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Trial record 29 of 239 for:    (armodafinil)

Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue (COMBO-MS)

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ClinicalTrials.gov Identifier: NCT03621761
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
University of Washington
Patient-Centered Outcomes Research Institute
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Tiffany J. Braley, MD, MS, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Telephone-based Cognitive Behavioral Therapy Drug: Modafinil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Rater blinded
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cognitive Behavioral Therapy
8 weekly telephone-based sessions and 2 booster sessions
Behavioral: Telephone-based Cognitive Behavioral Therapy
Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. "coping skills"). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue.

Active Comparator: Modafinil
50-400 mg per day (oral)
Drug: Modafinil
Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily).
Other Name: Provigil

Active Comparator: Cognitive Behavioral Therapy + Modafinil
Telephone-based cognitive behavioral therapy (8 weekly therapy sessions and 2 booster sessions) + Modafinil 50-400 mg per day (oral)
Behavioral: Telephone-based Cognitive Behavioral Therapy
Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. "coping skills"). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue.

Drug: Modafinil
Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily).
Other Name: Provigil




Primary Outcome Measures :
  1. Change in the Modified Fatigue Impact Scale (MFIS) Score [ Time Frame: Baseline-12 weeks ]
    The Modified Fatigue Impact Scale is a self-report survey that contains 21 items. Each item is rated 0-4. Higher scores indicate a greater impact of fatigue on a person's activities. The primary outcome measure will be the mean within-subject difference between baseline and 12-week Modified Fatigue Impact Scale values (delta-MFIS), compared between the 3 treatment groups.


Secondary Outcome Measures :
  1. Change in fatigue intensity as assessed by self-reported Numerical Rating Scale (NRS) score. [ Time Frame: Baseline-12 weeks ]

    Fatigue intensity will be assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface.

    Using a 0-10 numerical rating scale, participants will rate their fatigue intensity, and enter the score into the user-interface on the PRO-Diary four times each day, for 7 days, at baseline (pre-intervention) and at 12 weeks post-intervention. All scores over the 7 days will be averaged to produce an aggregate fatigue intensity score. Higher scores indicate greater fatigue intensity. Change in fatigue intensity between baseline and 12 weeks will be compared between the 3 treatment groups.


  2. Change in fatigue impact as assessed by self-reported Numerical Rating Scale (NRS) score [ Time Frame: Baseline-12 weeks ]

    Fatigue impact will be assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface.

    Using a 0-10 numerical rating scale, participants will rate their fatigue impact, and enter the score into the user-interface on the PRO-Diary four times each day, for 7 days, at baseline (pre-intervention) and at 12 weeks post-intervention. All scores over the 7 days will be averaged to produce an aggregate fatigue impact score. Higher scores indicate greater fatigue impact. Change in fatigue impact between baseline and 12 weeks will be compared between the 3 treatment groups.


  3. Change in Physical Fatigability as assessed by the self-reported fatigue intensity Numerical Rating Scale (NRS) score and physical activity level [ Time Frame: Baseline-12 weeks ]

    Fatigability will be assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface.

    The fatigability score will be calculated as the ratio of the self-reported fatigue intensity rating (using a 0-10 numerical rating score) divided by the participant's concurrent physical activity level (measured as the average number of activity counts per minute). All fatigability scores will be averaged over the 7 days to create an aggregate fatigability score. Higher scores indicate greater fatigability. Change in fatigability between baseline and 12 weeks will be compared between the 3 treatment groups.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621761


Contacts
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Contact: Jennifer Miner 734-763-3982 jenminer@med.umich.edu
Contact: Shubha Kulkarni 734-615-3330 shubhak@med.umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Tiffany Braley, MD, MS         
Principal Investigator: Anna Kratz, PhD         
United States, Washington
The University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Sandra Reeves    855-320-8230    sandrar@uw.edu   
Sponsors and Collaborators
University of Michigan
University of Washington
Patient-Centered Outcomes Research Institute
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Tiffany J Braley, MD, MS University of Michigan

Publications:

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Responsible Party: Tiffany J. Braley, MD, MS, Assistant Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT03621761     History of Changes
Other Study ID Numbers: HUM00143319
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tiffany J. Braley, MD, MS, University of Michigan:
cognitive behavioral therapy
modafinil
Provigil
fatigue
MS

Additional relevant MeSH terms:
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Modafinil
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action