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NCT05119387 Clinical Trial

Genetic Study of Amyotrophic Lateral Sclerosis in Norway

Amyotrophic Lateral Sclerosis Clinical Trial

— GAIN  

Official title:
Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05119387
Other study ID # 2018/1916
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2030

Study information
Verified date July 2022
Source Sykehuset Telemark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.

Description:

After being informed about the study and potential risks, all patients giving written informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn. Blood samples, questionnaires, clinical information and signed consent is send to Department of Medical Genetics, Telemark Hospital Trust were the genetic analysis is performed successively throughout the recruitment period. Patients can choose to have their genetic results returned in a diagnostic setting.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 31, 2030
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Probable or definite ALS - Eligible to consent Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observation of genetic characteristics

Locations
Country Name City State
Norway Haukeland University Hospital, Department of Neurology Bergen
Norway Nordland Hospital Trust, Department of Neurology Bodø
Norway Vestre Viken Hospital Trust, Department of Neurology Drammen
Norway Førde Hospital Trust, Department of Neurology Førde
Norway Østfold Hospital Trust, Department of Neurology Grålum
Norway Fonna Hospital Trust, Department of Neurology Haugesund
Norway Sørlandet Hospital Trust, Department of Neurology Kristiansand
Norway Innlandet Hospital Trust, Department of Neurology Lillehammer
Norway Akershus University Hospital, Department of Neurology Lørenskog
Norway Møre and Romsdal Hospital Trust, Department of Neurology Molde
Norway Nord-Trøndelag Hospital Trust, Department of Neurology Namsos
Norway Oslo University Hospital, Department of Neurology Oslo
Norway Telemark Hospital, Department of Neurology Skien
Norway Stavanger University Hospital, Department of Neurology Stavanger
Norway Vestfold Hospital Trust, Department of Neurology Tønsberg
Norway University hospital of North Norway, Department of Neurology Tromsø
Norway St. Olavs Hospital, Department of Neurology Trondheim

Sponsors (3)
Lead Sponsor Collaborator
Sykehuset Telemark ALS Norge, Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gene frequency Number of patients with disease causing mutations in high penetrant ALS genes 2020-2023
Primary Genetic risk factors Identify genetic risk factors for ALS in Norway. 2022-2025
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