SarcoidosisPhase 2/3NCT00555347
Use of Armodafinil for Fatigue in Sarcoidosis
A Phase 2/3 study testing Armodafinil in people with Sarcoidosis and Fatigue, run by University of Cincinnati at 1 site in United States.
Trial summary
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Fatigue, Sleepiness
- What is being tested?
- Armodafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of sarcoidosis using standard criteria 15.
- Disease for more than one year
- On stable, systemic therapy
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
- Provide written informed consent.
Who cannot join
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- History of ventricular arrythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Read the detailed description
The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.
Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.
They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.
- Conditions
- Sarcoidosis, Fatigue, Sleepiness
- Being tested
- Armodafinil, Placebo
- Keywords
- Sarcoidosis, Fatigue
- Medical subject headings
- Sarcoidosis, Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil
Dosage 150-250 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Armnodafinil | Active comparator | Armodafinil Receives: Drug: Armodafinil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Measured: Prospective
Secondary outcomes (2)
To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.
Measured: Prospective
To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert P Baughman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555347
- Sponsor's protocol ID
- IRB 07011901
- Status last verified
- Apr 2013
- First submitted
- 7 Nov 2007
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
- ClinicalTrials.gov ID
- NCT00555347
- Acronym / sponsor ID
- IRB 07011901
- Conditions
- Sarcoidosis, Fatigue, Sleepiness
- Keywords
- Sarcoidosis, Fatigue
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Nov 2007 (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.
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Detailed description
The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.
Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.
They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armnodafinil | Active comparator | Drug: ArmodafinilArmodafinil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of sarcoidosis using standard criteria 15.
- Disease for more than one year
- On stable, systemic therapy
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
Key exclusion criteria (3 listed)
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- History of ventricular arrythmias
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 |
|---|---|---|
| ArmodafinilAlso: NuvigilDosage 150-250 mg | Drug | Armnodafinil |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Time frame: Prospective
2 secondary outcomes
To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.
Time frame: Prospective
To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.
Time frame: Prospective
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 27 May 2015.
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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.
Robert P Baughman, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Armodafinil in people with Sarcoidosis and Fatigue, run by University of Cincinnati at 1 site in United States.
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 6 inclusion and 3 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. (time frame: Prospective). 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 27 May 2015.