Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220506
Status:
UNKNOWN
Last Update Posted:
2006-02-17
First Post:
2005-09-14
Brief Title:
Fatigue Treatment Using Provigil
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether therapy with ModafinalProvigil 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 andor 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 nights 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
12 The fatigue scale named Fatigue Impact Scale The awareness of the impact of fatigue on patients 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 ie 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
Definition of fatigue according to the MS Council for Clinical Practice Guidelines is as follows A subjective lack of physical andor 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 nights 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
12 The fatigue scale named Fatigue Impact Scale The awareness of the impact of fatigue on patients 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None