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Trial Title:
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
NCT ID:
NCT01813240
Condition:
Spinal Tumors, Trauma Patients, Minocycline.
Conditions: Official terms:
Spinal Cord Neoplasms
Spinal Neoplasms
Minocycline
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Minocycline
Arm group label:
Minocycline, Spinal Tumor patients, quality of life
Arm group label:
Minocycline, Trauma patuents, quality of life
Intervention type:
Drug
Intervention name:
placebo
Arm group label:
Placebo, Spinal cord tumors, quality of life
Arm group label:
Placebo, Trauma patients, quality of life
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?
Criteria for eligibility:
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
-
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hadassah Medical Organization
Address:
City:
Jerusalem
Country:
Israel
Start date:
May 2013
Lead sponsor:
Agency:
Hadassah Medical Organization
Agency class:
Other
Source:
Hadassah Medical Organization
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01813240
