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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hoffmann-La Roche
Study ID
NCT06826612
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SPK-10001 — GENETIC
    Specified dose on specified days
  • Placebo Surgery Control — OTHER
    Placebo Surgery procedure for SPK-10001

Study Details

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

Key Dates

Start date
Feb 21, 2025
Status verified
Apr 2026
Primary completion
Jan 12, 2035
Completion
Jan 12, 2035

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SPK-10001
  • Other: Placebo Surgery Control

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to approximately 5 years ]

Central Contacts

  • Reference Study ID Number: SPK-10001-101 https://forpatients.roche.com/
    888-662-6728
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
University of Cincinnati/Cincinnati Children's HospitalCincinnatiOhio45221-
Ohio State UniversityColumbusOhio43221-
University of PennsylvaniaPhiladelphiaPennsylvania19107-
University of PittsburgPittsburghPennsylvania15213-

Find similar trials in Boston, MA

By condition
Huntington disease
By specialty
NeurologyBrain disorders
By research site
Beth Israel Deaconess Medical Center· Boston, MAUniversity of Cincinnati/Cincinnati Children's Hospital· Cincinnati, OHOhio State University· Columbus, OHUniversity of Pennsylvania· Philadelphia, PAUniversity of Pittsburg· Pittsburgh, PA

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