Disease: ALS
Type of study: Interventional trial
Coordinating investigators: Tale L. Bjerknes & Ole-Bjørn Tysnes
Study directors: Ole-Bjørn Tysnes & Charalampos Tzoulis
Background: There are currently no neuroprotective treatments for ALS with a significant impact on disease progression. Previous research by the PD Node and others has nominated NAD-replenishment therapy as a promising neuroprotective strategy against neurodegeneration. Moreover, a recently published small trial using a combination of the NAD-precursor nicotinamide riboside (NR) and sirtuin booster pterostilbene, showed encouraging findings in ALS. To test the potential of this strategy as a neuroprotective therapy for ALS, we are running the NO-ALS trial.
The primary objective of the NO-ALS study is to determine whether a high dose of oral NR/pterostilbene delays disease progression in ALS measured by the revised ALS-FRS (ALS functioning rating scale).
Design: NO-ALS is a multicentre, phase II randomised double-blinded clinical trial, comparing combined oral NR and pterostilbene to placebo in early ALS. A total of 180 patients will be nation-wide recruited to study arm 1.
Primary endpoint: Between-group difference in the change in total ALS-FRS score between baseline and end of study.
Status: Patients have been included since October 2020. By the end of 2024, a total of 277 patients have been included, 143 in study arm 1 which requires 180 included patients. The study is expected to close inclusion by the end of 2024. Four new NO-ALS centres have joined since 2022 (Bodø, Lillehammer, Molde and Kristiansand).
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
- Nordland Hospital Trust, Bodø
- Innlandet Hospital Trust, Lillehammer
- Molde Hospital
- 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