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GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease
NCT05686551 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease (HD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tominersen
Study Locations (20)
Florida
- University of Florida — Gainesville
- University of South Florida — Tampa
Washington
- EvergreenHealth Investigational Drug Services — Kirkland
- Inland Northwest Research — Spokane
Other
- CINME — Buenos Aires
- Hospital Ramos Mejía — CABA
Alabama
- Uab Medicine — Birmingham
Arizona
- Barrow Neurological Institute — Phoenix
California
- University of California Davis Medical System — Sacramento
Colorado
- CenExel Rocky Mountain Clinical Research, LLC — Englewood
District of Columbia
- Georgetown University — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05686551
The ClinicalTrials.gov registry entry for NCT05686551 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 301 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 Placebo 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: NCT05686551 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Florida, Washington, Other. 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 NCT05686551 about?
NCT05686551 is a clinical study titled "GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease". This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease (HD).
What is the current status of trial NCT05686551?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2023-02-03. Estimated completion is 2027-04-01.
What conditions does trial NCT05686551 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 NCT05686551?
The interventions under investigation include: Placebo (DRUG), Tominersen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05686551?
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 NCT05686551 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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