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

NCT02288091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-11-06

Study results available
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Summary

This is a single center, open label, 12-week study of inosine treatment. Inosine treatment leads to an increase in the levels of urate (uric acid) in the blood.

The primary objective of the study is to determine the tolerability of oral administration of inosine.

Secondary study objectives include the measurement of biomarkers of oxidative stress and damage in response to inosine treatment.

Conditions

Interventions

DRUG

Inosine

Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline.

Sponsors & Collaborators

  • The Salah Foundation

    collaborator OTHER

  • Sean M. Healey & AMG Center for ALS

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Sabrina Paganoni, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2016-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288091 on ClinicalTrials.gov