Multiple SclerosisPhase 2/3NCT00981084

Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)

A Phase 2/3 study testing armodafinil in people with Multiple Sclerosis, run by University of Missouri, Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: armodafinil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Apr 2011
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

relapsing remitting and secondary progressive MS patients
between the ages of 18 and 60
report cognitive difficulties.
perform 1 sd or more below cut-off on cognitive screening measure

Who cannot join

no history of alcohol/drug abuse or nervous system disorder other than MS
no sensory impairments that might interfere significantly with cognitive testing
no developmental history of learning disability or attention-deficit/hyperactivity disorder
no medical condition other than MS that could substantially affect cognition
no relapse and/or corticosteroid use within four weeks of assessment;
no current use of modafinil, armodafinil or other psychostimulants.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study

The investigation will involve a double-blind, placebo controlled, cross-over study examining the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1 standard deviation below the mean on a brief cognitive screen will be given a thorough neuropsychological evaluation at two time points. Half of the patients will be randomized to receive a single oral dose of lactose placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.

Conditions: Multiple Sclerosis
Being tested: armodafinil
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

armodafinilDrug
Also called NuVigil
Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.

Study groups in NCT00981084
Study group	Role	What they receive
armodafinil and placebo	Experimental	All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design Receives: Drug: armodafinil

What is being measured

The primary outcome is the main question the study is designed to answer.

Learning and Memory Measures.
Testing was completed after first intervention and again after second intervention.
Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).
RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).
Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).
BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12).
Measured: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
CPT -Test of Information Processing Speed
Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.
Continuous Performance Test (CPT) - Vigilance and reaction time.
Measured: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Stroop
Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Measured: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Word Generation
Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Measured: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Apr 2011

First posted22 Sep 2009 (estimated)
Study startSep 2009
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple SclerosisStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00981084
Sponsor's protocol ID: C10953/6113
Status last verified: Aug 2013
First submitted: 18 Sep 2009
Last updated: 14 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study
ClinicalTrials.gov ID: NCT00981084
Acronym / sponsor ID: C10953/6113
Conditions: Multiple Sclerosis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University of Missouri, Kansas CityUniversity, hospital or other
Collaborators: University of Kansas
Study start: Sep 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 22 Sep 2009 (estimated)
Results: Posted 14 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
armodafinil and placebo	Experimental	Drug: armodafinilAll participants will receive one dose of armodafinil and one dose of placebo in a cross-over design

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

relapsing remitting and secondary progressive MS patients
between the ages of 18 and 60
report cognitive difficulties.
perform 1 sd or more below cut-off on cognitive screening measure

Key exclusion criteria (6 listed)

no history of alcohol/drug abuse or nervous system disorder other than MS
no sensory impairments that might interfere significantly with cognitive testing
no developmental history of learning disability or attention-deficit/hyperactivity disorder
no medical condition other than MS that could substantially affect cognition
no relapse and/or corticosteroid use within four weeks of assessment;

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: NuVigilHalf of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.	Drug	armodafinil and placebo

Primary outcome

Learning and Memory Measures.
Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12).
CPT -Test of Information Processing Speed
Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time.
Stroop
Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Word Generation
Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.

Results and safety

Results posted to the registry on 14 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Armodafinil First and Placebo Second	16	16
Placebo First and Armodafinil Second	17	17

Primary outcome: Learning and Memory Measures.

Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.. Mean (Standard Deviation). Unit: Items recalled

Measure	Placebo/Armofafinil n = 16	Armodafinil/Placebo n = 14
Auditory Verbal Learning Test - Learning	-3.38 (7.32)	-.07 (6.06)
Aditory Verbal Learning Test Delay	-1.38 (1.89)	1.93 (2.70)
Brief Visuospatial Memory Test Learning	.88 (4.63)	-1.57 (5.71)
Brief Visuospatial Memory Test Delay	.56 (1.50)	-.57 (2.17)

Placebo/Armofafinil vs Armodafinil/Placebo: p = .19, t-test, 2 sided
Placebo/Armofafinil vs Armodafinil/Placebo: p = .0005, t-test, 2 sided
Placebo/Armofafinil vs Armodafinil/Placebo: p = .21, t-test, 2 sided

Primary outcome: CPT -Test of Information Processing Speed

Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.. Mean (Standard Deviation). Unit: milliseconds

Measure	Placebo/Armofafinil n = 16	Armodafinil/Placebo n = 14
Value	-1.18 (37.62)	15.04 (50.30)

Placebo/Armofafinil vs Armodafinil/Placebo: p = .33, t-test, 2 sided

Primary outcome: Stroop

Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.. Mean (Standard Deviation). Unit: number of colors named

Measure	Placebo/Armofafinil n = 16	Armodafinil/Placebo n = 14
Value	-1.69 (3.38)	-2.86 (3.72)

Placebo/Armofafinil vs Armodafinil/Placebo: p = .37, t-test, 2 sided

Primary outcome: Word Generation

Time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.. Mean (Standard Deviation). Unit: number of words generated

Measure	Placebo/Armofafinil n = 16	Armodafinil/Placebo n = 14
Value	-.69 (5.21)	-1.71 (3.24)

Placebo/Armofafinil vs Armodafinil/Placebo: p = .53, t-test, 2 sided

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Then Armodafinil (Placebo)	0 of 17 (0%)	2 of 17 (11.8%)	Not reported
Armodafinil Then Placebo (Armodafinil)	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Placebo Then Armodafinil (Armodafinil)	0 of 17 (0%)	2 of 17 (11.8%)	Not reported
Armodafinil Then Placebo (Placebo)	0 of 16 (0%)	1 of 16 (6.3%)	Not reported

Limitations and caveats (from the sponsor): A small pilot trial with only one dose of drug administered. Limitations include the very small sample and the use of a single-dose cross-over design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jared M Bruce, PhD principal investigator

University of Missouri, Kansas City

Sharon Lynch, MD principal investigator

University of Kansas Medical Center

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 Multiple Sclerosis, run by University of Missouri, Kansas City 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 4 inclusion and 6 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 Oct 2013. 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. 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?

Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Learning and Memory Measures. (time frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00981084.

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 Oct 2013.