Disease: ALS
Type of study: Interventional trial
Coordinating investigators: Tale L. Bjerknes & Ole-Bjørn Tysnes
Study director: Ole-Bjørn Tysnes
Background: Patients who have fulfilled the NO-ALS study will after the one-year randomisation period be invited to participate in the open label NO-ALS extension trial where all patients will receive active treatment. This is mainly a safety protocol to study long term safety of the treatment, but efficacy parameters will also be followed (ALSFRS-R and Vital capacity).
The primary objective of the NO-ALS extension study is to determine the long-term safety of treatment with oral NR and pterostilbene in ALS.
Design: NO-ALS extension is a multi-centre, phase II, open label clinical trial of NR/pterostilbene, in ALS. The study will continue until the NO-ALS trial is concluded.
Primary endpoint: The frequency of reported adverse events (AE) among all participants in the NO-ALS open label extension.
Status: By end of 2024, more than 100 patients are followed in the extension study.
Participating centres
- Haukeland University Hospital, Bergen
- Akershus University Hospital, Lørenskog
- Oslo University Hospital, Oslo
- Drammen Hospital, Vestre Viken
- St. Olav’s University Hospital, Trondheim
- Stavanger University Hospital, Stavanger
- University Hospital of North Norway, Tromsø
- Førde Central Hospital, Førde
- Haugesund Hospital, Haugesund
- Innlandet Hospital Trust, Lillehammer
- Nordland Hospital Trust, Bodø
- Namsos Hospital
- Molde Hospital
- Telemark Hospital Trust, Skien
- Østfold Hospital Trust, Kalnes
- Vestfold Hospital Trust, Tønsberg
- Sørlandet Hospital Trust, Kristiansand
Funding
- The Regional Health Authority of Western Norway (Helse Vest)
- KLINBEFORSK
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals