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

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT01006265

Run by

Actelion

People needed

464

Starts

2009-10-01

Expected to finish

2011-07-01

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Investigative Site 3100 — Tucson, Arizona, United States
• Clinical Investigative Site 3115 — Sacramento, California, United States
• Clinical Investigative Site 3117 — Stanford, California, United States
• Clinical Invesigative Site 3116 — Sarasota, Florida, United States
• Clinical Investigative Site 3101 — Indianapolis, Indiana, United States
• Clinical Investigative Site 3105 — Kansas City, Kansas, United States
• Clinical Investigative Site 3107 — Lenexa, Kansas, United States
• Clinical Investigative Site 3118 — Baltimore, Maryland, United States
• Clinical Investigative Site 3133 — Worcester, Massachusetts, United States
• Clinical Investigator 3136 — St Louis, Missouri, United States
• Clinical Investigative Site # 3135 — Newark, New Jersey, United States
• Clinical Investigative Site 3129 — Latham, New York, United States
• Clinical Investigative Site # 3128 — New York, New York, United States
• Clinical Investigative Site 3127 — Schenectady, New York, United States
• Clinical Investigative Site 3120 — Stony Brook, New York, United States
• Clinical Investigative Site 3119 — Raleigh, North Carolina, United States
• Clinical Investigator 3126 — Akron, Ohio, United States
• Clinical Investigative Site 3113 — Cincinnati, Ohio, United States
• Clinical Investigative Site 3130 — Columbus, Ohio, United States
• Clinical Investigator 3104 — Portland, Oregon, United States
• Clinical Investigative Site 3125 — Philadelphia, Pennsylvania, United States
• Clinical Investigative Site 3112 — Burlington, Vermont, United States
• Clinical Investigative Site 3111 — Richmond, Virginia, United States
• Clinical Investigative Site 3102 — Kirkland, Washington, United States
• Clinical Investigative Site 3132 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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