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NCT07414212RECRUITINGanonymous

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)

Sponsor

Source record

Biogipuzkoa Health Research Institute

Phase

Source record

PHASE1

Modality

AI-normalized

small molecule

Target

AI-normalized

Acetylcysteine, EH301, Riluzole

Indication / condition

AI-normalized

Amyotrophic Lateral Sclerosis

Intervention

Source record

Acetylcysteine, EH301, Riluzole

Source & freshness

Source record

NCT ID

NCT07414212

Original source

ClinicalTrials.gov

Source last updated

Feb 17, 2026

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT07414212

Title

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)

Sponsor

Biogipuzkoa Health Research Institute

Status

RECRUITING

Phase

PHASE1

Condition raw

Amyotrophic Lateral Sclerosis

Condition normalized

Amyotrophic Lateral Sclerosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Acetylcysteine, EH301, Riluzole

Target normalized

Acetylcysteine, EH301, Riluzole

Interventions

Acetylcysteine, EH301, Riluzole

Public preview

Source record

This study is designed to evaluate whether a combination of N-acetylcysteine (NAC) and EH-301 can slow down or improve symptoms of amyotrophic lateral sclerosis (ALS). Researchers will assess changes in disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R), a standard tool for measuring daily functioning in people with ALS.

The main question is whether taking NAC together with EH-301 can prevent symptom worsening and possibly improve existing ALS symptoms.

Participants will be randomly assigned to receive either the active combination (NAC + EH-301) or matching placebos for 6 months. During this period, they will attend regular clinic visits for evaluations, tests, and safety monitoring.

After completing the initial 6-month phase, all participants may choose to join a 6-month open-label extension, where everyone receives the active treatment regardless of their original group.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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