NCT02869048 Amyotrophic Lateral Sclerosis and the Innate Immune System
| NCT ID | NCT02869048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 375 participants |
| Start Date | 2016-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 375 participants in total. It began in 2016-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to destruction of the neural pathways which control the conscious movements of the muscles. This destruction leads to muscular dystrophy with increasing difficulties in moving, breathing, swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the time he or she gets the diagnose. The cause of the disease is still unknown and there is currently no treatment which can stop the progression of the disease. Former clinical studies have indicated that the innate immune system and in particular the complement system plays a significant role in the progression of ALS. The complement system, which is activated in cascades, is part of the innate system but participates in the innate as well as the acquired immune system. Former clinical trials have been characterized by limited knowledge about both the complement system as well as to how it is measured. Today it is possible to measure directly on the different components of the complement system and to understand its contribution to the overall immune response. It is also possible today to detect defects of the complement system. All these progressions are the foundation for this project which is carried out in close cooperation with one of the world's leading researchers in the complement system, professor Peter Garred from Rigshospitalet. The aim is to make a national research project about ALS in order to investigate the role of the innate immune system, and especially the complement system, in patients with ALS. In the long term the hope is, that this will lead the way to a targeted and effective medical treatment to the people affected by this grave disease.
Eligibility Criteria
Inclusion Criteria: * For ALS group:Diagnosed with the diagnose category "certain ALS" or "likely ALS according to the El Escorial rev. diagnose criteria * For Neurological control group: Referred to neurological department to be examined for acute or chronic headache or referred to get a lumbar perfusion test performed. Exclusion Criteria: * For all groups (Clinical study 2-3): permanent contraindication for having a lumbar puncture performed * For Neurological control group: Known with chronic inflammatory disease or autoimmune disease. * For healthy control group (clinical study 1): Known with any disease * For healthy control group (clinical study 1): Taking daily medication * For Neurologically healthy control group (Clinical study 2): Known with neurological disease * For Neurologically healthy control group (Clinical study 2): Known with chronic inflammatory disease or autoimmune disease.
Contact & Investigator
Anne-Lene Kjældgaard, MD
✉ akja004@regionh.dkKirsten Møller, Prof., MD
STUDY CHAIR
Clinic of Neuroanestesiology, Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT02869048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02869048 currently recruiting?
Yes, NCT02869048 is actively recruiting participants. Contact the research team at akja004@regionh.dk for enrollment information.
Where is the NCT02869048 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Brøndby, Denmark, Copenhagen, Denmark, Copenhagen NV, Denmark and 4 additional locations.
Who is sponsoring the NCT02869048 clinical trial?
NCT02869048 is sponsored by Rigshospitalet, Denmark. The principal investigator is Kirsten Møller, Prof., MD at Clinic of Neuroanestesiology, Rigshospitalet, Denmark. The trial plans to enroll 375 participants.
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