Amyotrophic Lateral Sclerosis MedDRA version: 21.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Dutasterida
Product Name: Dutasterida
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: DUTASTERIDE
CAS Number: 164656-23-9
Other descriptive name: DUTASTERIDE
Concentration unit: mg
Sponsors
Facultad de medicina y ciencias de la salud de la Universidad Católica de Valencia
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the functional improvement of the combined treatment with Liposomal Turmeric / Resveratrol® with Dutasteride in comparison with patients in routine clinical practice;Secondary Objective: •Assess activity at the cognitive and behavioral level in ALS patients, and its effects on the quantity and quality of sleep, after the intervention with the combination of Liposomal Turmeric / Resveratrol® with Dutasteride, at baseline visit, 3 and 6 months. •Quantify the decrease in oxidative stress, after the intervention with the indicated drug combination, at the baseline visit, 3 and 6 months. •Quantify the possible decrease in inflammation, after the intervention with the indicated drug combination, at a baseline visit, 3 and 6 months. •Assess the effects on the intestinal microbiota, after the intervention with the indicated drug combination, related to cognitive and behavioral changes at the beginning, 3 and 6 months. •Assessment of muscle strength and capacity at baseline visit, 3 and 6 months after onset. •Assessment of the quantity and quality of sleep, after the intervention with the indicated combination of medications, at a baseline visit, 3 and 6 months.;Primary end point(s): Determine functional improvement, understanding as such a statistically significant increase in the mean score obtained on the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRR-R) associated with ALS with respect to the baseline visit, at 3 and 6 months. treatment.;Timepoint(s) of evaluation of this end point: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Motor Variables: The scales and tests carried out will try to determine improvement in muscular and respiratory activity, which deteriorates due to motor neuron damage. The tests will be the following: • Electromyography (EMG). Graphic recording technique of the electrical activity produced by skeletal muscles. EMG can be monitored through electrodes inserted into the muscles (intramuscular electrodes) or through electrodes on the surface of the skin over the muscle (superficial electrodes) with the FREE-EMG 300 Electromyograph (8 CHANNELS). This EMG is electromyographic data acquisition and analysis software. In this version, 8 acquisition channels are considered that allow the acquisition of EMG, Switch and / or Force Cell data. The graphical interface is designed for a 1280 x 1024 screen area. • TEST MRC 11 –steps-mrc grading scale measures muscle strength • Measurement of forced vital capacity (FVC): FVC is an indicator of lung capacity and would be obtained by performing spirometry, measuring it using a peak expiratory flow meter. - Variables for cognitive and behavioral assessment: The assessment of cognitive and behavioral functions will try to determine possible improvements in these functions, linked to the damage that occurs in the frontotemporal area of ??the cortex in patients with ALS. To carry out these assessments, the following cognitive and behavioral tests will be applied. The tests will be: • Edinburgh ELA Cognitive and Behavioral Exam (ECCE) • A behavioral test-interview with the caregiver that asks questions with a dichotomous answer Y / N about the presence of uninhibited behavior, apathy or behavioral inertia, lack of sympathy or empathy, perseverative, stereotyped, compulsive or ritualistic behavior, as well as hyperorality and alteration of eating behavior. Likewise, it collects 3 questions about the possible presence of psychotic symptoms. -Variables related to the microbiota: A Clinical Intestinal Microbiome will | — |
Countries
Spain
Contacts
Public ContactCarlos Barrios
FACULTAD DE MEDICINA Y CIENCIAS DE LA SALUD DE LA UNIVERSIDAD CATÓLICA DE VALENCIA
Outcome results
None listed