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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03168711 |
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Date of registration:
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24/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)
SURE-ALS2 |
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Scientific title:
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Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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October 1, 2017 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03168711 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Sabrina Paganoni, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Inosine
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Drug: Placebo
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Primary Outcome(s)
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Safety Will be Assessed by the Occurrence of Adverse Events
[Time Frame: Baseline to Week 24]
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Tolerability to Complete the Entire 20 Week Study on Study Drug
[Time Frame: Baseline to Week 20]
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Secondary ID(s)
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SURE-ALS2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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