Efficacy and Safety of BG00012 in MS

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00168701

Collaborator

(none)

260

Enrollment

Locations

Duration (Months)

6.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine the efficacy,safety, and tolerability of BG00012 in MS patients.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: BG00012	Phase 2

Detailed Description

The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Study Start Date :

Oct 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. []

Secondary Outcome Measures

The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be 18 to 55 years old, inclusive, at the time of informed consent.
Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 [Appendix 3]).
History of malignancy.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
History of human immunodeficiency virus (HIV).
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
Body weight >100 kg.
Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
Any of the following abnormal blood tests at screening.
Any previous treatment with FUMADERM®, FAG-201, or BG00012.
A medication history that precludes entry into the study.
Female subjects who are currently pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Faculty Hospital St. Anne	Bmo	Czech Republic	656 91
2	Faculty Hospital	Hradec Kralove	Czech Republic	500 05
3	Hospital of Pardubice	Pardupice	Czech Republic	532 03
4	Faculty Hospital of Plzen	Plzen	Czech Republic	304 60
5	General Teaching Hospital	Prague	Czech Republic	128 02
6	Bochum am St. Josef-Hospital	Bochum	Germany	44791
7	Heinrich-Heine-Universitat	Dusseldorf	Germany	40225
8	George-August-Universitat Goettigen	Goettigen	Germany	37073
9	Uzsoki Hospital	Budapest	Hungary	1145
10	University of Debrecen	Debrecen	Hungary	4012
11	Petz Aladar County Hospital	Gyor	Hungary	9024
12	VUMC	Amsterdam	Netherlands	1081 HV
13	Academic Hospital Rotterdam	Rotterdam	Netherlands	3015 GD
14	SamodzielnyPubliczny Szpital Kliniczny	Bialystok	Poland	15-276
15	Niesalezny Zespol Opieki Zdrowognej	Bialystok	Poland	15-420
16	10 Wojskowy Szpital Kliniczny z Poliklinika	Bydgoszcz	Poland	85-681
17	Wojewodzki Szpital Specjalistczny	Gdansk	Poland	80-803
18	Slaskiej Akademii Medycznej	Katowice-Ligota	Poland	41-741
19	Szpital Uniwersytecki w Krakowie	Krakow	Poland	31-503
20	Panstwowy Szpital Kliniczny	Lodz	Poland	90-153
21	Samodzielny Publiczny Centralny Szpital	Warszawa	Poland	01-097
22		Moscow	Russian Federation	1153682
23		Moscow	Russian Federation	123182
24		Moscow	Russian Federation	123367
25		Moscow	Russian Federation	127018
26		Novgorod	Russian Federation	603076
27		Novosibirsk	Russian Federation	630075
28		St. Petersburg	Russian Federation	194044
29		St. Petersburg	Russian Federation	194291
30		St. Petersburg	Russian Federation	197022
31		St. Petersburg	Russian Federation	197376
32	MS Centrum	Molndal	Sweden	431 80
33	Karolinska University Hospital	Stockholm	Sweden	141 86
34	Karolinska University Hospital	Stockholm	Sweden	171 76
35	Kantonsspital Basel	Basel	Switzerland	CH 4.31
36	Hacettepe Unisersitesi	Ankara	Turkey	6100
37	Istanbul University	Istanbul	Turkey	34303
38	University of Instanbul	Istanbul	Turkey	TR-34390
39	Multiple Sclerosis Reseach Clinic	London	United Kingdom	SE1 9RT
40	Institute of Neurology	London	United Kingdom	WC1N 3BG
41	Royal Hampshire Hospital	Sheffield	United Kingdom	S10 2JF
42	University Hospital of North Staffordshire	Stoke-on-Trent	United Kingdom	ST4 7LN