All Multiple Sclerosis PatientsNCT00220506
Fatigue Treatment Using Provigil
A study testing Provigil in people with All Multiple Sclerosis Patients, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- All Multiple Sclerosis Patients
- What is being tested?
- Provigil
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Dec 2006
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients should be diagnosed with clinically definite MS (Posner criteria).
- EDSS at screening: 0 to 5.5, inclusive.
- Positive Fatigue impact scale 40 points or more.
- Age 18-55 years.
- Co-operating patient, capable of complying with all of trial procedures (i.e. FIS, QOL, etc…).
- Patient who signed written informed consent.
- Women of childbearing potential must use effective birth control method during study.
Who cannot join
- Life threatening and/or unstable clinical condition which in the opinion of the investigator might compromise trial completion
- A relapse during the last 30 days prior to the study.
- Systemic steroid therapy within 30 days
- Known hypersensitivity or intolerance, to Provigil or related substances or to any component of the formulation.
- Sleep apnea
- Narcolepsy
- Participation in experimental drug trials during the last 30 days prior to the trial.
Trial locations and contacts
1 site in 1 country.
Mark Dolev, MD contact
Anat Achiron contact
Israel1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Center
Tel HaShomer
Mark Dolev, MD, 973-3-5303899
Mark Dolev, MD
About this study
Official title: Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
Read the detailed description
Multiple sclerosis and fatigue Fatigue is one of the most common symptoms of multiple sclerosis (MS), occurring in 30%-80% of patients and for many of them fatigue is the most disabling symptom (1).
Definition of fatigue according to the MS Council for Clinical Practice Guidelines is as follows: "A subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual and desired activities".
As fatigue is a subjective and non-specific symptom, and can easily be confused with either weakness or depressed mood, both common in MS, the following characteristics have been defined to better diagnose MS-associated fatigue:
- MS-related fatigue generally occurs on a daily basis.
- It tends to worsen as the day progresses.
- It tends to be aggravated by heat and humidity.
- It is not directly correlated with either depression or the degree of physical impairment.
- It may occur first thing in the morning even if the patient has had a restful full night's sleep.
The current medications used for the treatment of MS-associated fatigue such as amantadine hydrochloride and pemoline are useful to some, but not all patients. In a multicenter trial (2) it was found that 100 mg amantadine twice daily significantly improves fatigue. Pemoline in a placebo-controlled trial (3) failed to show significant effect on fatigue in MS patients and was poorly tolerated as side effects occurred in 25% of patients. A third trial (4) compared pemoline to amantadine and placebo, and showed only a positive trend for pemoline, while amantadine had a benefit over placebo in some fatigue measures. There was also a marked placebo effect in this trial, with approximately half of patients reporting improvement in fatigue no matter what treatment (pemoline, amantadine or placebo) they were taking.
In the current study proposal we intend to evaluate the effect of Provigil on MS-associated fatigue.
The possibility for add-on drug that will affect fatigue in MS is of importance, as fatigue has a significant impact on activities of daily living, interfering with work, family life and social activities.
1.2. The fatigue scale named "Fatigue Impact Scale" The awareness of the impact of fatigue on patient's quality of life (QOL) and the need to evaluate the effect of the different therapies on this parameter resulted in the development and validation of different questionnaires for the measurement of fatigue, i.e., the Fatigue Impact Scale (FIS), which has been shown to measure both, fatigue and treatment effect on fatigue (6-9).
The FIS is a reliable and validated 40-items questionnaire that is capable of selecting a treatment effect. It is a made up of 3 sub-scales: physical, cognitive and social. Each question is scored from 0-4, allowing a total score of 160. High scores indicate high impairment.
