Clinical trials: Clinically Isolated Syndrome
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, Relapsing-Remitting, Clinically Isolated Syndrome
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
- Trial name
- OLTERMS (NCT00595920)
- Testing
- Tovaxin
- Where
- 27 sites in United States
- Volunteers
- 116 people
- Sponsor
- Opexa Therapeutics, Inc.
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of…
- Trial name
- MINORE (NCT04998812)
- Testing
- Ocrelizumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
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 Syndrome
Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)
REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a…
- Trial name
- REFLEXION (NCT00813709)
- Testing
- RNF
- Where
- 57 sites in Argentina, Austria and 22 more
- Volunteers
- 402 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Sclerosis
Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body.
- Trial name
- STAYCIS (NCT00094172)
- Testing
- Atorvastatin
- Where
- 14 sites in United States, Canada
- Volunteers
- 82 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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