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NCT00963833
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
trial testing Interferon beta-1b (Betaseron, BAY86-5046) in Multiple Sclerosis in 68 participants. Completed in 1 September 2016.
12 April 2016
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 68 |
| Start date | 17 December 2009 |
| Primary completion | 12 April 2016 |
| Estimated completion | 1 September 2016 |
| Sites | 6 locations across Finland, Belgium, Austria, United Kingdom, Israel, Germany |
Drugs / interventions tested
- Interferon beta-1b (Betaseron, BAY86-5046) — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Bayer — full company profile →
Who can join
Adults 12 to 16, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years. The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions. As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multiple Sclerosis in Children: Differential Diagnosis, Prognosis, and Disease-Modifying Treatment.
Jakimovski D, Awan S, Eckert SP, Farooq O, et al · · 2022 · cited 42× · PMID 34940954 · DOI 10.1007/s40263-021-00887-w -
Children with multiple sclerosis should not become therapeutic hostages.
Rose K, Müller T. · · 2016 · cited 17× · PMID 27582894 · DOI 10.1177/1756285616656592 -
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
Verify or expand the search:
- PubMed search for NCT00963833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Interferon beta-1b (Betaseron, BAY86-5046)
Trials testing the same drug.
- NCT02652091 — Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction · completed
- NCT01491100 — Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis · completed
- NCT03408093 — Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b · 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 Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · 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 NCT00963833 (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 Bayer
- Last refreshed: 12 July 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/NCT00963833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing