Actively Recruiting

All Genders
NCT04174157

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Led by Novartis Pharmaceuticals · Updated on 2025-01-31

700

Participants Needed

99

Research Sites

1031 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor neurons. SMA is an autosomal recessive, early childhood disease with an incidence of 1:10,000 live births. SMA is the leading cause of infant mortality due to genetic diseases. The purpose of this registry is to assess the long term outcomes of patients with SMA in the context of advances in treatment options and also to characterize and assess long-term safety and effectiveness of OAV-101.

CONDITIONS

Official Title

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients treated with OAV-101 with a genetically confirmed diagnosis of SMA regardless of the date of diagnosis
  • Appropriate consent or assent obtained for participation in the registry
  • Patients in Compassionate Use Programs for OAV-101 such as Managed Access Program, Expanded Access Program, Single Patient IND, or Named Patient Program are eligible regardless of diagnosis date
Not Eligible

You will not qualify if you...

  • Currently enrolled in an interventional clinical trial involving an investigational drug to treat SMA

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 99 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

3

Loma Linda University Health

Loma Linda, California, United States, 92350

Completed

4

Children's Hospital of Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

5

University of California Los Angeles Health

Los Angeles, California, United States, 90095

Actively Recruiting

6

Valley Children's Healthcare

Madera, California, United States, 93636

Actively Recruiting

7

Children's Hospital of Orange County

Madera, California, United States, 93638

Actively Recruiting

8

University of California Davis Health System

Sacramento, California, United States, 95817

Actively Recruiting

9

Rady Children's Hospital San Diego

San Diego, California, United States, 92123

Actively Recruiting

10

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

11

Connecticut Children's Medical Center

Farmington, Connecticut, United States, 06034

Actively Recruiting

12

Yale-New Haven Health System

New Haven, Connecticut, United States, 06510

Actively Recruiting

13

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States, 33908

Actively Recruiting

14

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Completed

15

Adventist Health System - Florida

Orlando, Florida, United States, 32803

Completed

16

Jackson South Medical Center

Palmetto Bay, Florida, United States, 33157

Actively Recruiting

17

Indiana University Health University Hospital (IUHUH)

Indianapolis, Indiana, United States, 46202

Actively Recruiting

18

University of Iowa

Iowa City, Iowa, United States, 52242-1009

Actively Recruiting

19

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

20

University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

21

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

22

University of Missouri Health System

Columbia, Missouri, United States, 65212

Actively Recruiting

23

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

24

Atlantic Health System

Morristown, New Jersey, United States, 07960

Actively Recruiting

25

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

26

The State University of New York

Stony Brook, New York, United States, 11794

Actively Recruiting

27

Duke Health

Durham, North Carolina, United States, 27705

Actively Recruiting

28

Akron Children's Hospital

Akron, Ohio, United States, 44308-1062

Completed

29

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229-3026

Actively Recruiting

30

University Hospitals

Cleveland, Ohio, United States, 44106

Completed

31

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

32

Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States, 73104

Completed

33

Oregon Health and Science University

Portland, Oregon, United States, 97239-3098

Actively Recruiting

34

Penn State Hershey

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

35

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

36

Prisma Health

Greenville, South Carolina, United States, 29615

Actively Recruiting

37

Methodist Le Bonheur Healthcare

Memphis, Tennessee, United States, 38103

Actively Recruiting

38

Child Neurology Consultants of Austin

Austin, Texas, United States, 78731

Completed

39

Children's Health

Dallas, Texas, United States, 75207

Completed

40

Cook Children's

Fort Worth, Texas, United States, 76104

Actively Recruiting

41

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

42

CHRISTUS Health

San Antonio, Texas, United States, 78207

Actively Recruiting

43

University of Utah

Salt Lake City, Utah, United States, 84113

Actively Recruiting

44

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Actively Recruiting

45

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States, 23507

Actively Recruiting

46

Virginia Commonwealth University Health System

Richmond, Virginia, United States, 23298

Actively Recruiting

47

Seattle Children's

Seattle, Washington, United States, 98105

Actively Recruiting

48

MultiCare Health System

Tacoma, Washington, United States, 98405

Actively Recruiting

49

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

50

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

51

University General Hospital Attikon

Chaïdári, Athens, Greece, 124 62

Actively Recruiting

52

Penteli Children's Hospital

Pentéli, Attikis, Greece, 152 36

Actively Recruiting

53

St. Sophia Children's Hospital

Thessaloniki, Greece, 115 27

Actively Recruiting

54

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece, 546 42

Actively Recruiting

55

Children's University Hospital-UCD School of Medicine Scoil an Leighis

Dublin, Ireland, 1 D01 XD99

Actively Recruiting

56

Soroka Medical Centre

Beersheba, Israel, 85025

Actively Recruiting

57

Wolfson Medical Center

Holon, Israel, 5822012

Actively Recruiting

58

Tel-Aviv Sourasky Medical Center

Holon, Israel, 582201

Actively Recruiting

59

Schneider- Children's Medical Center

Petah Tikva, Israel, 4920235

Actively Recruiting

60

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, Japan, 480-1195

Active, Not Recruiting

61

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, Japan, 470-1192

Active, Not Recruiting

62

Chiba children's Hospital

Chiba, Chiba, Japan, 266-0007

Active, Not Recruiting

63

Kurume University Hospital

Kurume-shi, Fukuoka, Japan, 830-0011

Active, Not Recruiting

64

Gifu Prefectural General Medical Center

Gifu, Gifu, Japan, 500-8717

Active, Not Recruiting

65

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan, 060-8543

Active, Not Recruiting

66

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan, 761-0793

Active, Not Recruiting

67

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan, 232-8555

Active, Not Recruiting

68

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan, 860-8556

Active, Not Recruiting

69

Miyagi Children's Hospital

Sendai, Miyagi, Japan, 989-3126

Active, Not Recruiting

70

Obihiro Kosei Hospital

Hokkaido, Obihiro-shi, Japan, 080-0024

Active, Not Recruiting

71

Shiga Medical Center for Children

Moriyama-shi, Shiga, Japan, 524-0022

Active, Not Recruiting

72

Hamamatsu University School of Medicine, University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Active, Not Recruiting

73

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan, 329-0498

Active, Not Recruiting

74

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan, 160-0023

Active, Not Recruiting

75

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, Japan, 162-8655

Active, Not Recruiting

76

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Active, Not Recruiting

77

Nikko Memorial Hospital

Hokkaido, Japan, 051-0005

Active, Not Recruiting

78

Dokkyo Medical University Saitama Medical Center

Saitama, Japan, 343-0845

Active, Not Recruiting

79

Uniwersytecki Szpital Dzieciec

Lublin, Poland, 20-093

Actively Recruiting

80

CHUC - Hospital Pediatrico

Coimbra, Portugal, 300-6020

Actively Recruiting

81

Centro Hospitalar Universitaria de Lisboa Central, EPE

Lisbon, Portugal, 1169-045

Actively Recruiting

82

Centro Hospitalar Universitario Lisboa Norte, EPE

Lisbon, Portugal, 1649-035

Actively Recruiting

83

Centro Hospitalar Universitario de Porto, EPE

Porto, Portugal, 4050-371

Actively Recruiting

84

Centro Hospitalar Universitario de Sao Joao, EPE

Porto, Portugal, 4200-319

Actively Recruiting

85

Centrul de Recuperare pentru Copii dr. Nicolae Robanescu

Bucharest, Romania, 041408

Actively Recruiting

86

Spitalul Clinic de Psihiatrie

Bucharest, Romania, 041914

Actively Recruiting

87

Almazov National Medical Research Centre

Saint Petersburg, Russia, 197341

Actively Recruiting

88

Kyungpook National University Hospital

Daegu, South Korea, 41944

Actively Recruiting

89

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Actively Recruiting

90

Seoul National University Children's Hospital

Seoul, South Korea, 03080

Actively Recruiting

91

Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

92

Samsung Medical Centre

Seoul, South Korea, 06351

Actively Recruiting

93

Pusan National University Yangsan Hospital

Yangsan, South Korea, 50612

Actively Recruiting

94

Yongin Severance Hospital

Yongin-si, South Korea, 16995

Actively Recruiting

95

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

Actively Recruiting

96

China Medical University Hospital

Taichung, Taiwan, 404327

Actively Recruiting

97

National Taiwan University Hospital

Taipei, Taiwan, 100229

Actively Recruiting

98

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

99

Chang Gung Memorial Hospital Linkou Branch

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

N

Novartis Gene Therapies

CONTACT

N

Novartis Gene Therapies

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA) | DecenTrialz