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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)

Short name SURE-ALS2

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the conditions.

Overview

Status
Completed
Phase
Phase 2
Enrollment
48 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Oct 2017
Primary completion
10 Dec 2019
Completion
7 Jan 2020
First posted
30 May 2017
Last update posted
18 Feb 2021
Conditions
Amyotrophic Lateral Sclerosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 2

    SURE-ALS2

    NCT03168711

    1 Oct 2017 to 7 Jan 2020

Registry summary

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).

Interventions

  • InosineDrug
  • PlaceboDrug

Arms2

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events

    Time frame · Baseline to Week 24

    Registry description

    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

  2. Tolerability to Complete the Entire 20 Week Study on Study Drug

    Time frame · Baseline to Week 20

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to Week 24

Number of Participants With Adverse Events

GroupValue (participants)
Inosine11
Placebo7
Primary outcomeCount of participants· Baseline to Week 20

Tolerability to Complete the Entire 20 Week Study on Study Drug

GroupValue (Participants)
Inosine12
Placebo7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 144 / 1411 / 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 / 91 / 97 / 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

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBeukenhorst AL, Burke KM, Scheier Z, Miller TM, Paganoni S, Keegan M, Collins E, Connaghan KP, Tay A, Chan J, Berry JD, Onnela JP. Using Smartphones to Reduce Research Burden in a Neurodegenerative Population and Assessing Participant Adherence: A Randomized Clinical Trial and Two Observational Studies. JMIR Mhealth Uhealth. 2022 Feb 4;10(2):e31877. doi: 10.2196/31877. PMID 35119373

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Age 18-85. 2. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria (Appendix 1). 3. Slow vital capacity (SVC) ≥ 60% of predicted for age, height, and gender at the Screening Visit. 4. Capable of providing informed consent and following trial procedures. 5. Serum urate \< 5.5 mg/dL at screening (i.e. below the population median serum urate levels). 6. Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method. 7. Is able and willing to participate in the Mobile app study procedures. Exclusion Criteria: 1. History of urolithiasis. 2. Urine pH \< 5.5 at screening (as acidic urine is a major determinant of uric acid urolithiasis). 3. History of gout. 4. History of stroke or myocardial infarction. 5. History of symptomatic coronary artery disease (e.g. angina pectoris) or symptomatic peripheral arterial disease within 1 year prior to Screening. 6. Symptomatic congestive heart failure with a documented ejection fraction below 45%. 7. Poorly controlled arterial hypertension (SBP\>160mmHg or DBP\>100mmHg at Screening). 8. Women who are pregnant or lactating. 9. The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to Site Investigator judgment, or a history of active substance abuse within the prior year. 10. Anything that, in the opinion of the Site Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study. 11. Use of the following within 30 days prior to Screening: inosine, allopurinol, probenecid, more than 300mg vitamin C daily (note that a subject may take a standard multivitamin up to one tablet or capsule daily). Use of thiazides is permissible as long as the subject is on a stable dose from 1 week prior to Screening. 12. Known hypersensitivity or intolerability to inosine. 13. Renal insufficiency as defined by eGFR \< 60 mL/min/1.73m2 at the time of screening.

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