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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03621761
• Date of registration: 03/08/2018
• Prospective Registration: Yes
• Primary sponsor: University of Michigan
• Public title: Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue COMBO-MS
• Scientific title: A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis
• Date of first enrolment: November 15, 2018
• Target sample size: 343
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03621761
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Tiffany J Braley, MD, MS
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with clinically definite Multiple Sclerosis (MS, all MS subtypes);

2. Age 18 years or older;

3. Presence of chronic, problematic fatigue that, in the opinion of the patient, has
interfered with their daily activities for = 3 months;

4. Average Fatigue Severity Scale (FSS) score greater or equal to 4 at screening.

Exclusion Criteria:

1. Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and
multiple sleep latency test

2. History of MS relapse within the last 30 days prior to screening (participants will be
considered eligible after the 30-day window);

3. Current stimulant or wake-promoting agent use (such as amantadine, modafinil,
methylphenidate, or amphetamine) within 30 days of screening;

4. Pregnancy or breastfeeding;

5. 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;

6. Current suicidal ideation (SI) with intent or plan;

7. Known hypersensitivity to modafinil or armodafinil or its inactive ingredients;

8. 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;

9. History of prescription or illicit stimulant abuse (such as cocaine, amphetamine,
methamphetamine);

10. Any other medical, neurological, or psychiatric condition that, in the opinion of the
investigators, could affect participant safety or eligibility.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Behavioral: Telephone-based Cognitive Behavioral Therapy

Drug: Modafinil

Primary Outcome(s)

Change in the Modified Fatigue Impact Scale (MFIS) Score [Time Frame: Baseline-12 weeks]

Secondary Outcome(s)

Change in Fatigability as Assessed by the Self-reported Fatigue Intensity Numerical Rating Scale (NRS) Score and Physical Activity Level [Time Frame: Baseline-12 weeks]

Change in Fatigue Interference as Assessed by Self-reported Numerical Rating Scale (NRS) Score [Time Frame: Baseline-12 weeks]

Change in Fatigue Intensity as Assessed by Self-reported Numerical Rating Scale (NRS) Score. [Time Frame: Baseline-12 weeks]

Secondary ID(s)

HUM00143319

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Patient-Centered Outcomes Research Institute

National Multiple Sclerosis Society

University of Washington

Results

• Results available: Yes
• Date Posted: 27/12/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03621761