Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03093324 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
Phase 3
Development phase
506
Enrollment target
20
Study locations

NCT03093324: Completed Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Biogen.

NCT03093324 is a Phase 3 study of Relapsing Remitting Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 506 participants, above the 182-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03093324, a Phase 3 study of Relapsing Remitting Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 3
Development phase
506 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.

Conditions Studied

Relapsing Remitting Multiple Sclerosis

Interventions

  • DRUG Dimethyl Fumarate
  • DRUG ALKS 8700

Study Locations (20)

Florida

  • Alkermes Investigational Site - Atlantis
  • Alkermes Investigational Site - Bradenton
  • Alkermes Investigational Site - Maitland
  • Alkermes Investigational Site - Naples
  • Alkermes Investigational Site - Ormond Beach
  • Alkermes Investigational Site - Sarasota
  • Alkermes Investigational Site - Tampa
  • Alkermes Investigational Site - Vero Beach

Colorado

  • Alkermes Investigational Site - Basalt
  • Alkermes Investigational Site - Centennial
  • Alkermes Investigational Site - Denver

Arizona

  • Alkermes Investigational Site - Phoenix
  • Alkermes Investigational Site - Tucson

California

  • Alkermes Investigational Site - Long Beach
  • Alkermes Investigational Site - San Diego

Connecticut

  • Alkermes Investigational Site - Middlebury
  • Alkermes Investigational Site - Stamford

Alabama

  • Alkermes Investigational Site - Cullman

District of Columbia

  • Alkermes Investigational Site - Washington D.C.

Georgia

  • Alkermes Investigational Site - Atlanta

Trial Details

FieldValue
Enrollment Target 506 participants
Start Date 2017-03-15
Est. Completion 2019-06-27
Phase Phase 3
Biogen

334 total trials

What the finished NCT03093324 record still lists

NCT03093324 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, above the 182-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (178% higher).

The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Dimethyl Fumarate is the first listed.

NCT03093324 names 20 study sites across 8 states, led by Florida, Colorado, Arizona.

Frequently Asked Questions

What is clinical trial NCT03093324 about?

NCT03093324 is a clinical study titled "A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2". 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 Dimethy...

What is the current status of trial NCT03093324?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2017-03-15. Estimated completion is 2019-06-27.

What conditions does trial NCT03093324 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT03093324?

The interventions under investigation include: Dimethyl Fumarate (DRUG), ALKS 8700 (DRUG).

Who is sponsoring clinical trial NCT03093324?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03093324 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Relapsing Remitting Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03093324's enrollment target sits among peer trials

506 3rd of 25 higher than 23 of 25 other Relapsing Remitting Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Relapsing Remitting Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05069428 · 506 participants · Phase 4

    Delirium Reduction With Ramelteon

  • NCT05797168 · 506 participants · Phase 1

    Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

  • NCT06164717 · 507 participants · NA

    Behavioral and Neural Characteristics of Adaptive Speech Motor Control

  • NCT02115295 · 508 participants · Phase 2

    Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT03093324, the US trial registry maintained by the National Library of Medicine. NCT03093324 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.