EXPERIMENTAL

Drug: NTx™-265: rhCG, then rEPO

2

PLACEBO COMPARATOR

Drug: Saline Placebo

Interventions

NTx™-265: rhCG, then rEPO DRUG

* 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

Also known as: Ovidrel, Epogen

1

Saline Placebo DRUG

* Saline SC, on Day 1, 3, and 5 of study participation, then * Saline IV, on Day 7, 8, and 9 of study participation

Also known as: Sodium Chloride 0.9%

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85.
• NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
• Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
• Patient is 24-48 hours from time of stroke onset when the first dose of NTx™-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
• Reasonable expectation of availability to receive the full 9 day NTx™-265 course of therapy, and to be available for subsequent follow-up visits.
• Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated.
• Female patient is either:
• not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
• if of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow up visits: i) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (e.g. implants, injectables, combined oral, etc.) OR ii) a vasectomized partner OR iii) abstinence

You may not qualify if:

• Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
• Patients classified as comatose, defined as a patient who requires repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be \<2)
• Women who have tested positive for pregnancy, or are breast-feeding, or are not using a highly effective method of birth control that can be maintained for the duration of the study
• Serum hemoglobin \> 16 g/dL (males) or \> 14 g/dL (females); or platelet count \> 400,000/mm3
• Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
• Serum bilirubin \> 1.5 x ULN
• Alkaline phosphatase \> 2.5 x ULN
• AST or ALT \> 2.5 x ULN
• Creatinine \> 2.0 x ULN
• Patients with known and documented Transferrin saturation \<20% or ferritin \< 100 ng/ml
• Patients with known and documented elevated PSA levels
• Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
• Expected survival \< 1 year
• Allergy or other contraindication to hCG
• Allergy or other contraindication to epoetin alfa:

Sponsors & Collaborators

• Stem Cell Therapeutics Corp.: lead

Study Sites (2)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868-4280, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Ovidrel; Epoetin Alfa; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Steven C Cramer, MD, MMSc

  Department of Neurology, University of Califonia, Irvine Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 15, 2008
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 5, 2011

Record last verified: 2011-09

Locations

US (2)