EH301 for the Treatment of ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03489200
• Date of registration: 27/03/2018
• Prospective Registration: No
• Primary sponsor: Elysium Health
• Public title: EH301 for the Treatment of ALS
• Scientific title: EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
• Date of first enrolment: January 2017
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03489200
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Other: Placebo

Other: EH301

Primary Outcome(s)

ALSFRS-r [Time Frame: 6 months]

Secondary Outcome(s)

Anthropometry [Time Frame: 6 months]

MRC [Time Frame: 6 months]

FVC [Time Frame: 6 months]

Electromyogram [Time Frame: 6 months]

Secondary ID(s)

H1479983999044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundación Universidad Católica de Valencia San Vicente Mártir

University of Valencia