Inosine 5'-Monophosphate to Raise of Serum Uric Acid Level in Patients With Multiple System Atrophy: a Multi-center, Randomized Controlled, Double Blind, Parallel Assigned Clinical Trial

• Status: Completed
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: All

Summary

A purpose of the present study is to investigate the capability of serum uric acid elevation, safety, and tolerability of inosine 5'-monophosphate in patients with multiple system atrophy with multicenter, randomized, placebo controlled, parallel assigned design. This may provide the cornerstone for future extended trial in multiple system atrophy, a debilitating disease to date.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Uric Acid

Criteria

Inclusion Criteria:

1. Subjects who met the clinical criteria of either probable or possible multiple system atrophy, age ranged from 19 to 75 at their onset of symptom.

2. Subjects who underwent brain magnetic resonance imaging or 18F-fluorodeoxyglucose positron emission tomography at the time of their diagnosis in which showed any findings compatible to multiple system atrophy, such as cerebellar or putaminal atrophy, putaminal hyperintense rim or iron accumulation, hot cross bun sign or T2 high signal intensities on middle cerebellar peduncle, and decreased glucose metabolism on putamen or cerebellum.

3. Total score of unified multiple system atrophy rating scale 30 or more at baseline screening.

4. Serum uric acid level ≤ 6.0 mg/dL at baseline screening.

Exclusion Criteria:

1. Prior history of gout, nephrolithiasis, stroke, or chronic kidney disease.

2. Presentation of urine pH ≤ 5.0 or uric acid crystalluria on urine analysis at baseline screening.

3. Subject who showed febrile condition or have any sort of unstable and hopeless disorders.

4. Subjects on following medications undergo 4 weeks of wash-out period, and then not co-administered at all over study duration: co-enzyme Q, creatine, daily vitamin E 50 IU or more, and daily vitamin C 300 mg or more.

5. Presence of psychiatric or cognitive impairment by which interrupt to carry out the whole process of the study.