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NCT04002102
Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
NA trial testing OLP treatment in Multiple Sclerosis in 48 participants. Completed in 19 January 2022.
19 January 2022
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 17 February 2020 |
| Primary completion | 19 January 2022 |
| Estimated completion | 19 January 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- OLP treatment
- Usual care
- Expectancy Group
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Fatigue — all drugs for Fatigue →
Sponsor
University of Alabama at Birmingham
Who can join
19 and older, any sex, with Multiple Sclerosis or Fatigue. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Open label placebo to treat fatigue in people with multiple sclerosis: feasibility and preliminary effects.
Baidwan NK, Tracy T, Chiu CY, Nawshin T, et al · · 2025 · PMID 40611184 · DOI 10.1186/s40814-025-01674-w
Verify or expand the search:
- PubMed search for NCT04002102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University of Alabama at Birmingham trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04002102 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 1 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04002102.
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