- Conditions
- All Multiple Sclerosis Patients
- Being tested
- Provigil
- Keywords
- provigil, fatigue, Multiple Sclerosis, cognition
- Medical subject headings
- Fatigue, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvigilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine fatigue impact scale
Secondary outcomes (1)
to determine cognition measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Multiple Sclerosis PatientsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Mark Dolev, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220506
- Sponsor's protocol ID
- SHEBA-05-3769-MD-CTIL
- Status last verified
- Feb 2006
- First submitted
- 14 Sep 2005
- Last updated
- 17 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00220506
- Acronym / sponsor ID
- SHEBA-05-3769-MD-CTIL
- Conditions
- All Multiple Sclerosis Patients
- Keywords
- provigil, fatigue, Multiple Sclerosis, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2005
- Study completion
- Dec 2006
- First posted
- 22 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.
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
Detailed description
Multiple sclerosis and fatigue Fatigue is one of the most common symptoms of multiple sclerosis (MS), occurring in 30%-80% of patients and for many of them fatigue is the most disabling symptom (1).
Definition of fatigue according to the MS Council for Clinical Practice Guidelines is as follows: "A subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual and desired activities".
As fatigue is a subjective and non-specific symptom, and can easily be confused with either weakness or depressed mood, both common in MS, the following characteristics have been defined to better diagnose MS-associated fatigue:
- MS-related fatigue generally occurs on a daily basis.
- It tends to worsen as the day progresses.
- It tends to be aggravated by heat and humidity.
- It is not directly correlated with either depression or the degree of physical impairment.
- It may occur first thing in the morning even if the patient has had a restful full night's sleep.
The current medications used for the treatment of MS-associated fatigue such as amantadine hydrochloride and pemoline are useful to some, but not all patients. In a multicenter trial (2) it was found that 100 mg amantadine twice daily significantly improves fatigue. Pemoline in a placebo-controlled trial (3) failed to show significant effect on fatigue in MS patients and was poorly tolerated as side effects occurred in 25% of patients. A third trial (4) compared pemoline to amantadine and placebo, and showed only a positive trend for pemoline, while amantadine had a benefit over placebo in some fatigue measures. There was also a marked placebo effect in this trial, with approximately half of patients reporting improvement in fatigue no matter what treatment (pemoline, amantadine or placebo) they were taking.
In the current study proposal we intend to evaluate the effect of Provigil on MS-associated fatigue.
The possibility for add-on drug that will affect fatigue in MS is of importance, as fatigue has a significant impact on activities of daily living, interfering with work, family life and social activities.
1.2. The fatigue scale named "Fatigue Impact Scale" The awareness of the impact of fatigue on patient's quality of life (QOL) and the need to evaluate the effect of the different therapies on this parameter resulted in the development and validation of different questionnaires for the measurement of fatigue, i.e., the Fatigue Impact Scale (FIS), which has been shown to measure both, fatigue and treatment effect on fatigue (6-9).
The FIS is a reliable and validated 40-items questionnaire that is capable of selecting a treatment effect. It is a made up of 3 sub-scales: physical, cognitive and social. Each question is scored from 0-4, allowing a total score of 160. High scores indicate high impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patients should be diagnosed with clinically definite MS (Posner criteria).
- EDSS at screening: 0 to 5.5, inclusive.
- Positive Fatigue impact scale 40 points or more.
- Age 18-55 years.
- Co-operating patient, capable of complying with all of trial procedures (i.e. FIS, QOL, etc…).
Key exclusion criteria (7 listed)
- Life threatening and/or unstable clinical condition which in the opinion of the investigator might compromise trial completion
- A relapse during the last 30 days prior to the study.
- Systemic steroid therapy within 30 days
- Known hypersensitivity or intolerance, to Provigil or related substances or to any component of the formulation.
- Sleep apnea
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 | Drug | – |
Primary outcome
To determine fatigue impact scale
1 secondary outcome
to determine cognition measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
Mark Dolev, MD contact
Anat Achiron contact
Mark Dolev, MD principal investigator
Sheba Medical Center
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 in people with All Multiple Sclerosis Patients, run by Sheba Medical Center at 1 site in Israel.
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 7 inclusion and 7 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 17 Feb 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 Israel. 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 Mark Dolev, MD (972-3-5303899), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine fatigue impact scale. 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 17 Feb 2006.