DDrare: Database of Drug Development for Rare Diseases

8. ハンチントン病
［臨床試験数：197，薬物数：171（DrugBank：54），標的遺伝子数：82，標的パスウェイ数：144］

Searched query = "Huntington disease", "Huntington chorea"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (2)-epigallocatechin-3-gallate (EGCG); 20 mg BID of PF-02545920; 20mg daily citalopram; 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium; ACR16; ACR16 10 mg; ACR16 22.5 mg; ACR16 45 mg; ACR16 hydrochloride, ASP2314 hydrochloride, FR310826; AFQ056; ANX005; Alprazolam; Amantadine; Anti-Parkinson medication; Atomoxetine; Autologous Stem Cell; BEVANTOLOL HYDROCHLORIDE; BN82451B; BN8251B; Bevantolol; Biotin; Blood sample; Bupropion; CBD; CKD-504; CYSTAGON; Calvan® 100 mg; Cannabidiol; Cellavita HD Higher dose; Cellavita HD Lower Dose; Cellavita HD higher dose; Cellavita HD lower dose; Cellavita-HD; Citalopram; CoQ10; Coenzyme Q10; Creatine; Creatine Monohydrate; Creatine monohydrate; Cystagon; Cysteamine; Cysteamine Bitartrate; DM; Delta-9-tetrahydrocannabinol; Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); Deutetrabenazine; Deutetrabenazine Oral Tablet [Austedo]; Device: BioStamp nPoint device; Device: Deep Brain Stimulation; Dextromethorphan; Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg); Digoxin; Dimebon; Dimebon (latrepirdine); Dimebon + Dextromethorphan; Dimebon + Ketoconazole; Dimebon + Omeprazole; Dimebon Dihydrochloride; Dimebon IR; Dimebon IR Tablet; Dimebon MR1; Dimebon MR2; Dimebon MR3; Dimebon MR4; Dimebon Transdermal; Dimebon alone; Dimebon dihydrochloride; Divalproex; EGCG; EPA; Epigallocatechin; Ethyl Icosapent; Ethyl-EPA; Ethyl-EPA (Miraxion™); Ethyl-Icosapent; Fenofibrate; GSK356278; Graft intracerebral of foetal neurons; HYPERIUM; Haloperidol; High doses of Thiamine y Biotin; Hyperium; ISIS 443139 10 mg; ISIS 443139 120 mg; ISIS 443139 30 mg; ISIS 443139 60 mg; ISIS 443139 90 mg; Icosapent; Ketoconazole; LAQUINIMOD; LAX-101; Laquinimod; Laquinimod capsules 0.5 mg; Latrepirdine; Lithium; Melatonin; Memantine; Minocycline; Moderate doses of Thiamine y Biotin; N.a.; Neflamapimod; Nilotinib; Nilotinib 150 MG; OMS643762; OSU6162 similar to (-)-OSU 6162; Olanzapine; Omeprazole; Other: 31-Phosphorus RMN Spectroscopy; PBF-999; PBF-999 / 160 mg; PBF-999 / 320 mg; PBT2; PF-02545920; PL101; PRIDOPIDINE HYDROCHLORIDE; Phenylbutyrate; Phosphorus; Pridiopidine; Pridopidina; Pridopidine; Pridopidine (90 mg); Quinidine; RG6042, formerly ISIS 443139, IONIS-HTTRx; RO7234292; RO7234292 (RG6042); RP 103; RP103; Ramelteon; Resveratrol; Rilmenidine; Riluzole; Risperidone; Ro 723-4292/F02; Rolipram; SAGE-718; SBT-020; SD-809; SEN0014196; SEN0014196 (High Dose); SEN0014196 (Low Dose); SOM3355 100mg BID; SOM3355 200mg BID; SRX246; SS-20; Selisistat; Sodium phenylbutyrate; THC; TV-5600; TV-7820; Tetrabenazine; Tetrabenazine withdrawal; Tetrahydrocannabinol; Thiamine; Tiapridal; Tominersen; Triheptanoin; Triheptanoin 1g/kg/day; Triheptanoin oil; UX007; Ubiquinol; Ursodiol; VX-745; VX15/2503; Valbenazine; WVE-120101; WVE-120102; Warfarin; Xenazine; Zoloft; [123I]MNI-420; [18F]FPEB

