BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis (INSPIRE)

This study has been terminated.

(Sponsor Decision)

Sponsor:

Information provided by (Responsible Party):

Biogen

ClinicalTrials.gov Identifier:

NCT02430532

First received: April 27, 2015

Last updated: March 27, 2017

Last verified: March 2017

History of Changes

Results First Received: December 12, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator; Primary Purpose: Treatment
Condition:	Multiple Sclerosis, Secondary Progressive
Interventions:	Drug: dimethyl fumarate Other: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
Tecfidera 240 mg BID	BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.

Participant Flow: Overall Study

	Placebo	Tecfidera 240 mg BID
STARTED	30	28
COMPLETED	0	0
NOT COMPLETED	30	28
Sponsor Decision to Stop Study Early	30	25
Consent Withdrawn	0	2
Adverse Event	0	1

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
Tecfidera 240 mg BID	BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Tecfidera 240 mg BID	Total
Overall Participants Analyzed [Units: Participants]	30	28	58

Age [Units: Years] Mean (Standard Deviation)	50.7 (6.67)	49.6 (8.05)	50.2 (7.33)

Age, Customized [Units: Participants]
< 20 years	0	0	0
20 to 29 years	0	0	0
30 to 39 years	1	4	5
40 to 49 years	10	8	18
>= 50 years	19	16	35

Sex: Female, Male [Units: Participants] Count of Participants
Female	19 63.3%	17 60.7%	36 62.1%
Male	11 36.7%	11 39.3%	22 37.9%

Outcome Measures

Show All Outcome Measures

1. Primary:

Time to Disability Progression Independent of Relapse [ Time Frame: Up to 108 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) [ Time Frame: Baseline, 2 years ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline to Week 108 in ABILHAND Questionnaire Score [ Time Frame: Baseline, Week 108 ]

Show Outcome Measure 3

4. Secondary:

Percentage Change From Baseline to Week 108 in Whole Brain Volume [ Time Frame: Baseline, Week 108 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline, Week 108 ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early by the sponsor for business reasons. Efficacy, patient-reported outcomes, and pharmacodynamic data were not analyzed.

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.

Results Point of Contact:

Name/Title: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com

Responsible Party:	Biogen
ClinicalTrials.gov Identifier:	NCT02430532 History of Changes
Other Study ID Numbers:	109MS308 2014-003021-18 ( EudraCT Number )
Study First Received:	April 27, 2015
Results First Received:	December 12, 2016
Last Updated:	March 27, 2017

To Top