Number of Participants With Adverse Events
| Group | Value (participants) |
|---|---|
| Inosine | 11 |
| Placebo | 7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name SURE-ALS2
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multi-center, 20-week study of inosine treatment. Study Objectives and Endpoints The primary objective of the study is to determine the safety and tolerability of oral administration of inosine (administered daily) dosed to moderately elevate serum urate over 20 weeks. The primary outcome measures will be 1. Safety, as measured by adverse events 2. Tolerability, defined as the ability of subjects to complete the entire 20-week study. As an exploratory objective, we will test the feasibility and utility of a smartphone application for monitoring symptoms and disease progression in patients with amyotrophic lateral sclerosis (ALS).
Experimental
Inosine
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo comparator
Placebo
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Outcomes the sponsor listed as primary.
Number of Participants With Adverse Events
Time frame · Baseline to Week 24
Safety will be assessed by the occurrence of adverse events such as kidney stones and gout (expected adverse events) in all participants receiving at least 1 dose of study drug
Tolerability to Complete the Entire 20 Week Study on Study Drug
Time frame · Baseline to Week 20
Tolerance of study drug will be defined as the number of participants who able to complete the 20-week study without permanently discontinuing study drug or suspending study drug for greater than 28 days
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Inosine | 11 |
| Placebo | 7 |
| Group | Value (Participants) |
|---|---|
| Inosine | 12 |
| Placebo | 7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| InosineSubjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL. Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL. | 0 / 14 | 4 / 14 | 11 / 14 |
| PlaceboSubjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL. Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL. | 1 / 9 | 1 / 9 | 7 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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