NCT01813240

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:

  1. 1.Minimizing the neurological damage among trauma patients.
  2. 2.Preventing neurological damage through operation in spinal tumors patients.
  3. 3.Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients?
  4. 4.Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
  5. 5.Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

March 11, 2013

Last Update Submit

March 15, 2013

Conditions

Spinal Tumors, Trauma Patients, Minocycline.

Outcome Measures

Primary Outcomes (1)

  • 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: 1. 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. 2. The Spinal Cord Independence Measure and Functional Independence Measure outcome scales. 3. Objective reduction in lesion size by imaging modalities

    six months

Secondary Outcomes (2)

  • Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.

    six months

  • Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?

    six months

Study Arms (4)

Minocycline, Spinal Tumor patients, quality of life

EXPERIMENTAL
Drug: Minocycline

Minocycline, Trauma patuents, quality of life

EXPERIMENTAL
Drug: Minocycline

Placebo, Trauma patients, quality of life

PLACEBO COMPARATOR
Drug: placebo

Placebo, Spinal cord tumors, quality of life

PLACEBO COMPARATOR
Drug: placebo

Interventions

MinocyclineDRUG
Minocycline, Spinal Tumor patients, quality of lifeMinocycline, Trauma patuents, quality of life
placeboDRUG
Placebo, Spinal cord tumors, quality of lifePlacebo, Trauma patients, quality of life

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
  • 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.

You may not qualify if:

  • 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.
  • Spinal tumors:
  • \. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
  • Intramedullary tumors or tumors causing complete cord syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Spinal Cord Neoplasmscyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Central Study Contacts

Benjamim Drenger, Prof.

CONTACT

drenger@ekmd.huji.ac.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia, Director, Orthopedic Anesthesia,

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 18, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2015

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

IL(1)