Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks. Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater reductions in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.

Key facts

Study ID

NCT03621761

Run by

University of Michigan

People needed

343

Starts

2018-11-15

Expected to finish

2021-11-30

Last updated by the study team

2022-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with clinically definite Multiple Sclerosis (MS, all MS subtypes);
• Age 18 years or older;
• Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months;
• Average Fatigue Severity Scale (FSS) score greater or equal to 4 at screening.

You may not qualify if…

• Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test
• History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window);
• Current stimulant or wake-promoting agent use (such as amantadine, modafinil, methylphenidate, or amphetamine) within 30 days of screening;
• Pregnancy or breastfeeding;
• Reliance on hormonal contraception AND concomitant unwillingness to use alternative non-hormonal means of birth control (spermicide or condoms) during the course of the study;
• Current suicidal ideation (SI) with intent or plan;
• Known hypersensitivity to modafinil or armodafinil or its inactive ingredients;
• History of the following cardiovascular conditions: recent myocardial infarction (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapse, NYHA class III or IV congestive heart failure;
• History of prescription or illicit stimulant abuse (such as cocaine, amphetamine, methamphetamine);
• Any other medical, neurological, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States
• The University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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