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Trial record 1 of 1 for:    EH301
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EH301 for the Treatment of ALS

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ClinicalTrials.gov Identifier: NCT03489200
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Fundación Universidad Católica de Valencia San Vicente Mártir
University of Valencia
Information provided by (Responsible Party):
Elysium Health

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: EH301 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: EH301 Other: EH301
1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene

Placebo Comparator: Placebo Other: Placebo
No intervention- placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. MRC [ Time Frame: 6 months ]
    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.

  2. FVC [ Time Frame: 6 months ]
    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.

  3. Electromyogram [ Time Frame: 6 months ]

    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.


  4. Anthropometry [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489200


Locations
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Spain
Universidad Católica de Valencia San Vicente Màrtir
Valencia, Spain
Sponsors and Collaborators
Elysium Health
Fundación Universidad Católica de Valencia San Vicente Mártir
University of Valencia

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Responsible Party: Elysium Health
ClinicalTrials.gov Identifier: NCT03489200     History of Changes
Other Study ID Numbers: H1479983999044
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases