Last reviewed · How we verify
NCT02579681: StarTec
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
Phase 3 trial testing dimethyl fumarate in Multiple Sclerosis, Relapsing-Remitting in 221 participants. Completed in 21 December 2016.
21 December 2016
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 221 |
| Start date | 30 April 2014 |
| Primary completion | 21 December 2016 |
| Estimated completion | 21 December 2016 |
| Sites | 18 locations across Italy |
Drugs / interventions tested
- dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →
Conditions studied
- Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
Sponsor
Biogen — full company profile →
Who can join
18 and older, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02579681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of dimethyl fumarate
Trials testing the same drug.
- NCT06850597 — Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's D · Phase 2 · recruiting
- NCT02969304 — Study of Utilization Patterns of Dimethyl Fumarate in Germany · completed
- NCT02555215 — Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) · Phase 3 · completed
- NCT02471560 — Tecfidera and the Gut Microbiota · Phase 4 · completed
- NCT02410200 — Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS · Phase 2 · completed
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
- NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap · Phase 3 · recruiting
- NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis · NA · recruiting
- NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis · NA · recruiting
- NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients · active not recruiting
- NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02579681 (US National Library of Medicine, public domain)
- 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: 27 April 2017
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/NCT02579681.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing