NCT03091569 (VITALITY) is a Phase 4 clinical trial of Vitamin K Cream in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen.

Who is sponsoring NCT03091569?

NCT03091569 is sponsored by Biogen.

What drugs are being tested in NCT03091569?

Interventions in NCT03091569: Vitamin K Cream, Placebo Cream.

What condition does NCT03091569 study?

NCT03091569 studies Relapsing-Remitting Multiple Sclerosis.

Is NCT03091569 still recruiting?

NCT03091569 is currently completed. Last updated 5 April 2018.

Last reviewed 2018-04-05 · How we verify

NCT03091569: VITALITY

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

Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy

Completed Phase 4 Last updated 5 April 2018

What this trial tests

Phase 4 trial testing Vitamin K Cream in Relapsing-Remitting Multiple Sclerosis in 23 participants. Completed in 27 January 2018.

Timeline

10 March 2017

Primary endpoint
27 January 2018

27 January 2018

Quick facts

Lead sponsor	Biogen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	supportive care
Enrollment	23
Start date	10 March 2017
Primary completion	27 January 2018
Estimated completion	27 January 2018
Sites	1 location across Italy

Drugs / interventions tested

Vitamin K Cream
Placebo Cream

Conditions studied

Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →

Sponsor

Biogen — full company profile →

Who can join

18 and older, any sex, with Relapsing-Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment. The secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Relapsing-Remitting Multiple Sclerosis

Currently open trials in the same condition.

NCT05123703 — A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Re · Phase 3 · active not recruiting
NCT05090371 — A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation · Phase 4 · active not recruiting
NCT04530318 — Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis · Phase 2 · active not recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · 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 NCT03091569 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 5 April 2018

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/NCT03091569.

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