3. 脊髄性筋萎縮症 Spinal muscular atrophy Clinical trials / Disease details


臨床試験数 : 237 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75

  
25 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002663-10-NL
(EUCTR)
13/05/202205/02/2022Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
172Phase 2;Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan
2EUCTR2020-004708-32-DE
(EUCTR)
05/04/202218/11/2021Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Lebanon;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan
3EUCTR2021-001294-23-ES
(EUCTR)
31/03/202220/12/2021A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with RisdiplamA Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 3Canada;Poland;Brazil;Belgium;Spain;Australia;Germany;Italy;Switzerland;Japan
4EUCTR2021-001294-23-IT
(EUCTR)
25/02/202217/12/2021A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with RisdiplamA Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam - . Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
Product Name: .Nusinersen
Product Code: [ ISIS 396443, BIIB058]
Other descriptive name: NUSINERSEN SODIUM
Trade Name: Spinraza
Product Name: Nusinersen
Product Code: [ ISIS 396443, BIIB058]
Other descriptive name: NUSINERSEN SODIUM
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 3Canada;Spain;Poland;Brazil;Belgium;Australia;Germany;Switzerland;Japan;Italy
5EUCTR2020-004708-32-HU
(EUCTR)
15/06/202117/04/2021Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 3United States;Taiwan;Saudi Arabia;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
6EUCTR2020-003492-18-DE
(EUCTR)
07/06/202118/03/2021A Study of Nusinersen Among Participants With Spinal Muscular Atrophy Who Received Onasemnogene AbeparvovecA Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4United States;Spain;Israel;Germany;Italy
7EUCTR2020-003492-18-ES
(EUCTR)
02/06/202101/09/2021A Study of Nusinersen Among Participants With Spinal Muscular Atrophy Who Received Onasemnogene AbeparvovecA Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4United States;Spain;Israel;Germany;Italy
8EUCTR2020-004708-32-ES
(EUCTR)
05/05/202109/02/2021Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 3United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
9EUCTR2020-003492-18-IT
(EUCTR)
26/04/202108/06/2021A Study of Nusinersen Among Participants With Spinal Muscular Atrophy Who Received Onasemnogene AbeparvovecA Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Spinraza
Product Name: .
Product Code: [.]
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4United States;Spain;Israel;Germany;Italy
10EUCTR2019-002663-10-DE
(EUCTR)
18/02/202123/10/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 2;Phase 3United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
11EUCTR2019-002663-10-FR
(EUCTR)
23/12/202023/10/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 2;Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
12EUCTR2019-002663-10-GB
(EUCTR)
17/12/202001/09/2020Study of Nusinersen (BIIB058) in Participants With Spinal MuscularAtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen(BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
Product Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nursinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: Nursinersen
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 2;Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Israel;Chile;Russian Federation;Colombia;Italy;Australia;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
13EUCTR2019-002663-10-ES
(EUCTR)
06/05/202010/05/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2;Phase 3United States;Saudi Arabia;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Chile;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Australia;Latvia;Korea, Republic of
14EUCTR2019-002663-10-HU
(EUCTR)
23/04/202005/03/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2;Phase 3United States;Saudi Arabia;Estonia;Spain;Ireland;Lebanon;Russian Federation;Chile;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Australia;Latvia;Korea, Republic of
15EUCTR2019-002663-10-LV
(EUCTR)
27/03/202012/02/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2;Phase 3United States;Saudi Arabia;Estonia;Spain;Ireland;Lebanon;Russian Federation;Chile;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Australia;Latvia;Korea, Republic of
16EUCTR2019-002663-10-IT
(EUCTR)
05/03/202017/06/2021Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: [ ISIS 396443, BIIB058]
Other descriptive name: NUSINERSEN SODIUM
Trade Name: Spinraza
Product Name: Nusinersen
Product Code: [ISIS 396443, BIIB058]
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 2;Phase 3United States;Taiwan;Saudi Arabia;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
17EUCTR2020-004708-32-PL
(EUCTR)
21/12/2021Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
152Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Lebanon;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan
18EUCTR2019-002663-10-PL
(EUCTR)
11/03/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
172Phase 2;Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan
19EUCTR2021-001294-23-PL
(EUCTR)
20/04/2022A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with RisdiplamA Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
135Phase 3Canada;Spain;Belgium;Brazil;Poland;Australia;Germany;Italy;Switzerland;Japan
20EUCTR2019-002663-10-GR
(EUCTR)
02/11/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
152Phase 2;Phase 3Canada;Argentina;Brazil;Poland;Germany;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Latvia;Korea, Republic of;Turkey;Hungary;Mexico
21EUCTR2021-001294-23-BE
(EUCTR)
16/12/2021A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with RisdiplamA Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
135Phase 3Canada;Spain;Poland;Brazil;Belgium;Australia;Germany;Switzerland;Japan
22EUCTR2019-002663-10-IE
(EUCTR)
04/03/2020Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyEscalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Spinraza
INN or Proposed INN: Nusinersen
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
172Phase 2;Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Germany
23EUCTR2020-004708-32-NL
(EUCTR)
06/01/2023Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
172Phase 3United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Netherlands;Latvia;China;Korea, Republic of;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan;Turkey
24EUCTR2021-001294-23-DE
(EUCTR)
27/12/2021A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Previously Treated With RisdiplamA Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients With Spinal Muscular Atrophy Previously Treated With Risdiplam Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
135Phase 3Canada;Belgium;Spain;Poland;Brazil;Australia;Germany;Italy;Switzerland;Japan
25EUCTR2020-004708-32-EE
(EUCTR)
02/02/2021Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With NusinersenA Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD Muscular Atrophy, Spinal
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Product Name: Nusinersen
Product Code: ISIS 396443, BIIB058
INN or Proposed INN: NUSINERSEN
Other descriptive name: NUSINERSEN SODIUM
Biogen Idec Research LimitedNULLNAFemale: yes
Male: yes
152Phase 3United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Germany;Japan