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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
EH301 (Nicotinamide Riboside/Pterostilbene)
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Individuals will be excluded if any of the following exclusion criteria apply:

  • Dementia, FTD or other neurodegenerative disorder interfereing 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

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Nordlandssykehuset HF
  • Vestre Viken HF
  • Helse Førde HF
  • Helse Fonna HF
  • Sørlandet sykehus
  • Sykehuset Innlandet HF
  • Akershus University Hospital
  • Helse Møre og Romsdal
  • Helse Nord-Trøndelag HF
  • Oslo Univerity Hospital
  • Sykehuset Østfold HF
  • Sykehuset i Telemark HF
  • Stavanger University Hospital
  • Universitetssykehuset Nord-Norge
  • St. Olavs Hospital HF
  • Sykehuset i Vestfold HF

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NO-ALS Extension Study High Dose EH301

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.

Secondary Outcome Measures

Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS. The minimum score is 0 and the maximum score is 48, the higher score the more function is retained.
Change in vital capacity
Vital capacity measured by spirometry.

Full Information

First Posted
October 4, 2021
Last Updated
September 22, 2023
Sponsor
Haukeland University Hospital
Collaborators
Elysium Health
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1. Study Identification

Unique Protocol Identification Number
NCT05095571
Brief Title
A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
Official Title
A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Elysium Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 per year. Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to NAD can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilben will stimulate sirtuins. The investigators want to study whether combination therapy with NR and Pterostilben 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 EH301 will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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 pasients completing 1 year follow up in the NO-ALS study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NO-ALS Extension Study High Dose EH301
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
EH301 (Nicotinamide Riboside/Pterostilbene)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.
Time Frame
Through study completion, 1 year
Secondary Outcome Measure Information:
Title
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
Description
ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS. The minimum score is 0 and the maximum score is 48, the higher score the more function is retained.
Time Frame
Determined after 12 months of follow-up.
Title
Change in vital capacity
Description
Vital capacity measured by spirometry.
Time Frame
Determined after 12 months of follow-up.
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Defined as how many are alive or not requiring continuous respiratory ventilation life support.
Time Frame
Determined after 12 months of follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Individuals will be excluded if any of the following exclusion criteria apply: Dementia, FTD or other neurodegenerative disorder interfereing 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ole-Bjørn Tysnes
Phone
+4755975063
Email
obty@haukeland.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Phone
+4755975063/+4790686700
Email
obty@haukeland.no
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Facility Name
Nordlandssykehuset HF
City
Bodø
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Espen Benjaminsen
Phone
+4748103893
Email
Espen.Benjaminsen@nordlandssykehuset.no
First Name & Middle Initial & Last Name & Degree
Espen Benjaminsen
Facility Name
Vestre Viken HF
City
Drammen
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kristine Bjørnå
Phone
+4741339297
Email
Ingrid.Kristine.Bjorna@vestreviken.no
First Name & Middle Initial & Last Name & Degree
Ingrid Kristine Bjørnå
Facility Name
Helse Førde HF
City
Førde
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Lif Breivik
Phone
+4793630457
Email
kristin.lif.breivik@helse-forde.no
First Name & Middle Initial & Last Name & Degree
Kristin Lif Breivik
Facility Name
Helse Fonna HF
City
Haugesund
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ineke HogenEsch
Phone
+4752732590
Email
ineke.hogenesch@helse-fonna.no
First Name & Middle Initial & Last Name & Degree
Ineke HogenEsch
Facility Name
Sørlandet sykehus
City
Kristiansand
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Unn Ljøstad
Phone
+4741208824
Email
unn.ljostad@sshf.no
First Name & Middle Initial & Last Name & Degree
Unn Ljøstad
Facility Name
Sykehuset Innlandet HF
City
Lillehammer
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grethe Kleveland
Phone
+4797157819
Email
Grethe.Kleveland@sykehuset-innlandet.no
First Name & Middle Initial & Last Name & Degree
Grethe Kleveland
Facility Name
Akershus University Hospital
City
Lørenskog
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Nakken
Phone
+4797659796
Email
ola.nakken@gmail.com
First Name & Middle Initial & Last Name & Degree
Ola Nakken
Facility Name
Helse Møre og Romsdal
City
Molde
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åse Morsund
Phone
+4747756360
Email
Ase.Hagen.Morsund@helse-mr.no
First Name & Middle Initial & Last Name & Degree
Åse Morsund
Facility Name
Helse Nord-Trøndelag HF
City
Namsos
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Devik
Phone
+4798833255
Email
Kristina.Devik@helse-nordtrondelag.no
First Name & Middle Initial & Last Name & Degree
Kristina Devik
Facility Name
Oslo Univerity Hospital
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
Phone
+4797674106
Email
angman@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
Facility Name
Sykehuset Østfold HF
City
Sarpsborg
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Hallerstig
Phone
+4798455652
Email
erika.carina.hallerstig@so-hf.no
First Name & Middle Initial & Last Name & Degree
Erika Hallerstig
Facility Name
Sykehuset i Telemark HF
City
Skien
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Berit Jøntvedt
Phone
+4747262912
Email
joan@sthf.no
First Name & Middle Initial & Last Name & Degree
Anne Berit Jøntvedt
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
Phone
+4745236149
Email
katrin.schluter@sus.no
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margitta Kampmann
First Name & Middle Initial & Last Name & Degree
Margitta Kampmann
Facility Name
St. Olavs Hospital HF
City
Trondheim
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene Ballo Kvernmo
Phone
+4791167718
Email
Helene.Ballo.Kvernmo@stolav.no
First Name & Middle Initial & Last Name & Degree
Helene Ballo Kvernmo
Facility Name
Sykehuset i Vestfold HF
City
Tønsberg
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolai Johan Brun
Phone
+4793243780
Email
nicolai.j.brun@siv.no
First Name & Middle Initial & Last Name & Degree
Nicolai Johan Brun

12. IPD Sharing Statement

Learn more about this trial

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

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