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StrokePhase 1NCT02178813

The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization

A Phase 1 study testing Administration of minocycline in people with Stroke, run by University of Pittsburgh at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline in the patient population undergoing carotid revascularization procedures, namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will facilitate proceeding to a phase II trial. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke
What is being tested?
Administration of minocycline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jul 2014to Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a clinical indication for carotid revascularization (CRV) as decided by the treating physicians (the clinical indications for CRV as well as the choice of the type of CRV, either CEA or CAS, will be entirely up to the treating physicians)
  • Patients who can perform the neurocognitive tests in English
  • Women of childbearing age who are non-lactating and have a negative pregnancy test
  • Patients in the age range of 18 years - 90 years
  • Patients able to undergo MRI imaging.
  • Patients that are dependable and able to return for follow-up studies and exams.
  • Patients that will be in the hospital (inpatients) the day prior to the procedure for clinical purposes (for evaluation of side effects from the first dose and for overnight infusion of minocycline before the procedure)

Who cannot join

  • Known hypersensitivity to tetracyclines
  • Significant neurological deficit including but not limited to dense aphasia, hemi- or mono-paresis (motor strength equal or less than 3/5) or neglect.
  • Baseline abnormalities on the MRI of the brain which would preclude the detection of new DWI or FLAIR changes. (e.g large areas of acute stroke, large areas of previous encephalomalacia, existing hardware such as aneurysm clips or coil masses etc.)
  • Patients who are pregnant, breast-feeding, or lactating.
  • Patients with a contraindication to undergo MRI, including those with pacemakers, metal implants and metal fragments within their bodies.
  • Patients with abnormal liver function tests at baseline defined as a 2-fold elevation in alanine-aminotransferase.
Show all 13Show fewer
  • Patients with significantly affected renal function at baseline (Creatinine equal or above 2mg/dL).
  • Patients on high dose isotretinoin, vitamin A, or methotrexate
  • Patients undergoing emergency carotid revascularization procedures.
  • Any clinically important known medical, surgical, psychiatric or psychological disease, which would preclude completion of the protocol (such as advanced cardiac, renal or pulmonary disease).We will screen for physical and mental capacity to undergo study procedures and will obtain proxy consent for subjects who appear decisionally impaired. The screening process will be performed by the physician co-investigator obtaining the informed consent.
  • Patients with a Mini-Mental Status Exam score (MMSE) of less than 21 (as determined by one of the co-investigators). Patients with MMSE score of 21 will be included.
  • Patients undergoing carotid revascularization in less than 36 hours from identification, or patients who are undecided about participation less than 36 hours prior to the procedure will not be eligible for the study.
  • Patients with any other factor that would make follow-up studies difficult (e.g patient is from another country, or patient is a prisoner)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15206

Other trials in United States

About this study

Official title: The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization. A Phase I Study

The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline in the patient population undergoing carotid revascularization procedures, namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will facilitate proceeding to a phase II trial.

During this trial, patients undergoing carotid revascularization procedures will receive high doses of minocycline with the following schedule (based on previous trials):

Read more
  • Day prior to procedure: 800mg orally (p.o), 700mg p.o.
  • Day of procedure: 600mg intravenously( i.v.), 500mg p.o.
  • Day after procedure: 400mg p.o., 400mg p.o.

The levels of the drug in the plasma, standard blood tests (complete blood count, creatinine, liver function tests) as well as markers of neuronal injury (Neuron specific enolase, protein- S100b) and inflammation (C-reactive protein) will also be monitored. The patients will be monitored closely for the development of side effects from minocycline.

MRI imaging will be used to follow the development of small strokes as a result of the revascularization procedures and their resolution. The patients of this study, all receiving peri-operative minocycline, will be compared with historical controls with regards to development of small strokes and persistent of these strokes on subsequent MRI imaging.

