Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
EH301, Placebo
Placebo:
Yes
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Elysium Health
Estimated Enrollment:
32
Estimated Study Start Date:
01 / 01 / 2017
Estimated Study Completion Date:
06 / 01 / 2017
Posting Last Modified Date:
05 / 18 / 2018
Date Study Added to neals.org:
04 / 05 / 2018
Minimum Age:
18 Years
Maximum Age:
N/A
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
Universidad Católica de Valencia San Vicente Màrtir
Valencia
Spain