Status:
COMPLETED
The Effect of RNS60 on ALS Biomarkers
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
ALS Association
Get Out Onlus
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatment...
Detailed Description
ALS is a rare neurodegenerative disease that affects motor neurons in the spinal cord, brainstem and motor cortex. The only drug showing to improve survival in patients with ALS is riluzole. However, ...
Eligibility Criteria
Inclusion
- Age 18 through 80 years inclusive;
- Geographically accessible to the site and able to come to the site once a week for 24 weeks;
- Definite, probable, probable laboratory supported ALS diagnosis according to the revised El Escorial criteria; 4) Disease duration 6 to 24 months from symptom onset;
- 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; 8) Ability to understand and comply with the study requirements and to give written informed consent personally or via a legally authorized representative; 9) Treatment with riluzole 50 mg twice/day for at least 1 month prior to screening visit.
- Self sufficiency: this term reflect independence in daily living activities. It is an intuitive parameter to indicate preservation of key functional activities, and - not least - it has shown to be a valid and reliable measure
Exclusion
- History of HIV, clinically significant chronic hepatitis, antecedent polio infection, or other active infection;
- Motor neuron disease (MND) other than ALS;
- Involvement of systems other than motor possibly determining a functional impairment (as measured by the end-points) for the entire duration of the study;
- Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with impact on survival or functional disability in the next 12 months;
- Renal insufficiency as defined by a serum creatinine \> 1.5 times the upper limit of normal;
- Poor compliance with previous treatments;
- Other experimental treatments in the preceding 3 months;
- Women who are lactating or able to become pregnant (e.g. who are not post menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and 3 months after its completion;
- Unwillingness or inability to take riluzole; 10) Poor capability to use an inhalation device;
- Abnormal liver function defined as AST and/or ALT \> 3 times the upper limit of the normal.
Key Trial Info
Start Date :
May 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03456882
Start Date
May 30 2017
End Date
May 30 2021
Last Update
April 21 2023
Active Locations (23)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Azienda Opsedaliera Universitaria Consorziale Policlinico- Università degli studi di Bari
Bari, Italy
3
Spedali civili di Brescia
Brescia, Italy
4
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, Italy