Conditions
Stroke
Being tested
Administration of minocycline
Keywords
Minocycline, Neuroprotection, Stroke
Medical subject headings
Stroke, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of minocyclineDrug

    Also called Minocycline (generic name)

    Administration of minocycline with the following schedule:

    • Day prior to procedure: 800mg p.o., 700mg p.o.
    • Day of procedure: 600mg i.v., 500mg p.o.
    • Day after procedure: 400mg p.o., 400mg p.o.
Study groups in NCT02178813
Study groupRoleWhat they receive
Administration of minocyclineExperimentalAll patients in the study will receive minocycline periprocedurally with the following schedule: * Day prior to procedure: 800mg p.o., 700mg p.o. * Day of procedure: 600mg i.v., 500mg p.o. * Day after procedure: 400mg p.o., 400mg p.o.
Receives: Drug: Administration of minocycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug Safety/Tolerability (Number of patients that require discontinuation of drug because of side effects)

    The primary aim of this phase I study is to establish the safety and tolerability of this drug in patient population undergoing carotid revascularization procedures by monitoring complete blood counts, liver enzymes, renal function tests, and clinical side effects

    During the above time frame (one day prior to procedure until 1 day after the procedure) the number of patients that develop any side effects requiring discontinuation of the drug will be noted.

    Side effects that will lead to discontinuation of the drug are the following:

    • The patient reports a clinical side effect as intolerable (nausea /vomiting, dysphagia, rash, vertigo or other side effects attributable to the administration of minocycline)
    • Change in liver function tests ( 2 times elevation of alanine-aminotransferase above the normal range)
    • Change in renal function tests (creatinine more than 1.5 points from baseline)

    Measured: One day prior to procedure to 1 days after procedure

Secondary outcomes (4)

  1. Progression of procedural stroke on MRI imaging

    Secondary Aim 1:To examine the effect of perioperative treatment with minocycline on the number and overall volume of new neurologic ischemic lesions detected by Diffusion Weighted Imaging (DWI) within 24 hours following carotid revascularization, and on the conversion of these acute lesions to persistent changes on Magnetic Resonance Imaging (MRI) fluid-attenuated inversion recovery (FLAIR) sequences. The findings in the study's cohort of patients will be compared to historical controls

    Measured: 10 days before procedure, 1 day after procedure, 1 month after procedure

  2. Neuropsychological test performance

    To examine the effect of perioperative minocycline on neuropsychological test performance. The findings in the study's cohort of patients will be compared to historical controls

    Measured: 10 days prior to procedure, 1 day after procedure, 1 month after procedure

  3. Myocardial Infarction

    To examine the effect of preoperative minocycline on the incidence of myocardial infarction during carotid revascularization procedures. The findings in the study's cohort of patients will be compared to historical controls. Myocardial infarction will be investigated based on clinical grounds, electrocardiographic findings, and elevation of troponins.

    Measured: Days 1, 2(procedure day), 3

  4. Markers of neuronal injury

    To examine the effect of perioperative minocycline on markers of neuronal injury (Neuron Specific Enolase and S100b) as well as inflammation C- reactive protein). The findings in the study's cohort of patients will be compared to historical controls

    Measured: 1 day prior to procedure, 1 day after the procedure, 1 month after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: Study stopped prematurely because of multiple logistic difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178813
Sponsor's protocol ID
PRO13120002
Status last verified
Jun 2017
First submitted
23 Jun 2014
Last updated
9 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Casha S, Zygun D, McGowan MD, Bains I, Yong VW, Hurlbert RJ. Results of a phase II placebo-controlled randomized trial of minocycline in acute spinal cord injury. Brain. 2012 Apr;135(Pt 4):1224-36. doi: 10.1093/brain/aws072.

    PubMed 22505632

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Administration of minocycline in people with Stroke, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped prematurely because of multiple logistic difficulties). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug Safety/Tolerability (Number of patients that require discontinuation of drug because of side effects) (time frame: One day prior to procedure to 1 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02178813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.

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