Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

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Actelion Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: ACT-128800 Dose 3
Drug: ACT-128800 Dose 2
Drug: Placebo
Drug: ACT-128800 Dose 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01006265
AC-058B201

Details and patient eligibility

About

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Enrollment

464 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult males and females
  • Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
  • Signed inform consent prior to initiation of any study-mandated procedure.

Exclusion criteria

  • A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
  • Patients currently treated for an autoimmune disorder other than MS.
  • Contraindications for MRI.
  • Ongoing bacterial, viral, or fungal infection.
  • History or presence of malignancy.

Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

464 participants in 4 patient groups, including a placebo group

ACT-128800 Dose 1
Experimental group
Description:
ACT-128800 Dose 1
Treatment:
Drug: ACT-128800 Dose 1
ACT-128800 Dose 2
Experimental group
Description:
ACT-128800 Dose 2
Treatment:
Drug: ACT-128800 Dose 2
ACT-128800 Dose 3
Experimental group
Description:
ACT-128800 Dose 3
Treatment:
Drug: ACT-128800 Dose 3
Placebo
Placebo Comparator group
Description:
Matching placebo
Treatment:
Drug: Placebo

Trial contacts and locations

115

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Data sourced from clinicaltrials.gov

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