Who is sponsoring NCT03717961?

NCT03717961 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT03717961?

Interventions in NCT03717961: BOTOX® solution, Placebo group.

What condition does NCT03717961 study?

NCT03717961 studies Raynaud Phenomenon Secondary to Systemic Sclerosis.

Is NCT03717961 still recruiting?

NCT03717961 is currently completed. Last updated 10 February 2022.

Last reviewed 2022-02-10 · How we verify

NCT03717961: BRASS

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

Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Completed Phase 3 Last updated 10 February 2022

What this trial tests

Phase 3 trial testing BOTOX® solution in Raynaud Phenomenon Secondary to Systemic Sclerosis in 91 participants. Completed in 31 July 2020.

Timeline

15 October 2018

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	91
Start date	15 October 2018
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	1 location across France

Drugs / interventions tested

BOTOX® solution
Placebo group

Conditions studied

Raynaud Phenomenon Secondary to Systemic Sclerosis — all drugs for Raynaud Phenomenon Secondary to Systemic Sclerosis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Raynaud Phenomenon Secondary to Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to assess whether or not a single injection schedule of botulinum toxin A (BTX-A) in both hands improves Raynaud phenomenon (RP) secondary to systemic sclerosis (SSc) better than a placebo at 4, 12 and 24 weeks after the treatment. This study's hypothesis is that the number of RP attacks per week from baseline to 4 weeks after treatment is significantly lower in the group treated with BTX-A than in the control group treated by the placebo. Furthermore, BTX-A in both hands is expected to improve both symptomatic (attack frequency, digital ulcer healing) and functional (pain, hand function, quality of life) symptoms of RP secondary to SSc more than placebo.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

An update on the pharmacotherapeutic options and treatment strategies for systemic sclerosis.
McMahan ZH, Volkmann ER. · · 2020 · cited 14× · PMID 32674612 · DOI 10.1080/14656566.2020.1793960
Locoregional Treatments for Digital Ulcers in Systemic Sclerosis: A Systematic Review.
Costedoat I, Masson M, Barnetche T, Duffau P, et al · · 2021 · cited 5× · PMID 34043013 · DOI 10.2340/00015555-3839

Verify or expand the search:

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · 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 NCT03717961 (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 Assistance Publique - Hôpitaux de Paris
Last refreshed: 10 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/NCT03717961.

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