NUSINERSEN ( DrugBank: Nusinersen )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 3 | 脊髄性筋萎縮症 | 65 |
3. 脊髄性筋萎縮症
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
Showing 1 to 10 of 65 diseases
| 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 | NCT05386680 (ClinicalTrials.gov) | January 12, 2023 | 18/5/2022 | Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 A ... | Phase IIIb, Open-label, Single-arm, Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally (1.2 x 10^14 Vector Genomes) to Participants 2 to 12 Years of Age With Spinal Muscular Atrophy (SMA) Who Have Discontinued Treatment With Nusinersen (Spinraza®) or Risdiplam (Evrysdi®) Phase IIIb, Open-label, Single-arm, Multi-center Study to Evaluate the Safety, Tolerability and Effi ... | Spinal Muscular Atrophy | Genetic: OAV101 | Novartis Pharmaceuticals | NULL | Recruiting | 2 Years | 12 Years | All | 28 | Phase 3 | Canada;Japan;Netherlands;Spain |
| 2 | NCT05522361 (ClinicalTrials.gov) | September 15, 2022 | 24/5/2022 | Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen | Risdiplam Exchange in Patients With Spinal Muscular Atrophy (SMA) Previously and Exclusively Treated With Nusinersen Risdiplam Exchange in Patients With Spinal Muscular Atrophy (SMA) Previously and Exclusively Treated ... | Spinal Muscular Atrophy | Drug: Risdiplam | Clinic for Special Children | Genentech, Inc. | Not yet recruiting | 2 Years | 35 Years | All | 10 | Phase 4 | United States |
| 3 | JPRN-jRCT2031220035 | 26/05/2022 | 23/04/2022 | Long-Term Extension Study of Nusinersen in Participants With SMA | A 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 A Long-Term Extension Study of Nusinersen(BIIB058) Administered at Higher Doses in Participants With ... | Spinal muscular atrophy | Research Name: BIIB058 Generic Name: nusinersen Trade Names: Spinraza Participants in Study 203 who received maintenance doses of 28 mg nusinersen every 4 months will continue this dosing scheme in Study 302. Those who received the currently approved maintenance dose of 12 mg nusinersen in Study 203 will be administered a bolus dose of 50 mg nusinersen on Day 1 followed by 28 mg nusinersen maintenance doses every 4 months thereafter, which is identical to the regimen in Part C of Study 203. Research Name: BIIB058 Generic Name: nusinersen Trade Names: Spinraza Participants in Study 203 who rec ... | Irzhevsky Victoria | NULL | Pending | Not applicable | Not applicable | Both | 172 | Phase 3 | United States;Canada;Estonia;Hungary;Ireland;Italy;Latvia;Poland;Spain;Taiwan;France;Germany;Greece;Australia;South Korea;United Kingdom;Israel;Lebanon;Russia;Turkey;Japan United States;Canada;Estonia;Hungary;Ireland;Italy;Latvia;Poland;Spain;Taiwan;France;Germany;Greece; ... |
| 4 | EUCTR2019-002663-10-NL (EUCTR) | 13/05/2022 | 05/02/2022 | Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy | Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy - Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Escalating Dose and Randomized, Controlled Study of Nusinersen(BIIB058) in Participants With Spinal ... | 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] Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ... | 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 Trade Name: Spinraza INN or Proposed INN: Nusinersen Other descriptive name: NUSINERSENSODIUM Product N ... | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 172 | Phase 2;Phase 3 | United 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 United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ireland;Lebanon;Chile;Israel;Russian Federati ... | ||
| 5 | EUCTR2021-005314-34-ES (EUCTR) | 11/05/2022 | 09/03/2022 | Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or Risdiplam Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with L ... | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab ( ... | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spi ... | Product Name: Apitegromab Product Code: SRK-015 INN or Proposed INN: Apitegromab | Scholar Rock, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | France;United States;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2020-004708-32-DE (EUCTR) | 05/04/2022 | 18/11/2021 | Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen Extension Study of Nusinersen(BIIB058) in Participants With Spinal Muscular Atrophy Who Previously P ... | A 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 A Long-Term Extension Study of Nusinersen(BIIB058) Administered at Higher Doses in Participants With ... | 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] Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ... | 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 Product Name: Nusinersen Product Code: ISIS 396443, BIIB058 INN or Proposed INN: NUSINERSEN Other descr ... | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 152 | Phase 3 | United 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 United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Lebanon;Ireland;Chile;Israel;Russian Federati ... | ||
| 7 | JPRN-jRCT2051210186 | 31/03/2022 | 03/03/2022 | Study of Nusinersen Among Patients with Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec Study of NusinersenAmong Patients with Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec ... | A Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec A Phase 4 Study of Nusinersen(BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onas ... | Spinal muscular atrophy (SMA) | Research Name: BIIB058 Generic Name: Nusinersen Trade Name: Spinraza Participants will undergo a loading period during which they will receive 12 mg nusinersen administered IT on Days 1,15, 29, and 64, followed by a maintenance period during which the participants will receive 12 mg nusinersen IT every 4 months. Research Name: BIIB058 Generic Name: Nusinersen Trade Name: Spinraza Participants will undergo a loadin ... | Nagamine Satoshi | NULL | Pending | >= 2month old | <= 36month old | Both | 60 | Phase 4 | United States;Italy;Spain;Israel;Germany;Japan |
| 8 | EUCTR2021-001294-23-ES (EUCTR) | 31/03/2022 | 20/12/2021 | A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with Risdiplam A Study to Evaluate Higher Dose (HD) Nusinersen(BIIB058) in Participants with Spinal Muscular Atroph ... | A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam A Phase 3b Study to Evaluate Higher Dose Nusinersen(BIIB058) in Patients with Spinal Muscular Atroph ... | 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] Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ... | 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 descr ... | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 3 | Canada;Poland;Brazil;Belgium;Spain;Australia;Germany;Italy;Switzerland;Japan | ||
| 9 | EUCTR2021-001294-23-IT (EUCTR) | 25/02/2022 | 17/12/2021 | A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrophy Previously Treated with Risdiplam A Study to Evaluate Higher Dose (HD) Nusinersen(BIIB058) in Participants with Spinal Muscular Atroph ... | A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam - . A Phase 3b Study to Evaluate Higher Dose Nusinersen(BIIB058) in Patients with Spinal Muscular Atroph ... | 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] Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ... | 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 Trade Name: Spinraza Product Name: .Nusinersen Product Code: [ ISIS 396443, BIIB058] Other descriptive ... | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 3 | Canada;Spain;Poland;Brazil;Belgium;Australia;Germany;Switzerland;Japan;Italy | ||
| 10 | NCT05156320 (ClinicalTrials.gov) | February 24, 2022 | 1/12/2021 | Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With ... | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab ( ... | Spinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscular Diseases;Muscular Atrophy;Atrophy;Muscular Atrophy, Spinal;Neuromuscular Manifestations;Anti-myostatin Spinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscu ... | Drug: Apitegromab;Drug: Placebo | Scholar Rock, Inc. | NULL | Recruiting | 2 Years | 21 Years | All | 204 | Phase 3 | Germany;Italy;Netherlands;Poland;Spain;United Kingdom;Belgium;France;United States |