A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The mean survival from the time of diagnosis is 2.5 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK (Norwegian kroner) per year.

Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to Nicotinamide Adenine Dinucleotide (NAD) can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilbene will stimulate sirtuins.

The investigators want to study whether combination therapy with NR and Pterostilbene can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS.

In the NO-ALS extension study the investigators will follow the patients who completed the original NO-ALS study. Objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of NR and pterostilbene (EH301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.

NCT04562831

Amyotrophic Lateral Sclerosis

ACTIVE_NOT_RECRUITING NA

A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

NCT00694941

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE2

A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

NCT01281631

Amyotrophic Lateral Sclerosis

COMPLETED PHASE2

Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00403104

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE2

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)

NCT05039099

Amyotrophic Lateral Sclerosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is a multicenter open label study as a follow up of the NO-ALS trial. Newly diagnosed ALS cases were included in the study arm 1. Earlier ALS cases were included in study arm 2 to allow patients with earlier ALS to participate in the study as the treatment options outside the study were limited. The NO-ALS study will be stopped when we reach 180 patients in the group with newly diagnosed ALS cases (arm 1). This is the follow up study for patients completing 1 year follow up in the NO-ALS study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NO-ALS Extension Study High Dose EH301

Group Type OTHER

EH301 (Nicotinamide Riboside/Pterostilbene)

Intervention Type DIETARY_SUPPLEMENT

For this study EH301 is defined as Investigational Product(s) (IP). The ALS extension study is an open label study with active treatment of all patients thet have passed through the NO-ALS trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EH301 (Nicotinamide Riboside/Pterostilbene)

For this study EH301 is defined as Investigational Product(s) (IP). The ALS extension study is an open label study with active treatment of all patients thet have passed through the NO-ALS trial.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who fulfilled the criteria for the NO-ALS study and have completed the study will be proposed inclusion in the NO-ALS extension study protocol. Patients from both arm 1 and arm 2 in the NO-ALS study will be allowed inclusion in the prolongation study

Exclusion Criteria

* Dementia, fronto temporal dementia (FTD) or other neurodegenerative disorder interfering with compliance.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder.
* 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.
* Use of Vit B3 or blue berry extracts outside the study

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ole-Bjørn Tysnes

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING