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)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519857-13-00

Acronym

NADALS-001-ALS -2021

Enrollment

Registered

2025-04-21

Start date

2025-11-25

Completion date

Unknown

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Brief summary

Changes in the ALSFRS-R scale., Time to progression of patients suffering a 20% reduction in the ALSFRS-R scale 3.

Detailed description

Muscle strength measured by manual dynamometry., Survival., Quality of life measured by the ALSAQ-40 scale., Respiratory function through the percentage of forced capacity (%FVC)., Time elapsed until gastrostomy., Combined assessment of function and survival (CAFS)., Nfl rate in CSF and changes in serum Nfl rate.

Interventions

DRUGACETYLCYSTEINE

DRUGLa composición cualitativa y cuantitativa de cada sobre de placebo es la siguiente: Bicarbonato sódico 563

DRUG75 mg Diluyente/generador de efervescencia Ph Eur Ácido cítrico 410

DRUG0 mg Diluyente/generador de efervescencia Ph Eur Maltodextrina 651

DRUG25 mg Diluyente Ph Eur Sílice coloidal anhidra 10

DRUG0 mg Fluidificante/desecante interno Ph Eur Manitol 769

DRUG0 mg Diluyente Ph Eur Sacarina sódica 24

DRUG0 mg Edulcorante Ph Eur Aroma de naranja 72

DRUG0 mg Saborizante Espec.. interna Masa nominal 2.500 mg El polvo efervescente se envasa en sobres de papel y aluminio con recubrimiento interno de polietileno.

DRUGRILUZOLE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Changes in the ALSFRS-R scale., Time to progression of patients suffering a 20% reduction in the ALSFRS-R scale 3.	—

Secondary

Measure	Time frame
Muscle strength measured by manual dynamometry., Survival., Quality of life measured by the ALSAQ-40 scale., Respiratory function through the percentage of forced capacity (%FVC)., Time elapsed until gastrostomy., Combined assessment of function and survival (CAFS)., Nfl rate in CSF and changes in serum Nfl rate.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026