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Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients

NCT04654689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-10-08

No results posted yet for this study

Summary

Amyotrophic lateral sclerosis (ALS) is a disease of an inflammatory nature, which causes progressive muscle weakness associated with cognitive and behavioural disorders. Pathogenically, it is characterised by loss of oxidative control, excitotoxicity due to excess glutamate and intestinal dysbiosis. In the absence of curative treatment, the aim of the study is to assess the impact at a clinical level of the combination of liposomed polyphenols to improve their effectiveness, with the drug G04CB02 which shows great anti-ALS properties by Molecular Topology methodology. A prospective, longitudinal, mixed, analytical, experimental and double-blind study is proposed, with a population sample of 60 patients distributed randomly in 30 patients in the intervention group who will receive treatment for 2 months, and 30 patients in the control group who will receive a placebo for the same period. The assessment will be at time 0, and at 2 months and 4 months after treatment, with functional, cognitive and behavioural tests, and of the state of inflammation and oxidation; and at time 0 and 2 months, of the intestinal microbiota.

Conditions

Interventions

DIETARY_SUPPLEMENT

Liposomed polyphenols resveratrol and curcumin

Combination of resveratrol (75mg) and curcumin (200mg) liposomed

OTHER

Placebo for liposomed resveratrol and curcumin

Water with sucrose replacing the liposomed polyphenols

DIETARY_SUPPLEMENT

Isocaloric Diet

40% carbohydrates, 40% lipids and 20% proteins

DRUG

G04CB02

G04CB02, in a single daily dose for 2 months

OTHER

Placebo microcrystalline methylcellulose

Placebo replacing G04CB02

Sponsors & Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir

    lead OTHER

Principal Investigators

  • José Enrique De la Rubia Ortí, Ph · Catholic University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-20
Primary Completion
2022-11-12
Completion
2023-02-04
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654689 on ClinicalTrials.gov