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Completed

NCT Number: NCT03489200

EH301 for the Treatment of ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica de Valencia San Vicente Màrtir

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EH301

Other

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

Placebo

Other

No intervention- placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Elysium Health

Industry

Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir
  • University of Valencia

Registry information

Official study title

EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2018
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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