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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 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.

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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.

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

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03093324

The ClinicalTrials.gov registry entry for NCT03093324 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (178% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.