A Phase 1 interventional study of Bafiertam and Tecfidera in Multiple Sclerosis, sponsored by Banner Life Sciences LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Banner Life Sciences LLC · Phase 1, Interventional, and Treatment
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 210 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Banner Life Sciences LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oral capsules administered twice daily
Drug: Bafiertam
oral capsules administered twice daily
Drug: Tecfidera
Over-encapsulated capsule to mask treatment
Also known as: monomethyl fumarate
Over-encapsulated capsule to mask treatment
Also known as: dimethyl fumarate
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
Time frame: 5 weeks
Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score
The MOGISS assesses global GI events (defined as one or more of the following symptoms: nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, constipation, bloating, and flatulence) and their effect on the patient during the 24 hours before each morning dose. The events items are rated on a 10-point numerical rating scale, where 0 = no events, 1 to 3 = mild events, 4 to 6 = moderate events, 7 to 9 = severe events, and 10 = extreme events. The MOGISS Total (sum of 8 scores) range is 0 (no symptoms) to 80 (worst possible symptoms) and the MOGISS Composite (average of 8 scores) range is 0 (no symptoms) - 10 (worst possible symptoms).
Time frame: 5 weeks
The number of days that a subject experiences at least one GI symptom.
Number of days with at (as reported on the MOGISS) with a severity score of at least 1
Time frame: 5 weeks
AUC in the MOGISS total score within in each subject over the treatment period
Defined as the daily total of all 8 individual symptom scores within each subject
Time frame: 5 weeks
Frequency, severity, and duration of overall GI events using the MOGISS.
Frequency, severity and duration of overall GI events will be completed using the MOGISS for each week of study treatment as well as for the overall study treatment period.
Time frame: 5 weeks
Safety and tolerability outcomes: incidence rates of all non GI-adverse events
Subject incidence rates of all non GI-adverse events
Time frame: 5 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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