Tecfidera Slow-titration Study

Multiple Sclerosis Clinical Trial

— TITRATION  

Official title:

A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02428231
• Other study ID #: 109MS416
• Secondary ID: 2014-004562-22
• Status: Terminated
• Phase: Phase 3
• First received: April 23, 2015
• Last updated: August 9, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlUnited States: Food and Drug AdministrationItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF)-related gastrointestinal (GI) Adverse Events (AEs) in subjects with Multiple Sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of dimethyl fumarate treatment in this study population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Diagnosis of MS consistent with locally labeled indication for dimethyl fumarate

• No prior treatment with dimethyl fumarate

• Female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study

• Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study

Key Exclusion Criteria:

• Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints

• Have other comorbid conditions that preclude participation in the study

• Participant is pregnant, breastfeeding, or planning a pregnancy during the study period

• Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, IFN-ß, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening

• History of severe allergic or anaphylactic reactions or known drug hypersensitivity

• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
Participants will be dosed twice daily for 12 weeks.

Locations

Country	Name	City	State
Belgium	Research Site	Leuven
Belgium	Research Site	Wilrijk
Czech Republic	Research Site	Praha 5
Italy	Research Site	Merano	Bolzano
Italy	Research Site	Montichiari	Brescia
United States	Research Site	Asheville	North Carolina
United States	Research Site	Auburn	Maine
United States	Research Site	Avon	Indiana
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Franklin	Indiana
United States	Research Site	Gilbert	Arizona
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Long Beach	California
United States	Research Site	Miami	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Phoenix	Arizona
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Wenatchee	Washington
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with worsening severity of gastrointestinal (GI) Adverse Events (AEs)	Positive average change from baseline to end of dimethyl fumarate treatment in the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It has been modified for daily recall in this study. The 7 severities of each of the 15 questions of the GSRS have a number assigned from 0 (no discomfort at all) to 6 (very severe discomfort).	6 weeks	No
Secondary	Average change from baseline in GSRS scores during dimethyl fumarate treatment		12 weeks	No
Secondary	Time to first worsening from baseline in GSRS score		14 weeks	No
Secondary	Time to recovery to baseline from last occurrence of worst GSRS score		14 weeks	No
Secondary	Average change from baseline in GSRS scores to the end of Weeks 4, 6, 8, 10, 12, and 14		14 weeks	No