Amyotrophic Lateral SclerosisGAINNCT05119387
Genetic Study of Amyotrophic Lateral Sclerosis in Norway
An observational study of Amyotrophic Lateral Sclerosis, run by Sykehuset Telemark at 17 sites in Norway.
Trial summary
The purpose of this study is to explore the genetic causes relevant for ALS development in Norway. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Observation
- How many people
- 1,200 participants
- Where
- 17 sitesNorway
- Study dates
- 1 Aug 2019to 31 Dec 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals diagnosed with ALS that are being followed through the Norwegian health-care system.
Who may be able to join
- Probable or definite ALS
- Eligible to consent
Who cannot join
- not competent to give consent
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Norway17 sites, 17 recruiting
- Recruiting
Haukeland University Hospital, Department of Neurology
Bergen
Ole-Bjørn Tysnes
- Recruiting
Nordland Hospital Trust, Department of Neurology
Bodø
Karl Bjørnar Alstadhaug
- Recruiting
Vestre Viken Hospital Trust, Department of Neurology
Drammen
Ingrid Kristine Bjørnå
- Recruiting
Førde Hospital Trust, Department of Neurology
Førde
Elin Seim
- Recruiting
Østfold Hospital Trust, Department of Neurology
Grålum
Erika Hallerstig, 004769865000
- Recruiting
Fonna Hospital Trust, Department of Neurology
Haugesund
Ineke HogenEsch
- Recruiting
Sørlandet Hospital Trust, Department of Neurology
Kristiansand
Unn Ljøstad
- Recruiting
Innlandet Hospital Trust, Department of Neurology
Lillehammer
Grethe Kleveland
- Recruiting
Akershus University Hospital, Department of Neurology
Lørenskog
Trygve Holmøy
- Recruiting
Møre and Romsdal Hospital Trust, Department of Neurology
Molde
Åse Hagen Morsund
- Recruiting
Nord-Trøndelag Hospital Trust, Department of Neurology
Namsos
Anna Grav
- Recruiting
Oslo University Hospital, Department of Neurology
Oslo
Angelina Maniaol
- Recruiting
Telemark Hospital, Department of Neurology
Skien
Heidi Flemmen
- Recruiting
Stavanger University Hospital, Department of Neurology
Stavanger
Katrin Schlüter
- Recruiting
Vestfold Hospital Trust, Department of Neurology
Tønsberg
Natasha Demic
- Recruiting
University hospital of North Norway, Department of Neurology
Tromsø
Agnethe Eltoft
Gudveig Lunde Toverud
- Recruiting
St. Olavs Hospital, Department of Neurology
Trondheim
Geir Bråthen
Helene Ballo Kvernmo
About this study
Official title: Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)
The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Observation
- Keywords
- Genetics, Amyotrophic Lateral Sclerosis, Neurology, Clinical genetics
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of genetic characteristics
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene frequency
Number of patients with disease causing mutations in high penetrant ALS genes
Measured: 2020-2030
New ALS genes
Identify new ALS genes in the Norwegian ALS population
Measured: 2024-2030
Genetic risk factors
Identify genetic risk factors for ALS in Norway.
Measured: 2022-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Aug 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- ALS Norge, Helse Sor-Ost
- Responsible party
- Sponsor
- Investigators
- Helle Høyer, Principal investigator, Telemark Hospital Trust, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119387
- Sponsor's protocol ID
- 2018/1916
- Acronym
- GAIN
- Status last verified
- May 2026
- First submitted
- 2 Nov 2021
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)
- ClinicalTrials.gov ID
- NCT05119387
- Acronym / sponsor ID
- GAIN / 2018/1916
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Genetics, Amyotrophic Lateral Sclerosis, Neurology, Clinical genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- ALS Norge, Helse Sor-Ost
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with ALS | – | Other: ObservationIndividuals diagnosed with ALS that are being followed through the Norwegian health-care system. ALS patients ( probable or definite per El-Escorial criteria) |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals diagnosed with ALS that are being followed through the Norwegian health-care system.
Key inclusion criteria (2 listed)
- Probable or definite ALS
- Eligible to consent
Key exclusion criteria (1 listed)
- not competent to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation of genetic characteristics | Other | Individuals diagnosed with ALS |
Primary outcome
Gene frequency
Time frame: 2020-2030
Number of patients with disease causing mutations in high penetrant ALS genes
New ALS genes
Time frame: 2024-2030
Identify new ALS genes in the Norwegian ALS population
Genetic risk factors
Time frame: 2022-2030
Identify genetic risk factors for ALS in Norway.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helle Høyer principal investigator
Telemark Hospital Trust, Norway
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Sykehuset Telemark at 17 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helle Høyer (35003146 ext. 0047, helle.hoyer@sthf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene frequency (time frame: 2020-2030). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.