Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

NCT04002102 | Completed

• 1 other identifier: IRB-300003575
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Fatigue

Keywords

Placebo; Open-Label

Outcome Measures

Primary Outcomes (3)

• Change from baseline fatigue at 21 days using the Fatigue Severity Scale (FSS).

  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).

  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).

  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 Outcomes (3)

• Change from baseline sleepiness at 21 days using the Epworth Sleepiness Scale (ESS).

  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).

  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

  Participants will complete this scale at baseline and 21 days later

Other Outcomes (1)

• Change from baseline general self efficacy for managing chronic conditions at 21 days using the PROMIS instrument

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

Study Arms (3)

OLP treatment

EXPERIMENTAL

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

Usual care

OTHER

Participants randomized to the no treatment group will remain in standard care alone for 21 days and receive educational materials.

Other: Usual care

Expectancy Group

ACTIVE COMPARATOR

Participants receive educational materials and positive expectancy orientation via Zoom or telephone

Other: Expectancy Group

Interventions

OLP treatment OTHER

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.

Also known as: Open-Label placebo, Glucose Tablet

OLP treatment

Usual care OTHER

Remain in standard care after randomization and educational materials.

Also known as: Standard care

Usual care

Expectancy Group OTHER

Educational materials and positive expectancy orientation via Zoom or telephone

Also known as: Education

Expectancy Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

Tanner Foundation

Birmingham, Alabama, 35209, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Baidwan NK, Tracy T, Chiu CY, Nawshin T, Hoenemeyer T, Riser E, Motl R, Fontaine K, Mehta T. Open label placebo to treat fatigue in people with multiple sclerosis: feasibility and preliminary effects. Pilot Feasibility Stud. 2025 Jul 3;11(1):93. doi: 10.1186/s40814-025-01674-w.

  PMID: 40611184 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Glucose; Standard of Care; Educational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Socioeconomic Factors; Population Characteristics

Study Officials

• Tapan S Mehta, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 28, 2019
• Study Start: February 17, 2020
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be posted on CT.gov
• Access Criteria: To be determined

Locations

US (2)