Source: Doctors Guide
Date: 1 October 2006

Combination of Modafinil and Interferon-Beta-1a Appears Effective and Safe for Treatment of Cognitive Symptoms in Multiple Sclerosis: Presented at ECTRIMS

By Bruce Sylvester

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MADRID, SPAIN -- October 1, 2006 -- Adjunctive use of modafinil with interferon-beta-1a (Avonex) for breakthrough cognitive symptoms of multiple sclerosis (MS) appears to be safe and effective, and it could offer another available treatment option, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"When MS patients who took Provigil were compared to those who did not, we saw that the Provigil patients performed better on several measures of cognition and quality-of-life," said presenter Cynthia Sullivan, PhD, neuropsychologist, Veteran's Administration Hospital, Washington, D.C, United States.

In their background material, Dr. Sullivan and colleagues noted that while there is evidence that treatment of MS with interferons can slow the progression of cognitive dysfunction associated with the disease, there is little data about treating the breakthrough cognitive symptoms -- attention, processing speed, and memory problems.

"Although studies have recently demonstrated the benefits of using modafinil as an adjunctive therapy to treat fatigue caused by MS, there are no data on whether this treatment translates into improved functioning in patients with cognitive impairment that progresses even while on a disease-modifying agent," the researcher wrote.

The purpose of this study was to see whether combination therapy of modafinil plus interferon beta-1a is safe and effective in treating the progression of cognitive deficits in MS.

The investigators enrolled 59 subjects, 29 in the combination group and 30 in the IFN-beta-1a monotherapy group. Of these, 48 subjects completed the 4-month evaluation.

Patients, who were all receiving interferon beta-1a treatment before enrolment, completed an attention screening battery. The researchers randomized those who showed significant attention problems to receive modafinil 200 mg/day or no additional treatment. Evaluators were blinded to each subject's treatment status.

Mean age at baseline was 47.11 +/- 10.03 years, mean years of education were 14.85 +/- 2.19, mean score on the Expanded Disability Status Scale was 3.95 +/- 2.06, and mean estimated Full Scale IQ was 107.72 +/- 7.49.

The investigators reported that there were no significant differences in demographic variables between groups.

At baseline and at 4 months, all subjects underwent complete neuropsychological testing, including measures of mood and quality of life (QOL). Side effects were closely monitored to study safety of the combination treatment.

When compared with the interferon-beta-1a monotherapy group, subjects receiving combination therapy showed significant improvement from baseline on neurocognitive, fatigue, mood, and QOL measures at 4 months.

"In this pilot study, the use of modafinil in addition to interferon-beta-1a (Avonex) for breakthrough cognitive symptoms appeared to be safe and effective," the authors wrote.

They also noted that adverse effects of combination therapy were mild and did not vary from those described in the package inserts for both medications.

"This gives another possible option to clinicians for treating fatigue and cognitive problems associated with MS," Dr. Sullivan said.
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