NCT01128855 (DEMAND I) is a Phase 1 clinical trial of 3 mg/kg GSK2402968 in Muscular Dystrophies, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01128855?

NCT01128855 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01128855?

Interventions in NCT01128855: 3 mg/kg GSK2402968, 6 mg/kg GSK2402968, 9 mg/kg GSK2402968, 12 mg/kg GSK2402968, Placebo.

What condition does NCT01128855 study?

NCT01128855 studies Muscular Dystrophies.

Is NCT01128855 still recruiting?

NCT01128855 is currently completed. Last updated 18 July 2017.

Last reviewed 2017-07-18 · How we verify

NCT01128855: DEMAND I

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

A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD Subjects

Completed Phase 1 Last updated 18 July 2017

What this trial tests

Phase 1 trial testing 3 mg/kg GSK2402968 in Muscular Dystrophies in 20 participants. Completed in 25 October 2011.

Timeline

12 July 2010

Primary endpoint
25 October 2011

25 October 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	12 July 2010
Primary completion	25 October 2011
Estimated completion	25 October 2011
Sites	2 locations across France, United States

Drugs / interventions tested

3 mg/kg GSK2402968 — full drug profile →
6 mg/kg GSK2402968 — full drug profile →
9 mg/kg GSK2402968 — full drug profile →
12 mg/kg GSK2402968 — full drug profile →
Placebo

Conditions studied

Muscular Dystrophies — all drugs for Muscular Dystrophies →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

9 and older, male only, with Muscular Dystrophies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy

Publications & conference data

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

Splice-switching antisense oligonucleotides as therapeutic drugs.
Havens MA, Hastings ML. · · 2016 · cited 402× · PMID 27288447 · DOI 10.1093/nar/gkw533
Splicing therapy for neuromuscular disease.
Douglas AG, Wood MJ. · · 2013 · cited 66× · PMID 23631896 · DOI 10.1016/j.mcn.2013.04.005
Pharmacokinetics and safety of single doses of drisapersen in non-ambulant subjects with Duchenne muscular dystrophy: results of a double-blind randomized clinical trial.
Flanigan KM, Voit T, Rosales XQ, Servais L, et al · · 2014 · cited 56× · PMID 24321374 · DOI 10.1016/j.nmd.2013.09.004
Recent developments in the treatment of Duchenne muscular dystrophy and spinal muscular atrophy.
Liew WK, Kang PB. · · 2013 · cited 20× · PMID 23634188 · DOI 10.1177/1756285612472386
Novel compounds for the treatment of Duchenne muscular dystrophy: emerging therapeutic agents.
Wilton SD, Fletcher S. · · 2011 · cited 1× · PMID 23776365 · DOI 10.2147/tacg.s8762

Verify or expand the search:

Other recruiting trials for Muscular Dystrophies

Currently open trials in the same condition.

NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
NCT07129954 — Fear of Falling in Muscular Dystrophy · NA · recruiting
NCT06378203 — Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI] · NA · recruiting
NCT06094205 — Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02) · NA · recruiting
NCT06924125 — Spanish Natural History Study for LAMA2 Muscular Dystrophy · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · 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 NCT01128855 (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 GlaxoSmithKline
Last refreshed: 18 July 2017

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/NCT01128855.

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