FatiguePhase 1NCT00702637
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
A Phase 1 study testing Modafinil in people with Fatigue, run by Craig Hospital.
Trial summary
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Modafinil
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Individuals who sustained a TBI
- were discharged from Craig Hospital following initial rehabilitation
- are at least one year post-injury
- have disabling symptoms of fatigue and/or EDS which compromise their ability to function optimally
- (if female) are surgically sterile, two years post-menopausal, or if of childbearing potential, are using a medially acceptable method of birth control and agree to continue use of this method for the duration of the study
Who cannot join
- Individuals who have Neurologic and/or neuropsychiatric difficulties and/or deficits which will obscure the evaluation of this medication's effectiveness -
- have a diagnosis of other likely causes of EDS
- have concurrent medication use and/or clinically significant systemic disease that may cause fatigue and/or diminished arousal
- have epilepsy
- currently use of any anti-epileptic medications or Warfarin
- have cardiovascular disease or risks
Show all 9Show fewer
- have severe renal or hepatic impairment
- have significant psychiatric or behavioral disturbance which would obscure the evaluation of medication effectiveness
- are a pregnant or lactating female
About this study
Official title: Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.
Read the detailed description
Background: An estimated 5.3 million Americans are living with a TBI-related disability today. These persons may face many issues, however, two chronic problems seem common to a strikingly large number of those who survive TBI: fatigue and EDS.
Need for Research: Modafinil has been shown to be useful for fatigue and sleepiness in patients with depression, multiple sclerosis, Parkinson's disease and individuals with EDS secondary to a variety of sleep disturbances. However, there has not been any controlled evaluation of Modafinil use for the treatment of individuals with TBI to date.
Current and Future Research Activity: Approximately 60 participants with post-TBI fatigue will be randomly assigned to two 10-week periods of taking either Modafinil or placebo. Participants taking Modafinil during the first 10 weeks will be switched to placebo for the second 10 weeks. Similarly, participants taking placebo during the first 10 weeks will be switched to Modafinil for the second 10 weeks. Outcomes relating to fatigue and EDS will be collected weekly throughout the study. Other outcomes (including general health, depression, and cognitive function) will be collected at the start of each period, 4 weeks into each period, and again at the end of each period. It is hypothesized that participants taking Modafinil will report significantly less fatigue and EDS, report significantly better general health and depression scores, and perform significantly better on tests of cognitive performance in comparison to participants taking placebo.
- Conditions
- Fatigue
- Being tested
- Modafinil
- Keywords
- Traumatic Brain Injury, Fatigue, Modafinil, Somnolence
- Medical subject headings
- Fatigue, Brain Injuries, Traumatic, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report of fatigue
Self report of EDS
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Secondary outcomes (4)
Self report of general health
Self report of depressive symptomatology
Performance on tests of cognitive functioning
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startOct 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702637
- Sponsor's protocol ID
- H133A020510; R01
- Status last verified
- Jun 2010
- First submitted
- 18 Jun 2008
- Last updated
- 14 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00702637
- Acronym / sponsor ID
- H133A020510; R01
- Conditions
- Fatigue
- Keywords
- Traumatic Brain Injury, Fatigue, Modafinil, Somnolence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.
Detailed description
Background: An estimated 5.3 million Americans are living with a TBI-related disability today. These persons may face many issues, however, two chronic problems seem common to a strikingly large number of those who survive TBI: fatigue and EDS.
Need for Research: Modafinil has been shown to be useful for fatigue and sleepiness in patients with depression, multiple sclerosis, Parkinson's disease and individuals with EDS secondary to a variety of sleep disturbances. However, there has not been any controlled evaluation of Modafinil use for the treatment of individuals with TBI to date.
Current and Future Research Activity: Approximately 60 participants with post-TBI fatigue will be randomly assigned to two 10-week periods of taking either Modafinil or placebo. Participants taking Modafinil during the first 10 weeks will be switched to placebo for the second 10 weeks. Similarly, participants taking placebo during the first 10 weeks will be switched to Modafinil for the second 10 weeks. Outcomes relating to fatigue and EDS will be collected weekly throughout the study. Other outcomes (including general health, depression, and cognitive function) will be collected at the start of each period, 4 weeks into each period, and again at the end of each period. It is hypothesized that participants taking Modafinil will report significantly less fatigue and EDS, report significantly better general health and depression scores, and perform significantly better on tests of cognitive performance in comparison to participants taking placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who sustained a TBI
- were discharged from Craig Hospital following initial rehabilitation
- are at least one year post-injury
- have disabling symptoms of fatigue and/or EDS which compromise their ability to function optimally
- (if female) are surgically sterile, two years post-menopausal, or if of childbearing potential, are using a medially acceptable method of birth control and agree to continue use of this method for the duration of the study
Key exclusion criteria (9 listed)
- Individuals who have Neurologic and/or neuropsychiatric difficulties and/or deficits which will obscure the evaluation of this medication's effectiveness -
- have a diagnosis of other likely causes of EDS
- have concurrent medication use and/or clinically significant systemic disease that may cause fatigue and/or diminished arousal
- have epilepsy
- currently use of any anti-epileptic medications or Warfarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil | Drug | – |
Primary outcome
Self report of fatigue
Self report of EDS
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
4 secondary outcomes
Self report of general health
Self report of depressive symptomatology
Performance on tests of cognitive functioning
Data collected at baseline, 4 weeks, and 10 weeks (for both phases of crossover study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modafinil in people with Fatigue, run by Craig Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self report of fatigue. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.