Rare Disease Trial, Recruiting NCT06615206 Sponsor: HuidaGene Therapeutics Co., Ltd. Condition: Rare Disease
Back to Rare Disease

Rare Disease Trial, Recruiting

NCT06615206
Recruiting Not Applicable

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 male and between 2 and 18 years old at the time of signing the consent form
  • You have been diagnosed with MECP2 Duplication Syndrome (MDS), confirmed by genetic testing and clinical assessment
  • Your seizures have been stable, or you have had no seizures, while on your current treatments (including any anti-seizure medicines and physical therapy) for at least 2 months before the study screening
  • You and your family are willing to follow the study plan, including providing biological samples and staying in hospital for a procedure to deliver treatment directly into the brain (confirm with trial site)
  • Your blood, chemistry, and urine test results are within acceptable ranges

Who may not be able to join:

  • You have a triplication (three copies) of the MECP2 gene, rather than a duplication
  • You have another genetic condition in addition to MDS
  • A brain MRI scan shows significant shrinkage of the brain or cerebellum, or other notable changes to brain structure
  • You have, or have had, high blood pressure, heart muscle disease, reduced blood flow to the heart, irregular heart rhythm, or any other significant heart or cardiovascular condition
  • You have had brain or nervous system surgery within the 6 months before joining the study
  • You have taken medicines that suppress the immune system within the 3 months before joining the study
  • You have previously received gene therapy or a type of treatment called oligonucleotide therapy
  • There is any other reason the study doctor believes you would not be able to complete the study safely or successfully (confirm with 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 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 732-318-9873

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
Not Applicable
Sponsor
HuidaGene Therapeutics Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 October 2024
Est. completion
31 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence and severity of systemic adverse events

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: 27 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