Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Tumors, Trauma Patients, Minocycline.
Intervention: Minocycline (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization Overall contact: Benjamim Drenger, Prof., Email: drenger@ekmd.huji.ac.il
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:
1. Minimizing the neurological damage among trauma patients.
2. Preventing neurological damage through operation in spinal tumors patients.
2. OBJECTIVES
The primary objectives of the trial are to determine:
1. Efficacy of administrating minocycline in minimizing the neurological damage among
acute spinal cord injury patients and spinal cord tumors (primary and metastases)
patients?
2. Efficacy of administrating minocycline at changing the natural history and
rehabilitation of spinal cord trauma patients.
3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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
Secondary outcome: 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?
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations,
blunt trauma (central cord syndrome).
1. Inclusion Criteria:
2. Patients with incomplete spinal cord syndromes related to fractures, dislocations,
blunt trauma (central cord syndrome).
3. Ages: 18 to 65
4. Males - including those involved in active military duty.
5. 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:
1. Complete cord transection, severe head injury, coma, or other disease of the CNS, and
spinal injury diagnosed later than 24 hours.
2. Pregnant women (minocycline can cause fetal harm) and children.
3. Lower extremity fractures, mildly reduced consciousness and frail cognitive status
will not be considered for exclusion.
4. 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
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Locations and Contacts
Benjamim Drenger, Prof., Email: drenger@ekmd.huji.ac.il
Hadassah Medical Organization, Jerusalem, Israel; Not yet recruiting
Additional Information
Starting date: May 2013
Last updated: March 15, 2013
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