NCT00822263

Brief Summary

The administration of N-acetyl-cysteine (an anti-oxidant) for seven days along with observation will result in improved hearing and balance function in individuals who demonstrate these disorders after blast exposure when compared to a placebo medicine and observation at the seven day time point.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 10, 2010

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 13, 2009

Last Update Submit

August 9, 2010

Conditions

Mild Traumatic Brain Injury

Keywords

mild traumatic brain injuryanti-oxidantearly treatment

Outcome Measures

Primary Outcomes (1)

  • Relief of symptoms of mTBI

    7 days

Study Arms (2)

2

PLACEBO COMPARATOR

control

Drug: Placebo

1

EXPERIMENTAL

Active medicine

Drug: N-acetyl-cysteine (NAC)

Interventions

N-acetyl-cysteine (NAC)DRUG

Anti-oxidant in a pill format

1
PlaceboDRUG

Control for study

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be active duty United States Service member
  • Be between the ages of 18 and 50 years
  • Present to TQ Surgical within 24 hours of blast exposure.
  • Have complains consistent with possible TBI including hearing loss, dizziness, lightheadedness, cognitive difficulties, and/or had loss of consciousness.
  • Are not expressly excluded by the criteria listed below.

You may not qualify if:

  • Require urgent or emergent surgical procedures.
  • Will require medical evacuation to any level III or higher facility (other then to a level III for a CT scan only).
  • Has evidence of an open head wound.
  • Pregnant Females
  • The use, within the last seven days, of a nutritional supplement containing an anti-oxidant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TQ Surgical

AL Taqaddum, Iraq

Location

Related Publications (1)

  • Hoffer ME, Balaban C, Slade MD, Tsao JW, Hoffer B. Amelioration of acute sequelae of blast induced mild traumatic brain injury by N-acetyl cysteine: a double-blind, placebo controlled study. PLoS One. 2013;8(1):e54163. doi: 10.1371/journal.pone.0054163. Epub 2013 Jan 23.

    PMID: 23372680DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael E. Hoffer, M.D.

    U.S. Military

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

August 10, 2010

Record last verified: 2009-01

Locations

IR(1)