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

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:

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.

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Vestre Viken HFRecruiting
  • Helse Førde HFRecruiting
  • Helse Fonna HFRecruiting
  • Akershus University HospitalRecruiting
  • Oslo University HospitalRecruiting
  • Stavanger University HospitalRecruiting
  • Universitetssykehuset Nord-NorgeRecruiting
  • St.Olavs Hospital HFRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Newly diagnosed ALS patients

Earlier diagnosed ALS patients

Arm Description

High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene) Placebo

High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) Placebo

Outcomes

Primary 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.

Secondary Outcome Measures

Change in vital capacity
Vital capacity in sitting position and supine by spirometry. Spirometry measures the amount of air that can be inhaled or exhaled and vital capacity is the volume of air breathed out after the deepest inhalation, the higher value the better vital capacity.
Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS)
ECAS determines cognitive and behavioural changes of patients suffering from ALS. The minimum score is 0 and the maximum score is 136, the lower the score the greater the deficit.
Change of Neurofilament light chain (NFL) levels in serum
NFL levels in serum, baseline values and changes during the study.
Change in quality of life as assessed by the quality of life questionnaire SF-36
SF-36 is a 36-item patient-reported survey of patient health. The minimum score is 0 and the maximum score is 100. The higher the score the less disability.

Full Information

First Posted
September 10, 2020
Last Updated
September 22, 2023
Sponsor
Haukeland University Hospital
Collaborators
Elysium Health
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1. Study Identification

Unique Protocol Identification Number
NCT04562831
Brief Title
The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.
Official Title
A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (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 average survival from the time of diagnosis is 3 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 study, the investigators will use 2 different dosages on the active treatment and strength calculations show that 180 patients are needed to show a rather weak effect. Patients will be recruited in collaboration with hospitals in Helse Vest, AHUS, Drammen, OUS and St. Olavs hospital.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Newly diagnosed ALS patients
Arm Type
Experimental
Arm Description
High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene) Placebo
Arm Title
Earlier diagnosed ALS patients
Arm Type
Experimental
Arm Description
High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
EH301 (Nicotinamide Riboside/Pterostilbene)
Intervention Description
Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients.
Primary 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
Change from baseline to 1 year
Secondary Outcome Measure Information:
Title
Change in vital capacity
Description
Vital capacity in sitting position and supine by spirometry. Spirometry measures the amount of air that can be inhaled or exhaled and vital capacity is the volume of air breathed out after the deepest inhalation, the higher value the better vital capacity.
Time Frame
Change from baseline to 1 year
Title
Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS)
Description
ECAS determines cognitive and behavioural changes of patients suffering from ALS. The minimum score is 0 and the maximum score is 136, the lower the score the greater the deficit.
Time Frame
Change from baseline to 1 year
Title
Change of Neurofilament light chain (NFL) levels in serum
Description
NFL levels in serum, baseline values and changes during the study.
Time Frame
Change from baseline to 1 year
Title
Change in quality of life as assessed by the quality of life questionnaire SF-36
Description
SF-36 is a 36-item patient-reported survey of patient health. The minimum score is 0 and the maximum score is 100. The higher the score the less disability.
Time Frame
Change from baseline to 1 year
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Survival of patients through the study
Time Frame
Through study completion, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
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
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Facility Name
Vestre Viken HF
City
Drammen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kristine Bjørnå
First Name & Middle Initial & Last Name & Degree
Ingrid Kristine Bjørnå
Facility Name
Helse Førde HF
City
Førde
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Lif Breivik
First Name & Middle Initial & Last Name & Degree
Kristin Lif Breivik
Facility Name
Helse Fonna HF
City
Haugesund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ineke HogenEsch
First Name & Middle Initial & Last Name & Degree
Ineke HogenEsch
Facility Name
Akershus University Hospital
City
Lørenskog
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Nakken
First Name & Middle Initial & Last Name & Degree
Ola Nakken
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
Country
Norway
Individual Site Status
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrid Botne Sando
First Name & Middle Initial & Last Name & Degree
Sigrid Botne Sando

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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