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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03403309
• Date of registration: 11/01/2018
• Prospective Registration: Yes
• Primary sponsor: Yonsei University
• Public title: 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
• Scientific title: 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 (IMPROVE MSA Study)
• Date of first enrolment: May 2, 2018
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03403309
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Intervention(s)

Drug: Placebo

Drug: 1) Inosine 5'-monophosphate

Primary Outcome(s)

Serum uric acid elevation [Time Frame: Baseline to Week 24]

Tolerability [Time Frame: Baseline to Week 24]

Safety [Time Frame: Baseline to Week 24]

Secondary Outcome(s)

Geriatric Depression Scale (GDS) [Time Frame: Baseline and Week 24, respectively]

Unified Multiple System Atrophy Rating Scale (UMSARS) [Time Frame: Baseline and Week 24, respectively]

Mini Mental Status Exam (MMSE) [Time Frame: Baseline and Week 24, respectively]

Montreal Cognitive Assessment (MoCA) [Time Frame: Baseline and Week 24, respectively]

Secondary ID(s)

4-2017-0990

Source(s) of Monetary Support

Please refer to primary and secondary sponsors