NCT03400852 (BRAVE) is a Phase 2 clinical trial of MNK-1411 in Muscular Dystrophy, Duchenne, sponsored by Mallinckrodt ARD LLC.

Who is sponsoring NCT03400852?

NCT03400852 is sponsored by Mallinckrodt ARD LLC.

What drugs are being tested in NCT03400852?

Interventions in NCT03400852: MNK-1411, Placebo.

What condition does NCT03400852 study?

NCT03400852 studies Muscular Dystrophy, Duchenne.

Is NCT03400852 still recruiting?

NCT03400852 is currently terminated. Last updated 16 March 2021.

Are results published for NCT03400852?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-16 · How we verify

NCT03400852: BRAVE

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

A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy

Terminated Phase 2 Results posted Last updated 16 March 2021

What this trial tests

Phase 2 trial testing MNK-1411 in Muscular Dystrophy, Duchenne in 44 participants. Terminated before completion.

Timeline

27 July 2018

Primary endpoint
25 February 2020

25 February 2020

Quick facts

Lead sponsor	Mallinckrodt ARD LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	27 July 2018
Primary completion	25 February 2020
Estimated completion	25 February 2020
Sites	16 locations across Italy, Serbia, Israel, Mexico, Bulgaria, United States, Turkey (Türkiye), Spain

Drugs / interventions tested

MNK-1411 — full drug profile →
Placebo

Conditions studied

Muscular Dystrophy, Duchenne — all drugs for Muscular Dystrophy, Duchenne →

Sponsor

Mallinckrodt ARD LLC — full company profile →

Who can join

Adults 4 to 8, male only, with Muscular Dystrophy, Duchenne. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Complete 10 Meter Walk/Run[ Primary · Baseline, Week 24

10 Meter Walk/Run is a motor function test to measure the functional capability in patients with DMD.

at Baseline

Group	Value	95% CI
Period 1: MNK-1411	5.9	4.7 – 22.3
Period 1: Placebo	7.8	3.9 – 13.0

at Week 24

Group	Value	95% CI
Period 1: MNK-1411	5.4	4.1 – 8.9
Period 1: Placebo	8.7	3.3 – 18.3

North Star Ambulatory Assessment (NSAA) Score Secondary · Baseline, Week 24

The NSAA is comprised of 17 items, each of which is graded using the standard scorecard. Each assessment is rated as 0 - unable to achieve independently, 1 - modified method but achieves goal independent of physical assistance from another, or 2 - normal with no obvious modification of activity. The subscale scores are summed for a total score ranging from 0 to 34. The higher the total score, the better the outcome.

at Baseline

Group	Value	95% CI
Period 1: MNK-1411	17.9	± 6.80
Period 1: Placebo	17.1	± 6.40

at Week 24

Group	Value	95% CI
Period 1: MNK-1411	20.5	± 7.94
Period 1: Placebo	16.6	± 8.82

Time to Climb 4 Standardized Stairs Secondary · Baseline, Week 24

Time to Climb 4 Standardized Stairs is a motor performance test

at Baseline

Group	Value	95% CI
Period 1: MNK-1411	8.52	± 8.88
Period 1: Placebo	8.47	± 4.34

at Week 24

Group	Value	95% CI
Period 1: MNK-1411	4.71	± 2.45
Period 1: Placebo	15.09	± 13.84

Time to Stand From a Supine Position Secondary · Baseline, Week 24

Time to stand from a supine position is a motor function test to measure the functional capability in subjects with DMD.

at Baseline

Group	Value	95% CI
Period 1: MNK-1411	11.14	± 9.08
Period 1: Placebo	15.03	± 12.45

at Week 24

Group	Value	95% CI
Period 1: MNK-1411	7.65	± 4.99
Period 1: Placebo	24.89	± 26.48

Quantitative Muscle Testing Scores at Baseline Secondary · Baseline

Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer

Knee flexion

Group	Value	95% CI
Period 1: MNK-1411	26.61	± 14.17
Period 1: Placebo	29.87	± 14.17

Knee extension

Group	Value	95% CI
Period 1: MNK-1411	28.99	± 16.24
Period 1: Placebo	26.64	± 15.27

Quantitative Muscle Testing Scores at Week 24 Secondary · Week 24

Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer

Knee flexion

Group	Value	95% CI
Period 1: MNK-1411	33.64	± 1578
Period 1: Placebo	25.27	± 13.35

Knee extension

Group	Value	95% CI
Period 1: MNK-1411	26.61	± 14.17
Period 1: Placebo	29.87	± 15.13

Summary of Adverse Events in the Blinded Treatment Period Secondary · within 28 weeks

Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs)

