NCT05119387

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Aug 2019Dec 2035

Study Start

First participant enrolled

August 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

11.4 years

First QC Date

November 2, 2021

Last Update Submit

January 6, 2025

Conditions

Keywords

GeneticsAmyotrophic Lateral SclerosisNeurologyClinical genetics

Outcome Measures

Primary Outcomes (3)

  • Gene frequency

    Number of patients with disease causing mutations in high penetrant ALS genes

    2020-2030

  • New ALS genes

    Identify new ALS genes in the Norwegian ALS population

    2024-2030

  • Genetic risk factors

    Identify genetic risk factors for ALS in Norway.

    2022-2030

Study Arms (1)

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

Interventions

Observation of genetic characteristics

Individuals diagnosed with ALS

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Probable or definite ALS
  • Eligible to consent

You may not qualify if:

  • \- not competent to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Haukeland University Hospital, Department of Neurology

Bergen, Norway

RECRUITING

Nordland Hospital Trust, Department of Neurology

Bodø, Norway

RECRUITING

Vestre Viken Hospital Trust, Department of Neurology

Drammen, Norway

RECRUITING

Førde Hospital Trust, Department of Neurology

Førde, Norway

RECRUITING

Østfold Hospital Trust, Department of Neurology

Grålum, Norway

RECRUITING

Fonna Hospital Trust, Department of Neurology

Haugesund, Norway

RECRUITING

Sørlandet Hospital Trust, Department of Neurology

Kristiansand, Norway

RECRUITING

Innlandet Hospital Trust, Department of Neurology

Lillehammer, Norway

RECRUITING

Akershus University Hospital, Department of Neurology

Lørenskog, Norway

RECRUITING

Møre and Romsdal Hospital Trust, Department of Neurology

Molde, Norway

RECRUITING

Nord-Trøndelag Hospital Trust, Department of Neurology

Namsos, Norway

RECRUITING

Oslo University Hospital, Department of Neurology

Oslo, Norway

RECRUITING

Telemark Hospital, Department of Neurology

Skien, Norway

RECRUITING

Stavanger University Hospital, Department of Neurology

Stavanger, Norway

RECRUITING

University hospital of North Norway, Department of Neurology

Tromsø, Norway

RECRUITING

St. Olavs Hospital, Department of Neurology

Trondheim, Norway

RECRUITING

Vestfold Hospital Trust, Department of Neurology

Tønsberg, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Helle Høyer

    Telemark Hospital Trust, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helle Høyer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

August 1, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations