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Inland Northwest Research | Spokane, WA

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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.

Roche logo

Roche

Status and phase

Enrolling
Phase 2

Conditions

Huntington Disease

Treatments

Drug: Tominersen 60 mg
Drug: Placebo
Drug: Tominersen 100 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05686551
BN42489
Other (Other Grant/Funding Number)

Details and patient eligibility

About

This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.

Enrollment

300 estimated patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

-Huntington's disease (HD) gene expansion mutation carrier status with a CAP score of 400-500 inclusive

Either:

  • Prodromal HD (defined as DCL 2 to 3, Independence Scale (IS) ⩾70, and ⩾TFC8); or
  • Early manifest HD (defined as DCL 4, Independence Scale (IS) ⩾70, and ⩾TFC8);
  • Total body weight > 40 kg and a body mass index within the range of 18-32 kg/m2
  • Study Companion

Key Exclusion Criteria

  • Current or previous use of an ASO (including small interfering RNA) or any HTT lowering therapy (including tominersen)
  • Anti-platelet or anticoagulant therapy within 14 days prior to screening or anticipated use during the study, including, but not limited to, aspirin (unless </= 81 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, apixaban, and heparin
  • History of gene therapy, cell transplantation, or brain surgery
  • Hydrocephalus
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of study drug
  • History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 3 patient groups, including a placebo group

Tominersen 60 mg
Experimental group
Treatment:
Drug: Tominersen 60 mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Tominersen 100 mg
Experimental group
Treatment:
Drug: Tominersen 100 mg

Trial contacts and locations

73

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Central trial contact

Reference Study ID Number: BN42489 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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