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S48168 for Myopathy

Phase 1
Waitlist Available
Led By Payam Mohassel, M.D.
Research Sponsored by Armgo Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study Summary

This trial will test the safety and tolerability of S48168 (ARM210) in patients with RyR1-RM, as well as its effects on muscle function and fatigue.

Eligible Conditions
  • RYR-1 Myopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Adverse Events When Treated With S48168 (ARM210)

Side effects data

From 2023 Phase 1 trial • 7 Patients • NCT04141670
33%
Diarrhoea
33%
Dyspepsia
33%
Eosinophilia
33%
Gastrooesophageal reflux disease
33%
Skin laceration
33%
Blood creatine phosphokinase increased
33%
Hyperglycaemia
33%
Hyperkalaemia
33%
Arthralgia
33%
Myalgia
33%
Sinus headache
33%
Haematuria
33%
Pruritus
33%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Group
High Dose Group

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low dose groupExperimental Treatment1 Intervention
Experimental: 120 mg S48168 (ARM210; 6 x 20 mg tablets) daily for 29 days
Group II: High dose groupExperimental Treatment1 Intervention
Experimental: 200 mg S48168 (ARM210; 10 x 20 mg tablets) daily for 28 days (1 participant) or 29 days (3 participants)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S48168
2020
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Armgo Pharma, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,354 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,554 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
S 48168 (ARM 210) for the Treatment of RYR1-related Myopathies (RYR1-RM)
2020. "S 48168 (ARM 210) for the Treatment of RYR1-related Myopathies (RYR1-RM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04141670.
~2 spots leftby Apr 2025
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