CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Hydrogen +3 moredrug
Likely dose
Minocycline 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03320018
NCT03320018Phase 3Completed

Pilot Study of the Neuroprotective Effects of Hydrogen and Minocycline in Acute Ischemic Stroke

Stony Brook University·interventional·Posted Oct 24, 2017·Updated Dec 19, 2023

In Brief

A Phase 3 clinical trial evaluating Hydrogen, Minocycline, and 2 other interventions for Stroke, Ischemic. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This is a pilot randomized control trial (RCT) to explore the possible beneficial effect of a novel combination therapy consisting of molecular hydrogen H2 plus minocycline ("H2M"), on neurological recovery after acute ischemic stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 24, 2017
Enrollment StartAug 2, 2017
Primary CompletionAug 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago

Interventions

Hydrogendrug

Hydrogen will be infused into bags of normal saline solution and administered intravenously, or hydrogen generating tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.

Minocyclinedrug

Minocycline 200 mg will be mixed with normal saline and given by i.v. administration, or provided as capsules for the patient to swallow, q 24 hours for 5 days. Once patients regain the ability to swallow capsules, minocycline will be given orally in capsule form (2 capsules of 100 mg each), administered once daily for the remainder of the 5 day period.

Placebo Hydrogenother

Normal saline solution will be administered intravenously, in place of hydrogen solution. Placebo tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.

Placebo Minocyclineother

Normal saline solution or placebo capsule will be administered i.v. or p.o. respectively, in place of minocycline.