NCT04035889 is a NA clinical trial of Melatonin in Multiple Sclerosis, sponsored by University of California, San Francisco.

Who is sponsoring NCT04035889?

NCT04035889 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT04035889?

Interventions in NCT04035889: Melatonin, Placebo.

What condition does NCT04035889 study?

NCT04035889 studies Multiple Sclerosis.

Is NCT04035889 still recruiting?

NCT04035889 is currently completed. Last updated 19 January 2021.

Last reviewed 2021-01-19 · How we verify

NCT04035889

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Melatonin for Sleep in MS

Completed NA Last updated 19 January 2021

What this trial tests

NA trial testing Melatonin in Multiple Sclerosis in 30 participants. Completed in 17 November 2020.

Timeline

23 September 2019

Primary endpoint
17 November 2020

17 November 2020

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	23 September 2019
Primary completion	17 November 2020
Estimated completion	17 November 2020
Sites	1 location across United States

Drugs / interventions tested

Melatonin (MELATONIN) — full drug profile →
Placebo

Conditions studied

Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of California, San Francisco

Who can join

Adults 20 to 70, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration. To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of melatonin on sleep disturbances in multiple sclerosis: A randomized, controlled pilot study.
Hsu WY, Anderson A, Rowles W, Peters KE, et al · · 2021 · cited 6× · PMID 34777854 · DOI 10.1177/20552173211048756

Verify or expand the search:

Other trials of Melatonin

Trials testing the same drug.

NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other University of California, San Francisco trials

Trials by the same sponsor.

NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04035889 (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 California, San Francisco
Last refreshed: 19 January 2021

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/NCT04035889.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing