BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS)

Multiple Sclerosis, Secondary Progressive Clinical Trial

— INSPIRE  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02430532
• Other study ID #: 109MS308
• Secondary ID: 2014-003021-18
• Status: Terminated
• Phase: Phase 3
• First received: April 27, 2015
• Last updated: April 9, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited States: Food and Drug AdministrationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Czech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with SPMS; The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

Key Inclusion Criteria:

• Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.

• Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.

• Have EDSS score of 3.0 to 6.5, inclusive.

• Have an multiple sclerosis (MS) Severity Score of 4 or higher.

Key Exclusion Criteria:

• Have a diagnosis of relapsing remitting multiple sclerosis (RRMS) or primary progressive MS as defined by the revised McDonald criteria.

• Had a recent clinical relapse (within 3 months) prior to randomization.

• Uncontrolled intercurrent illness including, but not limited to- ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Secondary Progressive
• Neoplasm Metastasis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
capsule (blue-white)

Other:
• Placebo
Matched placebo capsule (blue-white)

Locations

Country	Name	City	State
Belgium	Research Site	Bruxelles
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Kralove
Netherlands	Research Site	Sittard-Geleen
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Plewiska
Poland	Research Site	Poznan
Slovakia	Research Site	Banska Bystrica
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Long Beach	California
United States	Research Site	Round Rock	Texas
United States	Research Site	San Francisco	California
United States	Research Site	Tampa	Florida
United States	Research Site	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Netherlands,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of confirmed progression of disability as measured by worsening on one or more of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test (9HPT)	Confirmed progression of disability is defined as one or more of the following criteria, confirmed at a second visit =6 months later and at week 108 using one or more of the following assessments: EDSS score increased from baseline of = 1 point if baseline EDSS =5.5, or =0.5 point if Baseline EDSS =6.0; Timed 25-Foot Walk (T25FW): =20% increase from Baseline in the time taken for the 25-foot walk; Worsening on the 9-Hole Peg Test (9HPT): =20% increase from Baseline in the time taken for the 9HPT (increase must be confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.	Up to 108 weeks	No
Secondary	Change from Baseline to 2 years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)	MSWS-12 is a participant self-assessment of walking limitations due to multiple sclerosis (MS) during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater negative impact on walking.	Up to 108 weeks	No
Secondary	Change from Baseline to Week 108 in ABILHAND Questionnaire Score	The ABILHAND Questionnaire measures the participant's perceived difficulty in performing everyday manual activities in the last 3 months. Participants fill in the 56-item questionnaire by estimating their own difficulty or ease in performing each of the 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability.	Up to 108 weeks	No
Secondary	Percentage change from Baseline to Week 108 in whole brain volume	Whole brain volume is measured by magnetic resonance imaging (MRI)	Up to 108 weeks	No
Secondary	Change from Baseline to Week 108 in cognitive function as measured by the Symbol Digit Modalities Test (SDMT)	The SDMT measures the time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items from 0-110 in 90 seconds.	Up to 108 weeks	No