Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement

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?

Study Overview

• Status: Unknown
• Conditions: Spinal Tumors, Trauma Patients, Minocycline.
• Intervention / Treatment: Drug: placebo; Drug: Minocycline

• Study Type: Interventional
• Enrollment (Anticipated): 444
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Benjamim Drenger, Prof.; Email: drenger@ekmd.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minocycline, Spinal Tumor patients, quality of life	Drug: Minocycline
EXPERIMENTAL: Minocycline, Trauma patuents, quality of life	Drug: Minocycline
PLACEBO_COMPARATOR: Placebo, Trauma patients, quality of life	Drug: placebo
PLACEBO_COMPARATOR: Placebo, Spinal cord tumors, quality of life	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	six months

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (ESTIMATE): March 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Bone Neoplasms; Spinal Cord Neoplasms; Spinal Neoplasms; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: 0727-11-HMO