Amyotrophic Lateral SclerosisNCT03489200
EH301 for the Treatment of ALS
A study testing EH301 in people with Amyotrophic Lateral Sclerosis, run by Elysium Health at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- EH301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- EH301, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EH301Other
1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene
PlaceboOther
No intervention- placebo
| Study group | Role | What they receive |
|---|---|---|
| EH301 | Experimental | Not described Receives: Other: EH301 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
MRC
Medical Research Council Scale measures the strength of muscles in ALS patients. This 11-step grading scale is a summation of scores for 8 different muscles, each with a subscale of 0 (no muscle contraction) to 5 (normal power). To calculate the total MRC Index a progressively increasing number from 0 (0 in the scale) to 10 (5 in the scale) is given to each step and each muscle. The total MRC index per patient corresponds to the sum of the numbers given to all 8 muscles. This outcome measures change observed in MRC Index from baseline to 6 months.
Measured: 6 months
FVC
Forced Vital Capacity is a predictor of survival and disease progression in ALS patients and is measured using a touch spirometer and expressed as the % of standard value depending on sex, weight, and age parameters. This outcome measures change observed from baseline to 6 months.
Measured: 6 months
Electromyogram
A surface electromyogram (EMG) measuring device is used to measure muscle activity in the same muscles as the MRC Index. Muscle activity is expressed as the EMG amplitude (uV).
This outcome measures change in EMG amplitude observed from baseline to 6 months.
Measured: 6 months
Anthropometry
Fat and skeletal muscle weights (kg) are calculated following standard anthropometric procedures. Fat and skeletal weight outcomes refer to change observed comparing baseline vs 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Universidad Católica de Valencia San Vicente Mártir, University of Valencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489200
- Sponsor's protocol ID
- H1479983999044
- Status last verified
- May 2018
- First submitted
- 27 Mar 2018
- Last updated
- 18 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37810917
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03489200
- Acronym / sponsor ID
- H1479983999044
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- Fundación Universidad Católica de Valencia San Vicente Mártir, University of Valencia
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EH301 | Experimental | Other: EH301 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EH3011-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene | Other | EH301 |
| PlaceboNo intervention- placebo | Other | Placebo |
Primary outcome
ALSFRS-r
Time frame: 6 months
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.
4 secondary outcomes
MRC
Time frame: 6 months
FVC
Time frame: 6 months
Electromyogram
Time frame: 6 months
Anthropometry
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Derived from this study: PubMed 37810917Carrera-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EH301 in people with Amyotrophic Lateral Sclerosis, run by Elysium Health at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALSFRS-r (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.