Use of Minocycline in Intracerebral Hemorrhage

NCT03040128 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MITCH
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1) safety/ tolerability and (2) evaluate for clinical efficacy

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of patients with Treatment-related Adverse Effects

  Treatment-related adverse effects as noted by package insert: fever, nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury)

  day 90

Secondary Outcomes (5)

• Volume (ml) of Perihematomal Edema

  Change from baseline perihematomal edema volume to chronic (day 5-11) perihematomal edema volume

• modified Rankin score

  day 90

• Barthel Index

  day 90

• National Institutes of Health Stroke Scale Score

  day 90

• Glasgow Coma Score

  day 90

Study Arms (2)

placebo

PLACEBO COMPARATOR

normal saline infusion

Other: normal saline infusion

minocycline

EXPERIMENTAL

intravenous minocycline

Drug: Minocycline

Interventions

Minocycline DRUG

high-dose, intravenous minocycline

minocycline

normal saline infusion OTHER

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 yo
• Acute neurological deficit with corresponding ICH noted on head CT
• Glasgow Coma Scale (GCS) \> 8
• Onset of symptoms within 12 hrs
• \< 30 ml of blood noted on initial CTH (30 ml hematoma volume is a noted independent marker between good and poor clinical outcome)
• ICH score \< 3
• English/ Spanish speaking

You may not qualify if:

• Allergy to tetracycline and tetracycline analogues
• Pregnancy or suspected pregnancy
• Hepatic and/or renal insufficiency (LFTs 3x greater than upper limit of normal; creatinine \> 2 mg/dL)
• Thrombocytopenia (plt count \< 75,000)
• History of intolerance to minocycline
• Baseline modified Rankin score \> 1
• Stuporous or comatose (GCS \< 8)
• Presence of concomitant serious illness that would confound study, including serious psychiatric disease or prior suicide attempts.

Sponsors & Collaborators

• University of Tennessee: lead
• University of Southern California: collaborator

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: random number generator (placebo vs. study drug)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 2, 2017
• Study Start: June 27, 2013
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share