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-003898-94-NL (EUCTR)	01/10/2020	08/10/2020	An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease	AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: Ro 723-4292/F02 INN or Proposed INN: tominersen Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx	F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1050	Phase 3	United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
2	NCT04000594 (ClinicalTrials.gov)	September 2, 2019	26/6/2019	A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease	An Open-Label, Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease	Huntingtons Disease	Drug: RO7234292 (RG6042)	Hoffmann-La Roche	NULL	Recruiting	25 Years	65 Years	All	20	Phase 1	Netherlands;United Kingdom
3	EUCTR2018-002987-14-NL (EUCTR)	23/07/2019	25/02/2019	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease	A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
4	EUCTR2018-003898-94-ES (EUCTR)	21/06/2019	11/06/2019	An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease	AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
5	NCT03842969 (ClinicalTrials.gov)	April 23, 2019	11/2/2019	An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Patients Who Participated in Prior Roche and Genentech Sponsored Studies	An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's Disease	Huntington Disease	Drug: RO7234292 (RG6042)	Hoffmann-La Roche	NULL	Recruiting	25 Years	N/A	All	1100	Phase 3	United States;Argentina;Australia;Austria;Canada;Germany;Italy;Netherlands;Spain;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-002987-14-DK (EUCTR)	11/04/2019	15/02/2019	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease	A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	United States;Spain;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Canada;Argentina;Poland;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;China
7	EUCTR2018-002987-14-AT (EUCTR)	27/03/2019	22/03/2019	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease	A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
8	EUCTR2018-002987-14-PL (EUCTR)	19/03/2019	07/04/2020	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease	A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx	F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
9	EUCTR2018-003898-94-GB (EUCTR)	07/03/2019	13/12/2018	An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease	AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: Ro 723-4292/F02 INN or Proposed INN: tominersen Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx	F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
10	EUCTR2018-002987-14-GB (EUCTR)	13/02/2019	08/02/2019	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease	A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE	Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		F.Hoffmann La-Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT03761849 (ClinicalTrials.gov)	January 23, 2019	30/11/2018	A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease	Huntingtons Disease	Drug: RO7234292;Drug: Placebo	Hoffmann-La Roche	NULL	Active, not recruiting	25 Years	65 Years	All	909	Phase 3	United States;Argentina;Australia;Austria;Canada;Chile;Denmark;France;Germany;Italy;Japan;Netherlands;New Zealand;Poland;Russian Federation;Spain;Switzerland;United Kingdom;China
12	EUCTR2017-002471-25-GB (EUCTR)	18/10/2018	04/08/2017	An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292	AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7234292 (ISIS 443139) IN HUNTINGTON'S DISEASE PATIENTS WHO PARTICIPATED IN PRIOR INVESTIGATIONAL STUDIES OF RO7234292 (ISIS 443139)	Early Manifest Huntington's Disease MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: Ro 723-4292/F02 INN or Proposed INN: n.a. Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx	F.Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	46	Phase 1;Phase 2	Canada;Germany;United Kingdom
13	EUCTR2017-002471-25-DE (EUCTR)	10/01/2018	07/08/2017	An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292	An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington’s Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)	Early Manifest Huntington's Disease MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: Ro 723-4292/F02 INN or Proposed INN: n.a. Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx	F.Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	46	Phase 2	Canada;Germany;United Kingdom
14	NCT03342053 (ClinicalTrials.gov)	November 27, 2017	31/10/2017	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)	An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)	Huntington's Disease	Drug: RO7234292 (RG6042)	Hoffmann-La Roche	NULL	Completed	25 Years	N/A	All	46	Phase 2	Canada;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003898-94-NL
(EUCTR)

01/10/2020

08/10/2020

An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1050

Phase 3

United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand

NCT04000594
(ClinicalTrials.gov)

September 2, 2019

26/6/2019

A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease

An Open-Label, Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease

Huntingtons Disease

Drug: RO7234292 (RG6042)

Hoffmann-La Roche

NULL

Recruiting

25 Years

65 Years

All

Phase 1

Netherlands;United Kingdom

EUCTR2018-002987-14-NL
(EUCTR)

23/07/2019

25/02/2019

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand

EUCTR2018-003898-94-ES
(EUCTR)

21/06/2019

11/06/2019

An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand

NCT03842969
(ClinicalTrials.gov)

April 23, 2019

11/2/2019

An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Patients Who Participated in Prior Roche and Genentech Sponsored Studies

An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's Disease

Huntington Disease

Drug: RO7234292 (RG6042)

Hoffmann-La Roche

NULL

Recruiting

25 Years

N/A

All

1100

Phase 3

United States;Argentina;Australia;Austria;Canada;Germany;Italy;Netherlands;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-002987-14-DK
(EUCTR)

11/04/2019

15/02/2019

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Spain;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Canada;Argentina;Poland;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;China

EUCTR2018-002987-14-AT
(EUCTR)

27/03/2019

22/03/2019

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand

EUCTR2018-002987-14-PL
(EUCTR)

19/03/2019

07/04/2020

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease

Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand

EUCTR2018-003898-94-GB
(EUCTR)

07/03/2019

13/12/2018

An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE

Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand

EUCTR2018-002987-14-GB
(EUCTR)

13/02/2019

08/02/2019

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease

Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

F.Hoffmann La-Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03761849
(ClinicalTrials.gov)

January 23, 2019

30/11/2018

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

Huntingtons Disease

Drug: RO7234292;Drug: Placebo

Hoffmann-La Roche

NULL

Active, not recruiting

25 Years

65 Years

All

909

Phase 3

United States;Argentina;Australia;Austria;Canada;Chile;Denmark;France;Germany;Italy;Japan;Netherlands;New Zealand;Poland;Russian Federation;Spain;Switzerland;United Kingdom;China

EUCTR2017-002471-25-GB
(EUCTR)

18/10/2018

04/08/2017

An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7234292 (ISIS 443139) IN HUNTINGTON'S DISEASE PATIENTS WHO PARTICIPATED IN PRIOR INVESTIGATIONAL STUDIES OF RO7234292 (ISIS 443139)

Early Manifest Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx

F.Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Canada;Germany;United Kingdom

EUCTR2017-002471-25-DE
(EUCTR)

10/01/2018

07/08/2017

An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington’s Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)

Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx

F.Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Canada;Germany;United Kingdom

NCT03342053
(ClinicalTrials.gov)

November 27, 2017

31/10/2017

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)

An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)

Huntington's Disease

Drug: RO7234292 (RG6042)

Hoffmann-La Roche

NULL

Completed

25 Years

N/A

All

Phase 2

Canada;Germany;United Kingdom