Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

NCT00233090 | Terminated Phase 2 Results

• 2 other identifiers: GCO #02-0677H133A020501
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Conditions

Fatigue

Keywords

Fatigue; TBI; brain injury; Modafinil; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Self-report of fatigue

  comparison pre and post treatment

Secondary Outcomes (7)

• Cognitive Performance

  comparison pre and post treatment

• Mood

  comparison pre and post treatment

• Pain

  comparison pre and post treatment

• Sleep Quality

  comparison pre and post treatment

• Health Status

  comparison pre and post treatment

Study Arms (2)

Modafinil

EXPERIMENTAL

single dose of 200 mg. a day of modafinil for four weeks

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Modafinil DRUG

single dose of 200 mg. a day of modafinil for four weeks

Modafinil

Placebo DRUG

daily dose of placebo for four weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.

You may not qualify if:

• \- Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

MeSH Terms

Conditions

Fatigue; Brain Injuries; Brain Injuries, Traumatic

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Study was terminated due to insufficient recruitment. Data analysis not available.

Results Point of Contact

• Title: Wayne A Gordon, PhD
• Organization: Icahn School of Medicine at Mount Sinai

wayne.gordon@mssm.edu

212-659-9372

Study Officials

• Wayne A Gordon, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-03

Locations

US (1)