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A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron emission tomography (PET) imaging.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial , Biomarkers/Imaging

Study Status:

Not enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Sabrina Paganoni, MD, PhD (Massachusetts General Hospital)
Nazem Atassi, MD (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

NCT02525471

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital
Lindsay Pothier / .(JavaScript must be enabled to view this email address) / 617-643-5582
.(JavaScript must be enabled to view this email address) 165 Cambridge St.
Boston, Massachusetts 02114 United States

Full Study Summary:

Following screening visit to determine eligibility, enrolled subjects will undergo the baseline visit within 6 weeks where the first intravenous (IV) infusion of study medication, RNS60, will be administered. Study medication for inhalation use will be dispensed at this time, and again at weeks 7 and 15. Subjects will continue once a week follow ups to receive RNS60 by IV infusion, continuing inhalation use the remaining 6 days per week, for 24 weeks total. Additionally, eligible subjects will undergo PET imaging at baseline and again between weeks 18 and 23.
RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 24 weeks.

Study Sponsor:

MGH ALS Therapy Fund

Participant Duration:

24 weeks

Estimated Enrollment:

24

Estimated Study Start Date:

09/30/2015

Estimated Study Completion Date:

03/31/2018

Posting Last Modified Date:

08/25/2017

Date Study Added to alsconsortium.org:

08/23/2015
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    No contraindications to undergo MRI studies

  • Site Contact Information

    Massachusetts General Hospital
    Fernando Gonterman; Paul Cernasov / .(JavaScript must be enabled to view this email address) / 617-726-0563
    Neurological Clinical Research Institute
    Boston, Massachusetts 02114
    United States