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TERMINATEDPHASE3

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

A 12-Month, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil (150 and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

NCT00983437•Cephalon, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients enrolled in this study will be rollover patients (those who completed the previous double-blind efficacy study C10953/3067/ES/MN) and new patients (those who did not participate in the C10953/3067/ES/MN study).
•The patient has a mild (Glasgow Coma Scale \[GCS\] score = 13-15) or moderate (GCS score = 9-12) closed traumatic brain injury (TBI) at the time of the injury, and the injury occurred 1 to 10 years prior to screening.
•The patient has a Glasgow Outcome Scale score of 5.
•The patient has an Epworth Sleepiness Scale (ESS) score of at least 10.
•The patient has a mean sleep latency on the Multiple Sleep Latency Test (MSLT) (average of 4 naps) of less than 8 minutes.
•The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating relating to their excessive sleepiness of 4 or more.
•The patient has a complaint of excessive sleepiness (at least 5 days/week on average) for at least 3 months, and the excessive sleepiness began within 12 months of the TBI identified according to the first inclusion criterion.
•Written informed consent was obtained.
•If admitted to an in-patient treatment facility, the patient was discharged at least 1 month prior to the screening visit.
•The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
+13 more criteria

Exclusion Criteria

•The patient has a history of 2 or more episodes of transient loss of consciousness without clear medical explanation, or has a history of known or suspected pseudo seizure (psychogenic seizure). Patients with a history of seizure or epilepsy may be eligible following discussion with the medical monitor.
•The patient requires, or is likely to require, treatment with anticonvulsant medication during the study; or has taken anticonvulsant medication within 6 months before the screening visit.
•The patient has an unstable or uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated) or was not a suitable candidate for treatment with armodafinil, as judged by the investigator.
•The patient has had neurosurgery involving the brain or brainstem.
•The patient has a history of schizophrenia, bipolar disorder, psychotic depression, or other psychotic episode.
•The patient has any current Axis I disorder (including depression and posttraumatic stress disorder \[PTSD\]), as assessed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (SCID). Patients with any Axis II disorder, that in the opinion of the investigator, would affect patient participation in the study or full compliance with study procedures.
•The patient has a history of, or currently meets The International Classification of Sleep Disorders, Edition 2 (ICSD-2) criteria for any other sleep disorder associated with excessive daytime sleepiness; or the patient has a history of idiopathic hypersomnia, insomnia (requiring treatment), or sleep disorder before the development of the TBI.
•The patient has 85% or less sleep efficiency (sleep duration ÷ time in bed x 100%) as determined from Nocturnal Polysomnography (NPSG).
•The patient has any disorder that may have interfered with drug absorption, distribution, metabolism, or excretion.
•The patient has used any medications including over-the-counter (OTC) medicines disallowed by the protocol within 7 days or 5 half-lives (medication or its active metabolites), whichever is longer.
+26 more criteria

Locations (61)

Teva Investigational Site 58

Birmingham, Alabama, United States

Teva Investigational Site 62

Tucson, Arizona, United States

Teva Investigational Site 16

Hot Springs, Arkansas, United States

Teva Investigational Site 5

Little Rock, Arkansas, United States

Teva Investigational Site 44

Fountain Valley, California, United States

Teva Investigational Site 49

La Palma, California, United States

Teva Investigational Site 51

La Palma, California, United States

Teva Investigational Site 55

San Diego, California, United States

Teva Investigational Site 33

San Diego, California, United States

Teva Investigational Site 53

Santa Monica, California, United States

Key Dates

Start Date

August 31, 2009

Primary Completion Date

January 31, 2011

Completion Date

January 31, 2011

Last Updated

December 17, 2021

Enrollment

ACTUAL participants

Conditions

Traumatic Brain Injury

Interventions

Armodafinil

DRUG

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

NCT04521881

Traumatic Brain Injury

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RECRUITING

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

NCT07455136

Traumatic Brain Injury

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RECRUITING

Hemodynamic ABI Monitor

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Carbon Dioxide Administration and Brain Waste Clearance

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury