Spinal Tumors, Trauma Patients, Minocycline.Phase 2/3NCT01813240
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
A Phase 2/3 study testing Minocycline in people with Spinal Tumors, Trauma Patients, Minocycline., run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Tumors, Trauma Patients, Minocycline.
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Apr 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Inclusion Criteria:
- Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Ages: 18 to 65
- Males - including those involved in active military duty.
- Females - of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Pregnant women will be excluded from the study.
- 1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
Who cannot join
- Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours.
- Pregnant women (minocycline can cause fetal harm) and children.
- Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion.
- Patients who will not be enrolled will be listed and reason for non inclusion will be recorded.
- Spinal tumors:
- 1.Intramedullary tumors or tumors causing complete cord syndrome
- -
Trial locations and contacts
1 site in 1 country.
Benjamim Drenger, Prof. contact
About this study
Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups:
- Minimizing the neurological damage among trauma patients.
- Preventing neurological damage through operation in spinal tumors patients.
Read more
2.OBJECTIVES
The primary objectives of the trial are to determine:
- Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients?
- Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
- Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
- Being tested
- Minocycline, placebo
- Medical subject headings
- Spinal Cord Neoplasms, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Minocycline, Spinal Tumor patients, quality of life | Experimental | Not described Receives: Drug: Minocycline |
| Minocycline, Trauma patuents, quality of life | Experimental | Not described Receives: Drug: Minocycline |
| Placebo, Trauma patients, quality of life | Placebo comparator | Not described Receives: Drug: placebo |
| Placebo, Spinal cord tumors, quality of life | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
The Efficacy will be evaluated using the following measures:
- ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint.
- The Spinal Cord Independence Measure and Functional Independence Measure outcome scales.
- Objective reduction in lesion size by imaging modalities
Measured: six months
Secondary outcomes (2)
Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
The Efficacy will be evaluated using the following measures:
- ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint.
- The Spinal Cord Independence Measure and Functional Independence Measure outcome scales.
- Objective reduction in lesion size by imaging modalities
Measured: six months
Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity.
The study will evaluate safety by assessing:
- Procedure related adverse events:
- General adverse events: Adverse events not only directly related to the procedure, such as: complications related to anesthesia, hospitalization, or other general adverse events of unknown cause.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Tumors, Trauma Patients, Minocycline.Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Drenger, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813240
- Sponsor's protocol ID
- 0727-11-HMO
- Status last verified
- Mar 2013
- First submitted
- 11 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
- ClinicalTrials.gov ID
- NCT01813240
- Acronym / sponsor ID
- 0727-11-HMO
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 18 Mar 2013 (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.
Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups:
- Minimizing the neurological damage among trauma patients.
- Preventing neurological damage through operation in spinal tumors patients.
2.OBJECTIVES
The primary objectives of the trial are to determine:
- Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients?
- Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
- Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minocycline, Spinal Tumor patients, quality of life | Experimental | Drug: Minocycline |
| Minocycline, Trauma patuents, quality of life | Experimental | Drug: Minocycline |
| Placebo, Trauma patients, quality of life | Placebo comparator | Drug: placebo |
| Placebo, Spinal cord tumors, quality of life | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Inclusion Criteria:
- Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Ages: 18 to 65
- Males - including those involved in active military duty.
Key exclusion criteria (7 listed)
- Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours.
- Pregnant women (minocycline can cause fetal harm) and children.
- Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion.
- Patients who will not be enrolled will be listed and reason for non inclusion will be recorded.
- 1.Intramedullary tumors or tumors causing complete cord syndrome
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 |
|---|---|---|
| Minocycline | Drug | Minocycline, Spinal Tumor patients, quality of life, Minocycline, Trauma patuents, quality of life |
| placebo | Drug | Placebo, Spinal cord tumors, quality of life, Placebo, Trauma patients, quality of life |
Primary outcome
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
Time frame: six months
The Efficacy will be evaluated using the following measures: 1. ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint. 2. The Spinal Cord Independence Measure and Functional Independence Measure outcome scales. 3. Objective reduction in lesion size by imaging modalities
2 secondary outcomes
Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
Time frame: six months
Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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.
Benjamim Drenger, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Minocycline in people with Spinal Tumors, Trauma Patients, Minocycline., run by Hadassah Medical Organization at 1 site in Israel.
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 7 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 18 Mar 2013. 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 Israel. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Benjamim Drenger, Prof. (drenger@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients (time frame: six months). 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 18 Mar 2013.