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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

February 3, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

April 1, 2027

Conditions
Huntington Disease
Interventions
DRUG

Tominersen 60 mg

60 mg tominersen administered intrathecally every 16 weeks (Q16W).

DRUG

Placebo

Matching placebo administered intrathecally Q16W.

DRUG

Tominersen 100 mg

100 mg tominersen administered intrathecally Q16W.

Trial Locations (70)

2100

Rigshospitalet, Hukommelsesklinikken, København Ø

3050

Royal Melbourne Hospital, Parkville

3073

Neurozentrum Siloah, Gümligen

3168

Monash Medical Centre, Clayton

3240

Waikato Hospital, Hamilton

4031

Universitätsspital Basel, Basel

6009

Perron Institute for Neurological and Translational Science, Nedlands

6020

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck, Innsbruck

8011

New Zealand Brain Research Institute, Christchurch

10117

Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie, Berlin

13005

CHU de la Timone - Hopital d Adultes, Marseille

14226

Dent Neurological Institute, Amherst

15213

University of Pittsburgh, Pittsburgh

20007

Georgetown University, Washington D.C.

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

21287

John Hopkins University School of Medicine, Baltimore

23538

Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Lübeck

28034

Hospital Ramon y Cajal, Madrid

31059

CHU toulouse - Hôpital Purpan, Toulouse

32608

University of Florida, Gainesville

33076

Groupe Hospitalier Pellegrin, Bordeaux

33612

University of South Florida, Tampa

34295

Hopital Gui de Chauliac, Montpellier

35294

Uab Medicine, Birmingham

37212

Vanderbilt University Medical Center, Nashville

40139

Ospedale Bellaria, Bologna

41009

Hospital Universitario Virgen Macarena, Seville

44791

St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni, Bochum

46026

Hospital Universitario la Fe, Valencia

48202

Henry Ford Hospital, Detroit

48903

Hospital de Cruces, Barakaldo

49933

CHU Angers, Batiement Larrey 2, Neurologie, Angers

52074

Uniklinik RWTH Aachen, Aachen

52242

University of Iowa Hospitals and Clinics, Iowa City

53127

German Center for Neurodegenerative Diseases (DZNE), Bonn

60611

Northwestern University, Chicago

67098

CHU Strasbourg Hpital Hautepierre, Strasbourg

77030

The University of Texas Health Science Center at Houston, Houston

80113

CenExel Rocky Mountain Clinical Research, LLC, Englewood

84416

kbo - Isar-Amper-Klinikum Taufkirchen, Taufkirchen

85013

Barrow Neurological Institute, Phoenix

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie, Erlangen

94010

Hopital Henri Mondor, Créteil

95817

University of California Davis Medical System, Sacramento

98034

EvergreenHealth Investigational Drug Services, Kirkland

99202

Inland Northwest Research, Spokane

02215

Beth Israel Deaconess Medical Center, Boston

C1056ABI

CINME, Buenos Aires

C1221ADC

Hospital Ramos Mejía, CABA

C1192AAX

INEBA, Capital Federal

C1284AEB

Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires

T6G 2G3

University of Alberta Hospital, Edmonton

H3A 2B4

Montreal Neurological Inst, Montreal

DUMMY_VALUE

Hopital Roger Salengro Service de Neurologie, Lille

00189

Azienda Ospedaliera Sant'Andrea, Rome

80-462

Szpital Sw. Wojciecha, Gdansk

31-505

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K, Krakow

01-755

Wojskowy Instytut Medycyny Lotniczej, Warsaw

1649-035

Hospital de Santa Maria, Lisbon

2560-280

CNS - Campus Neurológico, Torres Vedras

06080

Hospital Universitario de Badajoz, Badajoz

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

09006

Hospital Universitario de Burgos. Servicio de Neurología, Burgos

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

CB2 0QQ

Addenbrookes Hospital, Cambridge

LS7 4SA

Chapel Allerton Hospital, Leeds

NW1 2PG

UCL Hospital NHS Trust, London

OX3 9DU

John Radcliffe Hospital, Oxford

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT05686551 - 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 | Biotech Hunter | Biotech Hunter