The effects of RNS60 on ALS biomarkers

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis; MedDRA version: 21.1Level: LLTClassification code 10052889Term: ALSSystem Organ Class: 10029205 - Nervous system disorders; 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: EUCTR2016-002382-62-IT
• Lead Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-22
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1)Age 18 through 70 years inclusive;
2)Geographically accessible to the site and able to come to the site center once a week for 24
weeks;
3)Definite or probable ALS diagnosis according to the revised El Escorial criteria;
4)Disease duration 6 to 24 months from symptom onset to study entry;
5)Self sufficiency: Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking);
6)Satisfactory respiratory function (FVC =80% of predicted);
7)Documented progression of symptoms in the last three months as measured by the ALSFRS-R scale (decrease of at least one point);
8)Ability to understand and comply with the study requirements;
9)Ability to give written informed consent personally or, as an alternative, via a legally authorized representative;
10)Treatment with riluzole 50 mg twice/day for at least 1 month prior to screening visit.

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 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1)History of HIV, clinically significant chronic hepatitis, antecedent polio infection, or other active infection;
2)Motor neuron disease (MND) other than ALS;
3)Involvement of other systems possibly determining a functional impairment (as measured by the end-points) for the entire duration of the study;
4)Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with impact on survival or functional disability in the next 12 months;
5)Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal
6)Poor compliance with previous treatments;
7)Other experimental treatments in the preceding 3 months;
8)Women who are lactating or able to become pregnant and men unable to practice contraception for the duration of the treatment and 3 months after its completion;
9)Unwillingness or inability to take riluzole;
10)Poor compliance with an inhalation device;
11)Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the normal.

Study & Design

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