StrokePhase 1NCT01556802
Use of Minocicline in Patients With Stroke
A Phase 1 study testing Minocicline in people with Stroke and Brain Ischemia, run by Hospital Universitario Hernando Moncaleano Perdomo at 1 site in Colombia.
Trial summary
The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Brain Ischemia, Paralysis
- What is being tested?
- Minocicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2011to Jan 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIHSS scale greater than 5
- Onset of symptoms less than 24 hours
- normal Cranial Tomography(CT)
- CT evidence of cerebral ischemia
- Acceptance of study entry
Who cannot join
- Hemorrhagic cerebrovascular disease
- Other neurological diseases
- Concomitant structural damage
- History of neurosurgery
- Known allergy to tetracyclines
- Concomitant infectious diseases requiring antibiotic treatment.
- History of Stroke
- Women pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
Nataly Bedoya, md contact
Colombia1 site, 1 recruiting
- Recruiting
University Hospital hernando Moncaleano Perdomo
Neiva, Huila Department
Nataly Bedoya, Md., nata0916@hotmail.com
About this study
Official title: Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke
The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.
- Conditions
- Stroke, Brain Ischemia, Paralysis
- Being tested
- Minocicline, Placebo
- Keywords
- stroke, sequelaes, minocicline
- Medical subject headings
- Stroke, Brain Ischemia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinociclineDrug
Minocicline 100mg oral twice a day for 5 days
PlaceboDrug
Pills with vegetable fibers one pill oral twice a day for five days
| Study group | Role | What they receive |
|---|---|---|
| Minocicline | Experimental | minocicline 100mg oral twice a day for 5 days Receives: Drug: Minocicline |
| Placebo | Placebo comparator | Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed.
Measured: one year
Secondary outcomes (1)
Identify the side effects of the intervention administered during the treatment time and 30 days later.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Hernando Moncaleano Perdomo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo
- Investigators
- Nataly Bedoya, Internist, Study director, Universidad SurcolombianaHernan Vargas, Internist, Principal investigator, Universidad SurcolombianaHugo Osorio, Internist, Principal investigator, Universidad SurcolombianaGuillermo Gonzalez, Neurologist, Principal investigator, Universidad SurcolombianaJavier Saldaña, Epidemiology, Principal investigator, Universidad SurcolombianaEfrain Amaya, Neurologist, Principal investigator, Hospital Hernando Moncaleano Perdomo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556802
- Sponsor's protocol ID
- 38212050
- Status last verified
- Mar 2012
- First submitted
- 5 Mar 2012
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke
- ClinicalTrials.gov ID
- NCT01556802
- Acronym / sponsor ID
- 38212050
- Conditions
- Stroke, Brain Ischemia, Paralysis
- Keywords
- stroke, sequelaes, minocicline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Hospital Universitario Hernando Moncaleano PerdomoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2013 (estimated)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocicline | Experimental | Drug: Minociclineminocicline 100mg oral twice a day for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NIHSS scale greater than 5
- Onset of symptoms less than 24 hours
- normal Cranial Tomography(CT)
- CT evidence of cerebral ischemia
- Acceptance of study entry
Key exclusion criteria (8 listed)
- Hemorrhagic cerebrovascular disease
- Other neurological diseases
- Concomitant structural damage
- History of neurosurgery
- Known allergy to tetracyclines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinociclineMinocicline 100mg oral twice a day for 5 days | Drug | Minocicline |
| PlaceboPills with vegetable fibers one pill oral twice a day for five days | Drug | Placebo |
Primary outcome
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
Time frame: one year
The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed.
1 secondary outcome
Identify the side effects of the intervention administered during the treatment time and 30 days later.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nataly Bedoya, md contact
Nataly Bedoya, Internist study director
Universidad Surcolombiana
Hernan Vargas, Internist principal investigator
Universidad Surcolombiana
Hugo Osorio, Internist principal investigator
Universidad Surcolombiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocicline in people with Stroke and Brain Ischemia, run by Hospital Universitario Hernando Moncaleano Perdomo at 1 site in Colombia.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Mar 2012. 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 Colombia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nataly Bedoya, md (nata0916@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2012.