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Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002102
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tapan Shirish Mehta, University of Alabama at Birmingham

Brief Summary:

Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence. Recent studies show that non-deceptive open-label placebos (OLP) have moderate-to-large effects on symptoms, including fatigue, in adults with a variety of medical conditions.

Hence, this is a pilot and feasibility study to obtain data on the feasibility and effects of OLP for multiple sclerosis related fatigue and its impact to provide the basis for a competitive NIH application. This pilot study will be the first study to evaluate whether OLP, that garners full consent and engages patients in their wellness, may offer a safe, effective treatment for multiple sclerosis related fatigue.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Fatigue Other: OLP treatment Other: Usual care Other: Expectancy Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OLP treatment
Participants randomized to the treatment group will receive: 1) educational materials; 2) positive expectancy; 3) 2 placebo pills twice a day for 21 days.
Other: OLP treatment
Receive two open-label placebo pills twice a day after randomization. Will receive for 21 days and then stop. It will include educational materials and positive expectancy.
Other Names:
  • Open-Label placebo
  • Glucose Tablet

Usual care
Participants randomized to the no treatment group will remain in standard care alone for 21 days and receive educational materials.
Other: Usual care
Remain in standard care after randomization and educational materials.
Other Name: Standard care

Active Comparator: Expectancy Group
Participants receive educational materials and positive expectancy orientation via Zoom or telephone
Other: Expectancy Group
Educational materials and positive expectancy orientation via Zoom or telephone
Other Name: Education




Primary Outcome Measures :
  1. Change from baseline fatigue at 21 days using the Fatigue Severity Scale (FSS). [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 10 minutes each assessment completing this scale. ]
    This scale is used to measure fatigue and the scale has a range from 9-63 with 9 being the best possible score and 63 being the worst score.

  2. Change from baseline impact of fatigue at 21 days using the Modified Fatigue Impact Scale (MFIS). [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale. ]
    This scale is used to measure fatigue and the scale has a range from 0 to 84 with 0 being the best possible score and 84 being the worst score.

  3. Change from baseline quality of life at 21 days using the 36-item Short Form survey (SF-36). [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale. ]
    The scores for this survey range from 0-100 with 0 being the worst possible score and 100 being the best possible score.


Secondary Outcome Measures :
  1. Change from baseline sleepiness at 21 days using the Epworth Sleepiness Scale (ESS). [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale. ]
    This scale is used to measure sleepiness and the scale has a range from 0-24 with 0 being the best possible score and 24 being the worst.

  2. Change from baseline neurological functioning at 21 days using the Perceived Deficit Questionnaire 5-Item Version (PDQ-5). [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale. ]
    The scores for this questionnaire range from 5-25 with 5 being the best possible score and 25 being the worst possible score.

  3. Godin Leisure-Time Exercise Questionnaire [ Time Frame: Participants will complete this scale at baseline and 21 days later ]
    A self-explanatory, brief four-item query of usual leisure-time exercise habits


Other Outcome Measures:
  1. Change from baseline general self efficacy for managing chronic conditions at 21 days using the PROMIS instrument [ Time Frame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale. ]
    The scores for this tool are coded separately for each of the 10 questions and range from 1-5 for questions Global01-06, 08r, 09r, and 10r with 1 being the worst possible score and 5 being the best possible score and a range from 0-10 for question Global07r with 0 being the worst possible score and 10 being the best possible score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of MS
  • Aged 19 years or older
  • report moderate-to-severe fatigue (i.e., ≥4 on the FSS)
  • an Expanded Disability Status Scale (EDSS) score of <7,

Exclusion Criteria:

  • Major comorbid conditions that might influence fatigue (e.g. lupus, chronic fatigue syndrome)
  • Patients treated with off label medications or exercise program in the past 30 days.

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): NCT04002102


Contacts
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Contact: Aizhan Karabukayeva, MPH 205-5155146 Ak1984@uab.edu

Locations
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United States, Alabama
Tanner Foundation Recruiting
Birmingham, Alabama, United States, 35209
Contact: Tracy Tracy, OT         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Aizhan Karabukayeva, MPH    205-515-5146    Ak1984@uab.edu   
Principal Investigator: Tapan S Mehta         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Tapan S Mehta, PhD University of Alabama at Birmingham
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Responsible Party: Tapan Shirish Mehta, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04002102    
Other Study ID Numbers: IRB-300003575
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be determined. Sharing study protocol, statistical analysis plan, and informed consent.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Will be posted on CT.gov
Access Criteria: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tapan Shirish Mehta, University of Alabama at Birmingham:
Placebo
Open-Label
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases