Phase 2 Muscular Dystrophy Trial, Recruiting NCT05996003 Sponsor: NS Pharma, Inc. Condition: Muscular Dystrophy
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Phase 2 Muscular Dystrophy Trial, Recruiting

NCT05996003
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a boy aged 4 years old or older, but younger than 15 years old
  • You have a confirmed genetic change in the dystrophin gene that could be helped by a technique called "exon 44 skipping" (confirm with trial site if unsure)
  • You are able to walk on your own without any walking aids or devices
  • You are able to complete a specific "stand up from the floor" test in under 20 seconds without help
  • You have been on a stable dose of steroid medication (such as prednisone) for at least 3 months, and this dose is expected to stay the same throughout the study
  • There may be other requirements — confirm all details with the trial site

Who may not be able to join:

  • You weigh less than 20 kg (about 44 lbs) at the time of signing up (this applies to a specific part of the trial only — confirm with trial site)
  • You have a heart muscle condition that is causing symptoms
  • You have used certain muscle-building steroids (such as oxandrolone) or supplements containing resveratrol or ATP in the past 3 months
  • You have taken part in another clinical drug trial or used an experimental medicine in the past 3 months (or longer, depending on the medicine)
  • You have had surgery in the past 3 months, or surgery is planned at any point during the study
  • You have previously taken part in a specific study called NS-089/NCNP-02
  • You have received a type of treatment called "exon skipping" therapy within the past year
  • There may be other reasons that could prevent joining — confirm all details with the trial site

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-866-677-6276

Australian sites

Perth Children's Hospital, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
NS Pharma, Inc.
Registry
ClinicalTrials.gov
Start date
22 February 2024
Est. completion
11 September 2026

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇯🇵 Japan 🇳🇿 New Zealand 🇰🇷 South Korea Turkey (Türkiye) 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Adverse Event and Adverse Drug Reaction; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Plasma pharmacokinetic (PK) parameters; Urine pharmacokinetic parameters; Change from baseline in skeletal muscle dystrophin protein by immunoblot (Western blot).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov