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RECRUITING Phase 1

A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease

NCT06826612 · View on ClinicalTrials.gov ↗

Study Summary

The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.

Conditions Studied

Interventions

  • GENETIC SPK-10001
  • OTHER Placebo Surgery Control

Study Locations (5)

Ohio

  • University of Cincinnati/Cincinnati Children's Hospital — Cincinnati
  • Ohio State University — Columbus

Pennsylvania

  • University of Pennsylvania — Philadelphia
  • University of Pittsburg — Pittsburgh

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2025-02-21
Est. Completion 2035-01-12
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06826612

The ClinicalTrials.gov registry entry for NCT06826612 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Huntington Disease appearing as the primary indexed condition, and to 2 interventions — of which SPK-10001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06826612 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Ohio, Pennsylvania, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06826612 about?

NCT06826612 is a clinical study titled "A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease". The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.

What is the current status of trial NCT06826612?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2025-02-21. Estimated completion is 2035-01-12.

What conditions does trial NCT06826612 study?

This clinical trial studies the following conditions: Huntington Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06826612?

The interventions under investigation include: SPK-10001 (GENETIC), Placebo Surgery Control (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06826612?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06826612 being conducted?

This trial has 5 study locations across Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial