Back to resultsPrevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Primary Purpose
Spinal Tumors, Trauma Patients, Minocycline.
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Minocycline
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Tumors, Trauma Patients, Minocycline.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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:
Inclusion Criteria:
1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
Exclusion criteria:
1.Intramedullary tumors or tumors causing complete cord syndrome
-
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Minocycline, Spinal Tumor patients, quality of life
Minocycline, Trauma patuents, quality of life
Placebo, Trauma patients, quality of life
Placebo, Spinal cord tumors, quality of life
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01813240
First Posted
March 11, 2013
Last Updated
March 15, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01813240
Brief Title
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Tumors, Trauma Patients, Minocycline.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
444 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minocycline, Spinal Tumor patients, quality of life
Arm Type
Experimental
Arm Title
Minocycline, Trauma patuents, quality of life
Arm Type
Experimental
Arm Title
Placebo, Trauma patients, quality of life
Arm Type
Placebo Comparator
Arm Title
Placebo, Spinal cord tumors, quality of life
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
Description
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
Time Frame
six months
Secondary Outcome Measure Information:
Title
Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
Description
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
Time Frame
six months
Title
Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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:
Inclusion Criteria:
1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
Exclusion criteria:
1.Intramedullary tumors or tumors causing complete cord syndrome
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamim Drenger, Prof.
Email
drenger@ekmd.huji.ac.il
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
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