Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/IRCT201112267419N4
IRCT201112267419N4CompletedPhase 4

Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis

Osvah Pharmaceutical Company0 sites309 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
309
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 years to 65 years (—)
Sex
All

Inclusion Criteria

  • •Inclusion Criteria:
  • •1.Patients with Relapsing- Remitting Multiple Sclerosis (MS) based on McDonald's Criteria (2010)
  • •2. Age between 18-50 years old
  • •3.Expanded Disability Status Scale (EDSS) 0- 5.5
  • •4. Negative pregnancy test at baseline
  • •5.Signing consent form
  • •6. History of Chicken pox, VZV vaccination or positive antibody.
  • •7. At least one documented relapse during one year prior to study while on first line disease modifying therapies.
  • •8. No relapse during the last 30 days.
  • •Exclusion Criteria :
  • •1.Secondry or primary progressive MS
  • •2.History of a chronic disease other than MS
  • •3. History or presence of malignancy
  • •4. Macular edema at onset
  • •5. Active bacterial, fungal or viral infection
  • •6. Treatment with corticosteorids (IV) during the past 30 days
  • •7. Patients who have been previously treated with cyclophosphamide and mitoxantrone
  • •8.Patients who have been treated with immunoglubulins or monoclonal antibodies during the past six months
  • •9. Patients who have been treated with azothioprine or methtroxate during the past six months
  • •10. Patients who have been treated with beta- Interferon or GA during the past 3 months
  • •11.Medically Unstable patient according to site physician
  • •12. Patient with history of syncope
  • •13. History of cardiac arrest, heart failure, recurrent symptomatic bradycardia or ischemic heart disease
  • •14. Abnormal Electro Cardio Gram (ECG) (Block, QT interval more than 440 milliseconds on screening ECG
  • •15. Hypertension not controlled by prescribed medications
  • •16.Patients with severe respiratory disease, Active pulmonary disease, Tuberculosis except successful treatment or prophylactic treatment after positive purified protein derivative (PPD)
  • •17. Lost to follow up more than 3 months

Exclusion Criteria

  • Not provided

Investigators

Similar Trials

Completed
Not Applicable
A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptomsbenign prostatic hyperplasia
JPRN-UMIN000020369Hirosaki University Graduate School of Medicine200
Recruiting
Not Applicable
Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus LamivudineCertain infectious and parasitic diseases
KCT0000417Seoul National University Bundang Hospital180
Active, not recruiting
Phase 1
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.
EUCTR2006-000914-19-GBJanssen-Cilag International N.V.
Active, not recruiting
Phase 1
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.Anemia in cancer patients receiving chemotherapyMedDRA Version 5.1: list of preferred terma used in the process of defining thrombotic vascular events, see investigator's brochure epoetin alpha
EUCTR2006-000914-19-FRJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Active, not recruiting
Not Applicable
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. - ND
EUCTR2006-000914-19-ITJANSSEN-CILAG INTERNATIONAL NV500