NCT02113176

Brief Summary

The purpose of this study is to determine the safety and efficacy of a drug minocycline in improving outcomes at 3 months after rupture of an aneurysm in the head.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

6.9 years

First QC Date

January 31, 2014

Last Update Submit

July 17, 2025

Conditions

Subarachnoid Aneurysm Hemorrhage

Keywords

SAH

Outcome Measures

Primary Outcomes (1)

  • adverse event

    The primary objective of the study is to evaluate the effectiveness of minocycline in improving outcomes for patients after aneurysmal SAH. To determine the safety of minocycline 200mg/day for 21 days in the treatment arm after aneurysmal subarachnoid hemorrhage.

    21 days

Secondary Outcomes (1)

  • comparative stroke scale

    3 months

Study Arms (2)

Minocycline

EXPERIMENTAL

* 200 mg IV/placebo * Followed by 100 mg IV BID x 7days * Followed by 200 mg tablet QD x 14days

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

200 mg IV/placebo

Drug: Minocycline

Interventions

MinocyclineDRUG
MinocyclinePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 yrs of age
  • Ruptured aneurysm
  • Initiate treatment within 72 hours of SAH
  • Pre Rankin ≤ 1

You may not qualify if:

  • Hunt \& Hess 5 with no improvement
  • ICP \> 30
  • No plans to treat aneurysm
  • Allergy to Tetracycline / Antibiotics
  • Creatinine \>2
  • Platelets \< 75,000
  • Other brain diseases
  • Previous infection requiring Tetracycline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurosurgery & Radiology, Director of Neurosurgical Research, Director of Stroke Service

Study Record Dates

First Submitted

January 31, 2014

First Posted

April 14, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations

US(1)