Clinical trial NCT04002102: Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
Official title: Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Keywords: Placebo
Open-Label
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline fatigue at 21 days using the Fatigue Severity Scale (FSS).
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 10 minutes each assessment completing this scale.
measure: Change from baseline impact of fatigue at 21 days using the Modified Fatigue Impact Scale (MFIS).
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
measure: Change from baseline quality of life at 21 days using the 36-item Short Form survey (SF-36).
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
Secondary outcomes:
measure: Change from baseline sleepiness at 21 days using the Epworth Sleepiness Scale (ESS).
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
measure: Change from baseline neurological functioning at 21 days using the Perceived Deficit Questionnaire 5-Item Version (PDQ-5).
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: Participants will complete this scale at baseline and 21 days later
Other outcomes:
measure: Change from baseline general self efficacy for managing chronic conditions at 21 days using the PROMIS instrument
timeFrame: Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
Locations:
city: Birmingham
country: United States
facility: Tanner Foundation
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tapan S Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References: