Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

January 31, 2022 updated by: Tapan Shirish Mehta, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pilot study is to evaluate the feasibility of recruiting, enrolling and retaining participants in a study on the acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating MS related fatigue. Specific Aim 1 will assess the feasibility endpoints including accrual (enroll 44 participants), retention (80% of the sample) and placebo adherence (90%). Specific Aim 2 will evaluate the between-group changes in fatigue, quality of life, cognitive functioning and self-efficacy. Specific Aim 3 will evaluate participant acceptability, satisfaction and experience.

Design:

This pilot study is a randomized control trial consisting of three arms: open label placebo arm, expectancy arm, and usual care arm. The clinical coordinator will review medical records, enroll and consent participants based on the following inclusion criteria: diagnosis of MS, 19 years or older, report of moderate to severe fatigue, PDDS score of < 7, and stable dose of DMTs for 90 days.

Exclusion criteria consists of: major comorbid conditions and use of off label medications or exercise programs in the past 30 days, and if one is confined to a wheelchair.

Baseline and 21 day tele assessments will involve objective measures performed by a physical therapist, Single Digit Modality Test (SDMT) and Five Time Sit to Stand (FTSST) and subjective questionnaires sent to participant's email including Modified Fatigue Impact Scale (MFIS), Functional Systems Score (FSS), Patient Reported Outcomes Measurement Information System (PROMIS), Perceived Deficits Questionnaire, Epworth Sleepiness Scale, and the SF-36 assess of quality of life. Participants will be randomized by the clinical coordinator after baseline testing. The open label placebo and expectancy arm will meet with the care provider who will follow a scripted orientation that mimics a typical patient-provider interaction when prescribing a medication, including the rationale for effectiveness. The provider will emphasize the importance of adherence to the medication for the open label placebo arm and the breathing exercises for the expectancy arm for the next 21 days. A tracking sheet will be provided to both arms to document adherence. The usual care arm will meet with the care provider who will follow a scripted orientation on fatigue and heat management strategies. All participants will receive educational materials on fatigue and heat management. A day 11 check in call will be made to gauge progress and answer questions. After the 21 day tele assessment is performed, the participant will complete subjective questionnaires via email for 28 day and 35 day follow up.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35209
        • Tanner Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of MS
  • Aged 19 years or older
  • report moderate-to-severe fatigue (i.e., ≥4 on the FSS)
  • Patient Determined Disease Steps 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
OTHER: 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 Names:
  • 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 Names:
  • Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 10 minutes each assessment completing this scale.
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
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
Participants will complete this scale at baseline and 21 days later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Tapan S Mehta, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 17, 2020

Primary Completion (ACTUAL)

January 19, 2022

Study Completion (ACTUAL)

January 19, 2022

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300003575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be determined. Sharing study protocol, statistical analysis plan, and informed consent.

IPD Sharing Time Frame

Will be posted on CT.gov

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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