COMPARISON OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE IMPROVEMENT OF PATIENTS WITH ELA WHO ARE BEING TREATED WITH RILUZOLE

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis; MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-001989-38-ES
• Lead Sponsor: Facultad de medicina y ciencias de la salud de la Universidad Católica de Valencia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Male patients over 18 years of age or female patients over 50 years of age who are not fertile, and between 18 and 50 years of age who have accepted the use of contraceptives if they are of childbearing age and renounce becoming pregnant during the intervention.
•Patients diagnosed and symptomatic of ALS for at least 6 months prior to inclusion in the study.
•Patients treated with Riluzole at least one month before inclusion in the study.
•Acceptance of participation in the study by signing the IC form.
•At the discretion of the investigator, the patient must be able to meet the requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Patients with tracheostomy.
•Patients with invasive or non-invasive ventilation with positive ventilatory pressure.
•Participation in any other trial or in the 4 weeks prior to inclusion.
•Gastro-stomized patients.
•We are ill with evidence of dementia.
•We are ill with dependence on alcohol or drug abuse.
•Patients infected with hepatitis B or C, or HIV positive.
•Kidney patients with creatinine 2 times higher than normal markers 30 days before inclusion.
9.Hepatic patients with hepatic markers (ALT, AST) elevated 3 times above normal levels 30 days prior to enrollment.
10.Patients treated with anticoagulants or with hemostatic problems 30 days before inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified