Hackensack, NJNCT05371613Now EnrollingIRB Ready

Hunter syndrome Clinical Trial in Hackensack, NJ

Access cutting-edge hunter syndrome treatment through this clinical trial at a research site in Hackensack. Study-provided care at no cost to qualified participants.

Sponsored by Denali Therapeutics Inc.

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Expert Care in Hackensack

Access hunter syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hunter syndrome treatment provided free

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Check if you qualify for this hunter syndrome clinical trial in Hackensack, NJ

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Hackensack

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Hackensack site if eligible
  4. 4Begin participation

About This Hunter syndrome Study in Hackensack

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

Sponsor: Denali Therapeutics Inc.

Who Can Participate

Inclusion Criteria

Participants aged ≥2 to \<6 years (Cohort A) or ≥6 to \<26 years (Cohort B)
Confirmed diagnosis of MPS II (for Cohort A, nMPS II; for Cohort B, nnMPS II)
Have no history of treatment with enzyme replacement therapy (ERT) OR not have received continuous ERT for 4 months prior to screening OR be on maintenance ERT and have tolerated idursulfase for a minimum of 4 months prior to screening Key

Exclusion Criteria

Have a documented mutation of other genes or genetic diagnosis accounting for developmental delay
Previously received an iduronate 2-sulfatase (IDS) gene therapy or stem cell therapy
Received any CNS-targeted MPS ERT within 6 months prior to screening
Have a contraindication for lumbar punctures and/or magnetic resonance imaging (MRI)
Participated in any other investigational drug study or used an investigational drug within 60 days prior to screening or intend to receive another investigational drug during the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hackensack?

Yes, this clinical trial (NCT05371613) has an active research site in Hackensack, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hunter syndrome Treatment Options in Hackensack, NJ

If you're searching for hunter syndrome treatment options in Hackensack, NJ, this clinical trial (NCT05371613) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hackensack research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hunter syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hunter syndrome clinical trials near you to find additional studies recruiting in your area.

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