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Phase 2/Phase 3
18 Years
65 Years
Not Enrolling
Both
Spinal Tumors, Trauma Patients, Minocycline.

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Trial Information


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

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

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

Outcome 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

Outcome Time Frame:

six months

Safety Issue:

No

Authority:

Israel: Ministry of Health

Study ID:

0727-11-HMO

NCT ID:

NCT01813240

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Spinal Tumors, Trauma Patients, Minocycline.
  • Spinal Cord Injuries
  • Spinal Cord Neoplasms
  • Spinal Neoplasms
  • Wounds and Injuries

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