MedTrace Logo

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

NCT01006265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2025-03-30

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

ACT-128800 Dose 1

ACT-128800 (Dose 1) administered orally once daily

DRUG

Placebo

Matching placebo administered orally once daily

DRUG

ACT-128800 Dose 2

ACT-128800 (Dose 2) administered orally once daily

DRUG

ACT-128800 Dose 3

ACT-128800 (Dose 3) administered orally once daily

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Pharmaceuticals · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2011-06-01
Completion
2011-07-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Sweden
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006265 on ClinicalTrials.gov