Genetic Study of Amyotrophic Lateral Sclerosis in Norway (GAIN)

May 18, 2026 updated by: Sykehuset Telemark

Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn.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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Bergen, Norway
        • Recruiting
        • Haukeland University Hospital, Department of Neurology
        • Contact:
          • Ole-Bjørn Tysnes
      • Bodø, Norway
        • Recruiting
        • Nordland Hospital Trust, Department of Neurology
        • Contact:
          • Karl Bjørnar Alstadhaug
      • Drammen, Norway
        • Recruiting
        • Vestre Viken Hospital Trust, Department of Neurology
        • Contact:
          • Ingrid Kristine Bjørnå
      • Førde, Norway
        • Recruiting
        • Førde Hospital Trust, Department of Neurology
        • Contact:
          • Elin Seim
      • Grålum, Norway
        • Recruiting
        • Østfold Hospital Trust, Department of Neurology
        • Contact:
          • Erika Hallerstig
          • Phone Number: 004769865000
      • Haugesund, Norway
        • Recruiting
        • Fonna Hospital Trust, Department of Neurology
        • Contact:
          • Ineke HogenEsch
      • Kristiansand, Norway
        • Recruiting
        • Sørlandet Hospital Trust, Department of Neurology
        • Contact:
          • Unn Ljøstad
      • Lillehammer, Norway
        • Recruiting
        • Innlandet Hospital Trust, Department of Neurology
        • Contact:
          • Grethe Kleveland
      • Lørenskog, Norway
        • Recruiting
        • Akershus University Hospital, Department of Neurology
        • Contact:
          • Trygve Holmøy
      • Molde, Norway
        • Recruiting
        • Møre and Romsdal Hospital Trust, Department of Neurology
        • Contact:
          • Åse Hagen Morsund
      • Namsos, Norway
        • Recruiting
        • Nord-Trøndelag Hospital Trust, Department of Neurology
        • Contact:
          • Anna Grav
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital, Department of Neurology
        • Contact:
          • Angelina Maniaol
      • Skien, Norway
        • Recruiting
        • Telemark Hospital, Department of Neurology
        • Contact:
          • Heidi Flemmen
      • Stavanger, Norway
        • Recruiting
        • Stavanger University Hospital, Department of Neurology
        • Contact:
          • Katrin Schlüter
      • Tromsø, Norway
        • Recruiting
        • University hospital of North Norway, Department of Neurology
        • Contact:
          • Agnethe Eltoft
        • Contact:
          • Gudveig Lunde Toverud
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital, Department of Neurology
        • Contact:
          • Geir Bråthen
        • Sub-Investigator:
          • Helene Ballo Kvernmo
      • Tønsberg, Norway
        • Recruiting
        • Vestfold Hospital Trust, Department of Neurology
        • Contact:
          • Natasha Demic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with ALS that are being followed through the Norwegian health-care system.

Description

Inclusion Criteria:

  • Probable or definite ALS
  • Eligible to consent

Exclusion Criteria:

- not competent to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals diagnosed with ALS
Individuals diagnosed with ALS that are being followed through the Norwegian health-care system. ALS patients ( probable or definite per El-Escorial criteria)
Other: Observation
Observation of genetic characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene frequency
Time Frame: 2020-2030
Number of patients with disease causing mutations in high penetrant ALS genes
2020-2030
New ALS genes
Time Frame: 2024-2030
Identify new ALS genes in the Norwegian ALS population
2024-2030
Genetic risk factors
Time Frame: 2022-2030
Identify genetic risk factors for ALS in Norway.
2022-2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Collaborators

Helse Sor-Ost
ALS Norge

Investigators

  • Principal Investigator: Helle Høyer, Telemark Hospital Trust, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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