NCT00168701 is a Phase 2 clinical trial of BG00012 in Multiple Sclerosis, sponsored by Biogen.

Who is sponsoring NCT00168701?

NCT00168701 is sponsored by Biogen.

What drugs are being tested in NCT00168701?

Interventions in NCT00168701: BG00012.

What condition does NCT00168701 study?

NCT00168701 studies Multiple Sclerosis.

Is NCT00168701 still recruiting?

NCT00168701 is currently completed. Last updated 28 August 2023.

Last reviewed 2023-08-28 · How we verify

NCT00168701

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of BG00012 in MS

Completed Phase 2 Last updated 28 August 2023

What this trial tests

Phase 2 trial testing BG00012 in Multiple Sclerosis in 260 participants. Completed in 31 March 2006.

Timeline

1 October 2004

Primary endpoint
31 March 2006

31 March 2006

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	260
Start date	1 October 2004
Primary completion	31 March 2006
Estimated completion	31 March 2006
Sites	42 locations across Netherlands, Russia, Sweden, United Kingdom, Germany, Poland, Hungary, Switzerland

Drugs / interventions tested

BG00012

Conditions studied

Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
Kappos L, Gold R, Miller DH, Macmanus DG, et al · · 2008 · cited 337× · PMID 18970976 · DOI 10.1016/s0140-6736(08)61619-0
Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: Patient management considerations.
Fox RJ, Chan A, Gold R, Phillips JT, et al · · 2016 · cited 84× · PMID 27347439 · DOI 10.1212/cpj.0000000000000238
BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety.
Fox RJ, Kita M, Cohan SL, Henson LJ, et al · · 2014 · cited 82× · PMID 24131282 · DOI 10.1185/03007995.2013.849236
Dimethyl Fumarate and Its Esters: A Drug with Broad Clinical Utility?
Kourakis S, Timpani CA, de Haan JB, Gueven N, et al · · 2020 · cited 65× · PMID 33066228 · DOI 10.3390/ph13100306
Dimethyl fumarate for multiple sclerosis.
Xu Z, Zhang F, Sun F, Gu K, et al · · 2015 · cited 65× · PMID 25900414 · DOI 10.1002/14651858.cd011076.pub2
Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice.
Mehta D, Miller C, Arnold DL, Bame E, et al · · 2019 · cited 60× · PMID 30918100 · DOI 10.1212/wnl.0000000000007262
Monoclonal antibody therapy in multiple sclerosis: Paradigm shifts and emerging challenges.
Fontoura P. · · 2010 · cited 20× · PMID 21124072 · DOI 10.4161/mabs.2.6.13270
Lymphocyte reconstitution after DMF discontinuation in clinical trial and real-world patients with MS.
Chan A, Rose J, Alvarez E, Bar-Or A, et al · · 2020 · cited 13× · PMID 33510947 · DOI 10.1212/cpj.0000000000000800

Verify or expand the search:

Other trials of BG00012

Trials testing the same drug.

NCT00837785 — A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS · Phase 1 · completed

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00168701 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 28 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00168701.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing