Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210301
Status:
UNKNOWN
Last Update Posted:
2006-09-07
First Post:
2005-09-13
Brief Title:
Combination Therapy Provigil Avonex to Treat Cognitive Problems in MS
Sponsor:
Institute for Clinical Research
Organization:
Institute for Clinical Research
Study Overview
Official Title:
Combination Therapy Provigil Avonex in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS
Status:
UNKNOWN
Status Verified Date:
2005-08
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:
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
1 To determine whether Provigil modafinil in combination with Avonexinterferon β-1a is useful in treating deficits in attention as measured by objective neuropsychological tests in patients with RR-MS
2 To determine whether combination therapy Avonex Provigil favorably impacts other domains of cognition that are reliant on attention eg memory psychomotor functioning as measured by objective neuropsychological tests in patients with RR-MS
3 To determine whether improvement in fatigue related to treatment predicts improvements in attention and cognitive performance in MS patients
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
1 To determine whether Provigil modafinil in combination with Avonexinterferon β-1a is useful in treating deficits in attention as measured by objective neuropsychological tests in patients with RR-MS
2 To determine whether combination therapy Avonex Provigil favorably impacts other domains of cognition that are reliant on attention eg memory psychomotor functioning as measured by objective neuropsychological tests in patients with RR-MS
3 To determine whether improvement in fatigue related to treatment predicts improvements in attention and cognitive performance in MS patients
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