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NCT05686551 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Huntington Disease, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 2
Development phase
301
Enrollment target
20
Study locations

NCT05686551 is a Phase 2 study of Huntington Disease that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 301 participants, below the 627-participant average among 35 other Huntington Disease trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT05686551, a Phase 2 study of Huntington Disease, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
301 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 301 participants
Start Date 2023-02-03
Est. Completion 2027-04-01
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT05686551

The ClinicalTrials.gov registry entry for NCT05686551 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 627-participant average among 35 other Huntington Disease trials with a reported enrollment target (52% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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.

NCT05686551 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Florida, Washington, Other.

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.

What interventions are being tested in trial NCT05686551?

The interventions under investigation include: Placebo (DRUG), Tominersen (DRUG).

Who is sponsoring clinical trial NCT05686551?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.