Study 3: Minocycline Decreases Microglia Activation

NCT ID: NCT02213575

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-05
• Study Completion Date: 2018-11-01

Brief Summary

This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133872 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

Detailed Description

This study (Study 3) will recruit 9 subjects from NCT02133872 (Study1) who will agree to undergo additional autonomic testing and imaging studies at baseline and after 6 months of study treatment. Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in Montreal Canada.

For this study (Study 3) we include participants being enrolled Study 1 and/or participants who have completed participation in Study 1 and have not taken minocycline for 2 months will be approached to enroll in Study 3.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minocycline Treatment Group

Participants with neurogenic treatment-resistant hypertension who meet inclusion/exclusion criteria will receive minocycline at a dose determined to be most effective in lowering blood pressure (based on results from Study 1).

Participants will undergo brain imaging with MRI and PET at baseline and 26 weeks.

Intervention:

Drug: Minocycline Dose: 50, 100, or 200 mg/day (based on optimal BP-lowering dose from Study 1) Frequency: Administered orally twice daily (BID) Duration: 26 weeks

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and 26 week follow-up MRI and PET scans for changes in the paraventricular nucleus.

Control

Patients without a diagnosis of neurogenic (treatment-resistant) Hypertension and have not been treated with minocycline will be recruited. These participants will undergo one-time brain imaging visit (MRI and PET)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minocycline

Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and 26 week follow-up MRI and PET scans for changes in the paraventricular nucleus.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects participating in Study 1 will be eligible to participate.
• (For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized imaging of the participant's brain using magnetic resonance imaging (MRI), positron emission tomography (PET) scanning, Autonomic Nervous System Testing and blood drawing- if participant qualifies

• No diagnosis of neurogenic (treatment-resistant) hypertension.
• Not treated with minocycline.
• Willing to travel to Montreal, Canada for brain imaging and testing.
• Able to provide informed consent.

Exclusion Criteria

-Female participants with positive pregnancy test.

-Female participants with positive pregnancy test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Pepine, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Cardiovascular Clinic

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RO1HL3361028

Identifier Type: OTHER

Identifier Source: secondary_id

2013-00102 Study 3

Identifier Type: OTHER

Identifier Source: secondary_id

R01HL132448

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201500594 -N

Identifier Type: -

Identifier Source: org_study_id