Clinical trials: Clinically Isolated Syndrome (CIS)
Relapsing-Remitting Multiple Sclerosis
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).
- Trial name
- TERMS (NCT00245622)
- Testing
- Tovaxin Autologous T cell vaccine
- Where
- 33 sites in United States
- Volunteers
- 150 people
- Sponsor
- Opexa Therapeutics, Inc.
Positron-Emission Tomography, Multiple Sclerosis
Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
- Trial name
- NCT01031199
- Testing
- F-18 FEDAA1106 (BAY85-8101)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Multiple Sclerosis
Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome
The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during…
- Trial name
- PreCISe (NCT00666224)
- Testing
- Glatiramer Acetate (DB), Glatiramer Acetate (OL)
- Volunteers
- 481 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Multiple Sclerosis
Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study
The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness…
- Trial name
- PROmyBETAapp (NCT03134573)
- Testing
- Interferon beta-1b (Betaferon, BAY86-5046), Betaconnect auto-injector, myBETAapp
- Where
- Germany
- Volunteers
- 96 people
- Sponsor
- Bayer
Multiple Sclerosis
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
- Trial name
- ENCORE (NCT01167426)
- Testing
- Glatiramer Acetate 20 mg/0.5 mL
- Volunteers
- 148 people
- Sponsor
- Teva Neuroscience, Inc.
Clinically Isolated Syndrome
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) …
- Trial name
- CIS-ON (NCT00287079)
- Testing
- Rebif®, No Treatment
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or…
- Trial name
- PROCEED (NCT02254304)
- Testing
- Rebif
- Where
- Germany
- Volunteers
- 106 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Sclerosis
Oral Cladribine in Early Multiple Sclerosis (MS)
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome).
- Trial name
- ORACLE MS (NCT00725985)
- Testing
- Cladribine, Rebif® new formulation (RNF)
- Where
- 158 sites in United States, Argentina and 32 more
- Volunteers
- 617 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis, Clinically Isolated System
Betaferon® Regulatory Post-Marketing Surveillance
To identify problems/questions about following items in the clinical practice using Betaferon 1. Unknown adverse event (especially serious adverse event) 2. Identification of adverse event occurred in the real practice 3.
- Trial name
- NCT01414816
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- South Korea
- Volunteers
- 355 people
- Sponsor
- Bayer
Relapsing Remitting Multiple Sclerosis (RRMS)
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS).
- Trial name
- BEACON (NCT00787657)
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- 36 sites in Argentina, Bahrain and 34 more
- Volunteers
- 1,723 people
- Sponsor
- Bayer
Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol.
- Trial name
- NCT01039103
- Testing
- PEG-liposomal prednisolone sodium phosphate, Methylprednisolone
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 15 people
- Sponsor
- Lakefront Biotherapeutics NV
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with…
- Trial name
- SOPRANINO (NCT04998851)
- Testing
- Ocrelizumab
- Where
- 8 sites in United States, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical…
- Trial name
- TOPIC (NCT00622700)
- Testing
- Teriflunomide
- Where
- 131 sites in United States, Australia and 19 more
- Volunteers
- 618 people
- Sponsor
- Sanofi
Multiple Sclerosis (MS), Relapsing-Remitting MS
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients.
- Conditions
- Multiple Sclerosis (MS), Relapsing-Remitting MS, Primary Progressive MS, Secondary Progressive MS
- Trial name
- LOMBARD (NCT01804647)
- Testing
- No study treatments administered - blood draws only
- Where
- 4 sites in France, Spain and 1 more
- Volunteers
- 58 people
- Sponsor
- GeNeuro Innovation SAS
Optic Neuritis
Atacicept in Subjects With Optic Neuritis
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS.
- Trial name
- NCT00624468
- Testing
- Atacicept
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 34 people
- Sponsor
- EMD Serono
Multiple Sclerosis
An Observational Study on the Progression of Clinically Isolated Syndrome to Multiple Sclerosis Over a 2-year Period
This is a prospective, multicentric, observational study with a 2 years recruitment period. The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects since their first episode of neurological…
- Trial name
- NEO (NCT01112657)
- Where
- 6 sites in Taiwan
- Volunteers
- 154 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Sclerosis
Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive…
- Trial name
- ADHERENCE (NCT03408093)
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Volunteers
- 120 people
- Sponsor
- Bayer