Efficacy and Safety of BG00012 in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168701
• Other study ID #: C-1900
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2004
• Est. completion date: March 31, 2006

Study information

• Verified date: August 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 31, 2006
• Est. primary completion date: March 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Must be 18 to 55 years old, inclusive, at the time of informed consent.

2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).

3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.

4. 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.

5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 [Appendix 3]).

2. History of malignancy.

3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.

4. 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.

5. History of human immunodeficiency virus (HIV).

6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.

7. 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.

8. Body weight >100 kg.

9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.

10. Any of the following abnormal blood tests at screening.

11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.

12. A medication history that precludes entry into the study.

13. Female subjects who are currently pregnant or breast-feeding.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BG00012

Locations

Country	Name	City	State
Czechia	Faculty Hospital St. Anne	Bmo
Czechia	Faculty Hospital	Hradec Kralove
Czechia	Hospital of Pardubice	Pardupice
Czechia	Faculty Hospital of Plzen	Plzen
Czechia	General Teaching Hospital	Prague
Germany	Bochum am St. Josef-Hospital	Bochum
Germany	Heinrich-Heine-Universitat	Dusseldorf
Germany	George-August-Universitat Goettigen	Goettigen
Hungary	Uzsoki Hospital	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Petz Aladar County Hospital	Gyor
Netherlands	VUMC	Amsterdam
Netherlands	Academic Hospital Rotterdam	Rotterdam
Poland	Niesalezny Zespol Opieki Zdrowognej	Bialystok
Poland	SamodzielnyPubliczny Szpital Kliniczny	Bialystok
Poland	10 Wojskowy Szpital Kliniczny z Poliklinika	Bydgoszcz
Poland	Wojewodzki Szpital Specjalistczny	Gdansk
Poland	Slaskiej Akademii Medycznej	Katowice-Ligota
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Panstwowy Szpital Kliniczny	Lodz
Poland	Samodzielny Publiczny Centralny Szpital	Warszawa
Sweden	MS Centrum	Molndal
Sweden	Karolinska University Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Switzerland	Kantonsspital Basel	Basel
Turkey	Hacettepe Unisersitesi	Ankara
Turkey	Istanbul University	Istanbul
Turkey	University of Instanbul	Istanbul
United Kingdom	Institute of Neurology	London
United Kingdom	Multiple Sclerosis Reseach Clinic	London
United Kingdom	Royal Hampshire Hospital	Sheffield
United Kingdom	University Hospital of North Staffordshire	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Czechia,  Germany,  Hungary,  Netherlands,  Poland,  Russian Federation,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.		Weeks 12, 16, 20, and 24
Secondary	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.		Weeks 24 and 48