Trial Outcomes & Findings for A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients (NCT NCT01805895)

Results Overview

A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

90 days

Results posted on

2018-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Minocycline This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.	Control This arm will not receive any minocycline. This arm will receive standard of care treatment.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minocycline n=8 Participants This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.	Control n=8 Participants This arm will not receive any minocycline. This arm will receive standard of care treatment.	Total n=16 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 14.6 • n=5 Participants	61.8 years STANDARD_DEVIATION 11.5 • n=7 Participants	61.9 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.

Outcome measures

Outcome measures
Measure	Minocycline n=8 Participants This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.	Control n=8 Participants This arm will not receive any minocycline. This arm will receive standard of care treatment.
Modified Rankin Scale	3.5 units on a scale Standard Deviation 2.3	3.7 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 90 days

Adverse events will be asses for 90 days. This will serve as our safety endpoint.

Outcome measures

Outcome measures
Measure	Minocycline n=8 Participants This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.	Control n=8 Participants This arm will not receive any minocycline. This arm will receive standard of care treatment.
Safety Assessment	0 adverse events	0 adverse events

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jeffrey Switzer

Augusta University

Phone: 7067211691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place