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

What Was Tested

This registered phase 2 trial tested hCG (human chorionic gonadotropin).

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.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Saline Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 96 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: NIHSS score 8-20. Stroke is ischemic in origin, supratentorial, and radiologically confirmed. Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated.

The full record lists 7 inclusion and 22 exclusion criteria; among the exclusions: patients presenting with lacunar, hemorrhagic and/or brain stem stroke; patients who have received tissue plasminogen activator (tpa)following the index stroke; patients classified as comatose.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-08 with completion listed for 2010-04.

It ran at 23 sites in India (18), Canada (4) and United States (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 (time frame: Baseline and Day 90).

It also tracked 11 secondary outcomes, for example NIHSS Response >=4 at Day 90, NIHSS Change From Baseline at Day 30, Modified Rankin Scale (mRS) Response <=2 at Day 90, Barthel Index at Day 90, Action Research Arm Test (ARAT) Change From Baseline at Day 90 and Gait Velocity Test Change From Baseline at Day 90.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) in 96 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.