A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

Completed · Phase 3

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03093324

Run by

Biogen

People needed

506

Starts

2017-03-15

Expected to finish

2019-06-27

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Alkermes Investigational Site — Phoenix, Arizona, United States
• Alkermes Investigational Site — Tucson, Arizona, United States
• Alkermes Investigational Site — Long Beach, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Basalt, Colorado, United States
• Alkermes Investigational Site — Centennial, Colorado, United States
• Alkermes Investigational Site — Denver, Colorado, United States
• Alkermes Investigational Site — Middlebury, Connecticut, United States
• Alkermes Investigational Site — Stamford, Connecticut, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Atlantis, Florida, United States
• Alkermes Investigational Site — Bradenton, Florida, United States
• Alkermes Investigational Site — Maitland, Florida, United States
• Alkermes Investigational Site — Naples, Florida, United States
• Alkermes Investigational Site — Ormond Beach, Florida, United States
• Alkermes Investigational Site — Sarasota, Florida, United States
• Alkermes Investigational Site — Tampa, Florida, United States
• Alkermes Investigational Site — Vero Beach, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Columbus, Georgia, United States
• Alkermes Investigational Site — Evanston, Illinois, United States
• Alkermes Investigational Site — Des Moines, Iowa, United States
• Alkermes Investigational Site — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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