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A PHASE II, SINGLE-CENTER, RANDOMIZED DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF THE COMBINED THERAPY OF EH-301 AND N-ACETYLCYSTEINE TOGETHER WITH RILUZOLE IN AMBULANT PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)
EU CTIS ID: 2024-519857-13-00
What this study is testing
To evaluate the clinical efficacy and safety of the combination of NAC and EH301 compared to placebo on disease progression in ambulatory patients diagnosed with ALS via the ALS Functional Rating Scale-Revised (ALSFRS-R) score.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with ALS according to Gold Coast criteria.
- Duration of disease ≤ 18 months
- Males and females aged 18 to 75 years
- ALSFRS-R total score ≥ 30 for all 12 categories
- Forced vital capacity (FVC) ≥70%
- Participant must be treated with Riluzole (50 mg twice daily) for ≥30 days prior to Day 1 (Visit 2) and is expected to remain on that dose until the final study visit.
You likely can't join if
- Presence of other neurodegenerative diseases.
- Genetically confirmed mitochondrial disease
- Tracheostomized and/or gastrostomized patients
- Participation in any clinical trial with investigational product in the within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
- Any clinically significant laboratory abnormalities that may directly affect compliance or safety
- Allergy to NAC or any excipient of either the investigational drug or the nutraceutical EH301
See the full eligibility criteria
- Patients diagnosed with ALS according to Gold Coast criteria.
- Duration of disease ≤ 18 months
- Males and females aged 18 to 75 years
- ALSFRS-R total score ≥ 30 for all 12 categories
- Forced vital capacity (FVC) ≥70%
- Participant must be treated with Riluzole (50 mg twice daily) for ≥30 days prior to Day 1 (Visit 2) and is expected to remain on that dose until the final study visit.
- Willingness and ability of the patient to comply with protocol requirements during the study
- Sign written informed consent prior to any study-related procedures
- Acceptance by the women of the use of contraceptive measures 30 days prior to taking the nutraceutical and investigational drug and throughout the study. Acceptable contraceptive method means: non-hormonal intrauterine device (IUD), barrier method (condom), bilateral tubal occlusion, vasectomized partner (provided the partner has been provided with a medical evaluation of the success of the surgery), or abstinence from sexual intercourse, in women of childbearing age (e.g., women who are not postmenopausal or have not been surgically sterilized).
- Presence of other neurodegenerative diseases.
- Genetically confirmed mitochondrial disease
- Tracheostomized and/or gastrostomized patients
- Participation in any clinical trial with investigational product in the within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
- Any clinically significant laboratory abnormalities that may directly affect compliance or safety
- Allergy to NAC or any excipient of either the investigational drug or the nutraceutical EH301
- Patients with short life expectancy as judged by the investigator
- [Females only] Pregnancy or lactation for women of childbearing age (i.e., <2 years postmenopausal or not surgically sterile)
- Patient is unwilling to use highly effective contraceptive methods during.
- Significant cognitive impairment and/or dementia
- Any psychiatric illness that could interfere with the study
- Use of dietary supplements with high doses of vitamin B3 in the 30 days prior to inclusion in the study
- Severe cardiac disease
- Moderate to severe pulmonary disease, such as emphysema, stage III-IV COPD
- Chronic uncontrolled asthma
- Active cancer
- Any metabolic, neoplastic, physically or mentally debilitating disease that could put the subject at risk or may interfere with the results of the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.