Clinical study on the efficacy and tolerabilty of Guabenz in Amiotropic Lateral Sclerosis

Phase 1

• Conditions: Amiotrophic Lateral Sclerosis; MedDRA version: 19.1Level: PTClassification code 10028003Term: Motor neurone diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005367-32-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-17
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1) Diagnosis of, probable, probable laboratory supported or definite sporadic (SALS) or familiar (FALS) ALS according to the revised El Escorial criteria; 2) age >18 yrs; 3) onset =18 months before randomization; 4) sVC =70% in spinal onset; 5) riluzole 100 mg/day or no riluzole; 6) written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

1) PEG, NIV or tracheotomy; 3) known heart, renal or liver failure; 3) known intolerance to alfa2agonists; 4) known conditions at risk for cardiovascular disorders or symptomatic hypotension; 5) participation in a clinical trial within 3 months prior to the screening; 6) cognitive impairment defined by the Edinburg Cognitive and Behavior ALS Screen (ECAS) scale

Study & Design

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