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COMPLETED Phase 3

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

NCT03093324 · View on ClinicalTrials.gov ↗

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.

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

74 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03093324 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03093324?

The interventions under investigation include: Dimethyl Fumarate (DRUG), ALKS 8700 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03093324?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial