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Betaseron Medical Research Studies

Up-to-date List of Betaseron Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Betaseron Medical Research Studies

Rank Status Study
1 Not yet recruiting BAY86-5046 (Betaseron), Non Interventional Studies
Condition: Multiple Sclerosis
Interventions: Drug: Interferon beta-1b (Betaferon, BAY 86-5046);   Device: BETACONNECT auto-injector.
Outcome Measures: Adherence measure to Betaferon therapy based on the real BETACONNECT injections;   Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire;   Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire;   Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS);   Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D);   Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC);   Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT);   Local skin reactions recorded by Health Care Provider (HCP) evaluation;   Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device;   Number of Treatment-emergent Adverse Events (TEAE)
2 Recruiting Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)
Condition: Multiple Sclerosis
Intervention: Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Outcome Measures: Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation;   Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS;   Change from baseline of daily activities impairment of patients with FLS, based on patient's self assessment using four categories;   Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period;   MS patient with Flu-Like Symptoms (FLS) demographic profile.
3 Recruiting Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon
Condition: Multiple Sclerosis
Intervention: Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Outcome Measures: Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI);   Fatique assessed by the Modified Fatigue Impact Scale (MFIS);   Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS);   Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS);   Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL);   Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.;   Safety variables will be summarized using descriptive statistics based on adverse events collection
4 Recruiting MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)
Condition: Multiple Sclerosis
Interventions: Drug: Verum arm receiving Gilenya®;   Drug: Active Comparator receiving Extavia®
Outcome Measure: Efficacy parameters
5 Recruiting Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Outcome Measures: Cognitive performance as measured by SDMT (Symbol Digit Modalities Test);   Physical activity as measured by the Baecke questionnaire;   Disability as measured by EDSS (Expanded Disability Status Scale);   Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions);   Depression as measured by the CES-D (Center for Epidemiologic Studies Depression);   Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)
6 Recruiting Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study
Condition: Multiple Sclerosis
Interventions: Procedure: Hematopoietic Stem Cell Therapy;   Drug: Standard treatment with a conventional drug
Outcome Measure: EDSS
7 Recruiting Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
Condition: Multiple Sclerosis
Intervention: Drug: Anesthetic Topical Adhesive Synera
Outcome Measures: Pain Rating;   Average pain rating
8 Recruiting Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma
Conditions: Recurrent Neuroendocrine Carcinoma of the Skin;   Stage IV Neuroendocrine Carcinoma of the Skin
Interventions: Radiation: radiation therapy;   Biological: recombinant interferon beta;   Biological: MCPyV TAg-specific polyclonal autologous CD8-positive T cell vaccine;   Biological: aldesleukin;   Other: laboratory biomarker analysis
Outcome Measures: Evidence and nature of toxicity related to the study treatment assessed using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0;   Evidence of response based on "median time to new metastasis";   Persistence of transferred T cells in blood and in tumor;   Functional capacity of transferred T cells;   Disease response by RECIST criteria;   MCC-specific survival
9 Recruiting Patients With RRMS:Candidates for MS Therapy Change
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Fingoliomod;   Drug: Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Outcome Measures: Primary objective is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the TSQM-9.;   Evaluate safety and tolerability immediately after a change in DMT and during 6 months of treatment with fingolimod vs. DMT standard of care in patients who have been previously treated for RRMS.;   Evaluate the change in patient-reported Activities of Daily Living (ADL) with fingolimod vs. DMT standard of care, using the Multiple Sclerosis Activities Scale (PRIMUS-Activities), in patients who have been previously treated for RRMS.;   Evaluate the change in patient-reported fatigue with fingolimod vs. DMT standard of care, using the Fatigue Severity Scale (FSS), in patients who have been previously treated for RRMS.;   Evaluate changes in patient-reported effectiveness and convenience subscales with fingolimod vs. DMT standard of care, using the TSQM-9, in patients who have been previously treated for RRMS.;   Evaluate the change in patient-reported depression with fingolimod vs. DMT standard of care, using the Beck Depression Inventory Fast Screen (BDI-FS), in patients who have been previously treated for RRMS.
10 Unknown  Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Other: Physical exercise training
Outcome Measures: Multiple Sclerosis Fatigue;   Quality of Life;   Injection site visual analog scale (0-10)
11 Recruiting Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
Conditions: Multiple Sclerosis, Primary Progressive;   Multiple Sclerosis, Secondary Progressive
Interventions: Drug: ibudilast;   Drug: Placebo
Outcome Measures: Covariate-adjusted mean rate of change in brain atrophy over 96 weeks as measured by brain parenchymal fraction (BPF).;   Safety Measures: TEAEs (treatment-emergent adverse events), TESAEs (treatment-emergent serious adverse events), treatment discontinuations due to TEAEs, laboratory measures (chemistry, hematology, urinalysis), vital signs, electrocardiograms (ECGs).;   Diffusion tensor imaging (DTI) in descending pyramidal white matter tracts;   Magnetization transfer ratio (MTR) imaging in normal-appearing brain tissue;   Retinal nerve fiber layer as measured by Optical coherence tomography (OCT);   Cortical atrophy as measured by cortical longitudinal atrophy detection algorithm [CLADA];   Inflammatory disease activity, as measured by T1 lesion volume, T2 lesion volume, and annualized relapse rate;   Disability, as measured by Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC);   Quality of Life, as measured by Multiple Sclerosis Impact Scale (MSIS-29), EuroQol 5 Dimensions (EQ-5D), and Short Form-36 Health Survey (SF-36);   Cognitive impairment, as measured by Symbol Digit Modalities Test (SDMT) and the Selective Reminding Test (SRT).;   Neuropathic pain, as measured by Brief Pain Inventory (BPI)
12 Unknown  Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
Conditions: Multiple Sclerosis;   Cognitive Impairment
Outcome Measures: Multiple Sclerosis Inventory Cognition (MUSIC);   Annual Corpus Callosum Index decrease;   Corpus callosum Index at baseline;   Time to clinically definite MS;   The Symbol Digit Modalities Test (SDMT);   Ratio treatment duration to disease duration
13 Recruiting Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Fingolimod;   Drug: Disease Modifying therapy
Outcome Measures: Retention on treatment;   Reasons for Discontinuation;   Adverse events;   Cognitive impairment;   Percent change in brain volume;   Treatment satisfaction

These studies may lead to new treatments and are adding insight into Betaseron etiology and treatment.

A major focus of Betaseron research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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