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

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ClinicalTrials.gov Identifier: NCT03093324
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will assess the gastrointestinal (GI) tolerability of ALKS 8700 in adult subjects with RRMS

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: ALKS 8700 Drug: Dimethyl Fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 8700
Capsules, administered orally
Drug: ALKS 8700
Oral capsules, administered twice daily

Active Comparator: Dimethyl Fumarate
Capsules, administered orally
Drug: Dimethyl Fumarate
Oral capsules, administered twice daily
Other Name: Tecfidera




Primary Outcome Measures :
  1. Number of days with GI events using an individual GI symptom scale [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Number of days with a GI symptom intensity score using an individual GI symptom scale [ Time Frame: 5 weeks ]
  2. Number of days with overall GI symptoms using a global GI symptom scale [ Time Frame: 5 weeks ]
  3. Worst GI symptom intensity by week using an individual GI symptom scale [ Time Frame: 5 weeks ]
  4. Safety will be measured by incidence of adverse events (AEs) [ Time Frame: 5 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of understanding and complying with the protocol
  • Has a confirmed diagnosis of RRMS
  • Neurologically stable with no evidence of relapse within 30 days prior to randomization
  • Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal
  • Additional criteria may apply

Exclusion Criteria:

  • Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
  • History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
  • History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
  • History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
  • Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
  • History of a myocardial infarction, including a silent myocardial infarction or unstable angina
  • History of clinically significant drug or alcohol abuse within the past year prior to screening
  • Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
  • Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
  • Prior use of Dimethyl Fumarate (DMF)
  • Additional criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093324


Contacts
Contact: Emily Rebecca Moore 512-904-4325 emilyrebecca.moore@syneoshealth.com

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Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03093324     History of Changes
Other Study ID Numbers: ALK8700-A302
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alkermes, Inc.:
Relapsing Remitting Multiple Sclerosis
RRMS
Multiple Sclerosis
MS
Alkermes
ALKS 8700
Dimethyl Fumarate
DMF
Tecfidera

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs