At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- ✓Neurologically stable with no relapse within 30 days before randomization
- ✓Capable of understanding and complying with the protocol
- ✕Primary progressive, secondary progressive, or progressive-relapsing MS
- ✕Prior use of Dimethyl Fumarate (DMF)
- ✕History of myocardial infarction, silent MI, or unstable angina
- ✕History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, or other major disease precluding participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
In Brief
A Phase 3 clinical trial evaluating ALKS 8700 and Dimethyl Fumarate for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 506 participants across 67 sites in 3 countries.
Detailed Summary
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
Study Details
Timeline
Interventions
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.