Exposed

Group	Value	95% CI
Period 1: MNK-1411	29
Period 1: Placebo	15

Affected by serious adverse events

Group	Value	95% CI
Period 1: MNK-1411	0
Period 1: Placebo	1

Affected by non-serious adverse events

Group	Value	95% CI
Period 1: MNK-1411	22
Period 1: Placebo	15

Died from any cause

Group	Value	95% CI
Period 1: MNK-1411	0
Period 1: Placebo	0

Summary of Adverse Events in the Open Label Period Secondary · within 28 weeks

Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs)

Exposed

Group	Value	95% CI
Period 2: MNK-1411	24

Affected by serious adverse events

Group	Value	95% CI
Period 2: MNK-1411	2

Affected by non-serious adverse events

Group	Value	95% CI
Period 2: MNK-1411	11

Died from any cause

Group	Value	95% CI
Period 2: MNK-1411	0

Adverse events — posted to ClinicalTrials.gov

Time frame: within 28 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Period 1: MNK-1411

Serious: 0/29 (0%)

Deaths: 0/29

Period 1: Placebo

Serious: 1/15 (7%)

Deaths: 0/15

Period 2: MNK-1411

Serious: 2/24 (8%)

Deaths: 0/24

Serious adverse events (3 terms)

Reaction	System	Period 1: MNK-1411	Period 1: Placebo	Period 2: MNK-1411
Muscle disorder	Musculoskeletal and connective tissue disorders	—	—	—
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	—	—	—
nary tract infection	Infections and infestations	—	—	—

Other adverse events (77 terms — click to expand)

Reaction	System	Period 1: MNK-1411	Period 1: Placebo	Period 2: MNK-1411
Weight increased	Investigations	—	—	—
Injection site erythema	General disorders	—	—	—
Injection site induration	General disorders	—	—	—
Injection site mass	General disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Pharyngotonsillitis	Infections and infestations	—	—	—
Face oedema	General disorders	—	—	—
Injection site pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Hypertrichosis	Skin and subcutaneous tissue disorders	—	—	—
Cushingoid	Endocrine disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Haematoma	Vascular disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Allergy to arthropod bite	Immune system disorders	—	—	—
Fatigue	General disorders	—	—	—
Injection site bruising	General disorders	—	—	—
Injection site haematoma	General disorders	—	—	—
Injection site haemorrhage	General disorders	—	—	—
Injection site irritation	General disorders	—	—	—
Injection site swelling	General disorders	—	—	—
Swelling face	General disorders	—	—	—
Affect lability	Psychiatric disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Mood swings	Psychiatric disorders	—	—	—
Separation anxiety disorder	Psychiatric disorders	—	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—	—
Nerve stimulation test abnormal	Investigations	—	—	—
Congestive cardiomyopathy	Cardiac disorders	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Muscle disorder, Rhabdomyolysis, nary tract infection.

Data from ClinicalTrials.gov NCT03400852 adverse events section.

Sponsor's own description

This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).

Publications & conference data

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

Standard of care versus new-wave corticosteroids in the treatment of Duchenne muscular dystrophy: Can we do better?
Kourakis S, Timpani CA, Campelj DG, Hafner P, et al · · 2021 · cited 73× · PMID 33663533 · DOI 10.1186/s13023-021-01758-9
Lessons Learned from Discontinued Clinical Developments in Duchenne Muscular Dystrophy.
Markati T, De Waele L, Schara-Schmidt U, Servais L. · · 2021 · cited 30× · PMID 34790118 · DOI 10.3389/fphar.2021.735912

Verify or expand the search:

Other recruiting trials for Muscular Dystrophy, Duchenne

Currently open trials in the same condition.

NCT06833489 — Transcriptomic Analysis to Put an End to Misdiagnosis in Patients With Rare Muscle Diseases · NA · recruiting
NCT06363357 — The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients Wi · NA · recruiting
NCT05066633 — The Efficacy and Safety of Metoprolol as add-on Treatment to Standard of Care in Preventing Cardiomyopathy in Patients W · Phase 3 · recruiting
NCT04626674 — A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in P · Phase 1 · recruiting
NCT03992430 — A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD · Phase 3 · active not recruiting

Other Mallinckrodt ARD LLC trials

Trials by the same sponsor.

NCT03126760 — Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS) · Phase 4 · terminated
NCT02633046 — Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria · Phase 4 · completed

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 NCT03400852 (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 Mallinckrodt ARD LLC
Last refreshed: 16 March 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/NCT03400852.

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

NCT03400852: BRAVE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Muscular Dystrophy, Duchenne

Other Mallinckrodt ARD LLC trials

Verify against primary sources