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Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

NCT00893789 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2021-12-17

Study results available
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Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Conditions

Interventions

DRUG

Armodafinil

Armodafinil 50 mg/day

DRUG

Armodafinil

Armodafinil 150 mg/day

DRUG

Armodafinil

Armodafinil 250 mg/day

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Cephalon, Inc.

    lead INDUSTRY

Principal Investigators

  • Sponsor's Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00893789 on ClinicalTrials.gov