Relapsing-Remitting Multiple SclerosisNCT00210301
Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
A study testing Provigil (modafinil) in people with Relapsing-Remitting Multiple Sclerosis, run by Institute for Clinical Research at 1 site in United States.
Trial summary
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Provigil (modafinil)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to not given
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients entering the study will:
- Be taking Avonex
- Have normal laboratory blood tests and EKG
- Be complaining of attention problems to treating neurologist
- Be English-speaking males and females between the ages of 25 and 60, inclusive [If patient is female, she must
- Be surgically sterile; or
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- Be 2 years postmenopausal; or
- If of child-bearing potential, must be using a medically accepted method of birth control and agree to continue to use this method for the duration of the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], IUD, or abstinence)]
- Have clinically definite RR MS with disease duration of less than 10 years
- Have an EDSS score between 0 and 5.5
- Have corrected vision of no worse than 20/50
- Have between 10 and 20 years of education
- Be cerebral-stimulant free for at least one week prior to Attention Screening
- Be able to complete self-rating scales and cognitive assessment tools
- Have provided written informed consent
- To have performed at least one standard deviation below normative expectation on at least two of four measures in the attention screening evaluation
Who cannot join
- Patients entering the study will NOT:
- A history of heart disease or liver dysfunction
- Have abnormal EKG or laboratory blood work,
- Have a history of psychosis
- Be a significant risk of suicide
- Be abusing alcohol (current and within last 2 years)
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- Be abusing controlled substances (current and within last 2 years)
- Have any medical ailment which can produce fatigue, such as lupus, anemia or thyroid disease
- Have any history of clinical deviation from normal ranges in the physical examination
- Have an unstable medical disorder, or medical contraindication to the use of Provigil
- Have any history of head injury, seizures, or neurological conditions involving the central nervous system other than RR MS
- Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion, including gastrointestinal surgery
- Be a pregnant or lactating female (any patient becoming pregnant during the study will be discontinued)
- Have received any investigational product within 30 days of Cognitive Screening
- Have upper extremity dysfunction that prohibits them from using a computer mouse writing with a pencil
- Be colorblind
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
Jeffrey A Wilken, Ph.D., 202-745-8000 ext. 7251, jeffrey.wilken@med.va.gov
Cynthia L Sullivan, Ph.D., 202-745-8000 ext. 7254, Cynthia.Sullivan@med.va.gov
About this study
Official title: Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.
Read the detailed description
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. Although certain immunomodulatory treatments may slow the progression of cogntiive difficulties, they are not therapy for the progression of or new onset of such problems. Therefore, in order to treat such problems, it is likely that adjunctive medications focused on fatigue and cognition are needed. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.
Study Period: 6 to 12-month competitive enrollment period, two groups (Avonex and Avonex +Provigil 200 mg QD ) undergo baseline (prior to starting Provigil), 2-month, and 4-month neuropsychological evaluations. Total length of study, once initiated, (including 2 month preparation period, 6 to 12-month competitive enrollment period through final four-month visit) is 12 to 18 months.
Primary Objective: To investigate whether Provigil in combination with Avonex is safe, and tolerable in patients with RRMS.
Secondary Objectives:
- To determine whether Provigil (modafinil) in combination with Avonex(interferon β-1a) is useful in treating deficits in attention, as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether combination therapy (Avonex +Provigil) favorably impacts other domains of cognition that are reliant on attention (e.g., memory, psychomotor functioning), as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Provigil (modafinil)
- Keywords
- MS, cognition, attention, fatigue
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provigil (modafinil)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of AE's and SAE's to determine safety of combination
Secondary outcomes (1)
Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Research
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey A Wilken, Ph.D., Principal investigator, Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210301
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 7 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS
- ClinicalTrials.gov ID
- NCT00210301
- Acronym / sponsor ID
- 001
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- MS, cognition, attention, fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Institute for Clinical ResearchUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 21 Sep 2005 (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.
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.
Detailed description
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. Although certain immunomodulatory treatments may slow the progression of cogntiive difficulties, they are not therapy for the progression of or new onset of such problems. Therefore, in order to treat such problems, it is likely that adjunctive medications focused on fatigue and cognition are needed. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.
Study Period: 6 to 12-month competitive enrollment period, two groups (Avonex and Avonex +Provigil 200 mg QD ) undergo baseline (prior to starting Provigil), 2-month, and 4-month neuropsychological evaluations. Total length of study, once initiated, (including 2 month preparation period, 6 to 12-month competitive enrollment period through final four-month visit) is 12 to 18 months.
Primary Objective: To investigate whether Provigil in combination with Avonex is safe, and tolerable in patients with RRMS.
Secondary Objectives:
- To determine whether Provigil (modafinil) in combination with Avonex(interferon β-1a) is useful in treating deficits in attention, as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether combination therapy (Avonex +Provigil) favorably impacts other domains of cognition that are reliant on attention (e.g., memory, psychomotor functioning), as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients entering the study will:
Key exclusion criteria (16 listed)
- Patients entering the study will NOT:
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 |
|---|---|---|
| Provigil (modafinil) | Drug | – |
Primary outcome
Comparison of AE's and SAE's to determine safety of combination
1 secondary outcome
Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2006.
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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.
Jeffrey A Wilken, Ph.D. principal investigator
Institute for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provigil (modafinil) in people with Relapsing-Remitting Multiple Sclerosis, run by Institute for Clinical Research 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 16 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 7 Sep 2006. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey A Wilken, Ph.D. (202-745-8000 ext. 7251, jeffrey.wilken@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of AE's and SAE's to determine safety of combination. 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 7 Sep 2006.