NCT03489200

Brief Summary

The objective of this trial is to evaluate the efficacy and tolerability of EH301 in patients with amyotrophic lateral sclerosis. Patients with ALS are randomized to receive either EH301 or placebo daily and undergo active evaluation for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

March 27, 2018

Last Update Submit

May 16, 2018

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • ALSFRS-r

    ALS Functional Rating Scale - revised score is a summation of ratings across across fine and gross motor, bulbar and respiratory functional domains. The scale ranges from 0-48, with higher total score representing better outcomes. The twelve subscales are rated on a five-point scale from 0 (can't do) to 4 (normal ability) and combined to compute the total score. This outcome measures change observed from baseline to 6 months.

    6 months

Secondary Outcomes (4)

  • MRC

    6 months

  • FVC

    6 months

  • Electromyogram

    6 months

  • Anthropometry

    6 months

Study Arms (2)

EH301

EXPERIMENTAL
Other: EH301

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

EH301OTHER

1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene

EH301
PlaceboOTHER

No intervention- placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Diagnosis of probable or definite (sporadic or familial) ALS by El Escorial criteria
  • Onset of symptomatology for more than 6 months
  • If female: not lactating; negative pregnancy test; agree to use an effective method of birth control throughout study

You may not qualify if:

  • Tracheostomy, invasive ventilation, or non-invasive positive pressure ventilation
  • Gastrostomy
  • Evidence of major psychiatric disorder or clinically evident dementia
  • Diagnosis of a neurodegenerative disease in addition to ALS
  • Current medication apart from riluzole that in the opinion of the investigator would make the patient unsuitable for study participation
  • Recent history (within the previous 6 months) or current evidence of alcohol or drug abuse
  • Concurrent unstable disease involving any system (e.g. carcinoma other than basal cell carcinoma), any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of coronary artery disease, or any other condition that in the opinion of the investigator would make the patient unsuitable for study participation
  • Baseline QTc (Bazett) \> 450 msec for males and \> 470 msec for females
  • Known hepatitis B/C or HIV positive serology
  • Renal impairment defined as blood creatinine \> 2x ULN
  • Hepatic impairment and/or liver enzymes (ALT or AST) \> 3x ULN
  • Hemostasis disorders or current treatment with oral anticoagulants
  • Participated in any other investigational drug or therapy study with a non-approved medication, within the previous 3 months
  • No medical insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Valencia San Vicente Màrtir

Valencia, Spain

Location

Related Publications (1)

  • Carrera-Julia S, Estrela JM, Zacares M, Navarro MA, Vega-Bello MJ, de la Rubia Orti JE, Moreno ML, Drehmer E. Effect of the Mediterranean diet supplemented with nicotinamide riboside and pterostilbene and/or coconut oil on anthropometric variables in amyotrophic lateral sclerosis. A pilot study. Front Nutr. 2023 Sep 22;10:1232184. doi: 10.3389/fnut.2023.1232184. eCollection 2023.

    PMID: 37810917DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 5, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)