Nicotinamide and Pterostilbene for treating ALS

A Randomized Placebo-controlled Trial of Nicotinamide/pterostilbene Supplement in ALS: the NO-ALS Study

This study is testing if a new combination treatment with Nicotinamide and Pterostilbene can help people with ALS feel better and slow down the disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: Haukeland University Hospital (Academic / other)
• Locations: 9 sites (Bergen and 8 other locations)
• Trial ID: NCT04562831 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a combination therapy using Nicotinamide Riboside and Pterostilbene on patients with Amyotrophic Lateral Sclerosis (ALS). The aim is to determine if this treatment can inhibit neurodegeneration, delay disease progression, and improve the quality of life for ALS patients. The study will involve two groups of participants: newly diagnosed and those with a longer history of ALS, with a total of 180 patients needed to assess the treatment's efficacy. Participants will be monitored for changes in their condition while receiving the treatment alongside standard care with Riluzole.

Who should consider this trial

Good fit: Ideal candidates include adults aged 35 and older with a clinical diagnosis of probable ALS within the last two years who are currently being treated with Riluzole.

Not a fit: Patients with dementia, other neurodegenerative disorders, or psychiatric conditions that may affect compliance will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly delay the progression of ALS and enhance the quality of life for patients.

How similar studies have performed: While this approach is novel in the context of ALS, previous studies have shown promise in using similar mechanisms to target neurodegeneration.

Eligibility criteria

Inclusion Criteria:

Arm 1 (newly diagnosed ALS patients)

* Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
* MR of the brain and cervical spine cannot explain symptoms.
* Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2
* Symptom onset no longer than 2 year prior to inclusion.
* ALS-FRC-R of 36 or more (not any item below 2).
* Age equal to or greater than 35 years at time of enrollment

Arm 2 (earlier diagnosed ALS patients)

* Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
* MR of the brain and cervical spine cannot explain symptoms.
* Treated with Riluzole 50mg x 2.

Exclusion Criteria:

* Dementia, FTD or other neurodegenerative disorder at baseline visit
* Any psychiatric disorder that would interfere with compliance in the study.
* Use of high dose vitamin B3 supplementation within 30 days of enrollment
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Genetically confirmed mitochondrial disease
* Patients who become tracheostomized as part of the treatment of ALS
* Patients with short expected survival at the discretion of the investigator. Such cases cannot be expected to follow protocol procedures.

Where this trial is running

Bergen and 8 other locations

• Haukeland University Hospital — Bergen, Norway (Recruiting)
• Vestre Viken HF — Drammen, Norway (Recruiting)
• Helse Førde HF — Førde, Norway (Recruiting)
• Helse Fonna HF — Haugesund, Norway (Recruiting)
• Akershus University Hospital — Lørenskog, Norway (Recruiting)
• Oslo University Hospital — Oslo, Norway (Recruiting)
• Stavanger University Hospital — Stavanger, Norway (Recruiting)
• Universitetssykehuset Nord-Norge — Tromsø, Norway (Recruiting)
• St.Olavs Hospital HF — Trondheim, Norway (Recruiting)

Study contacts

• Principal investigator: Ole-Bjørn Tysnes — Haukeland University Hospital
• Study coordinator: Ole-Bjørn Tysnes

Conditions Amyotrophic Lateral Sclerosis