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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: ACT-128800 Dose 1; Drug: ACT-128800 Dose 2; Drug: ACT-128800 Dose 3; Drug: Placebo

• Registration Number: NCT01006265
• Lead Sponsor: Actelion

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2011-06-01
• Study Completion: 2011-07-01
• Disposition First Submitted: 2012-09-27
• Disposition First Submitted QC: 2012-09-27
• Disposition First Posted: 2012-10-01
• Results First Submitted: 2021-04-01
• Results First Submitted QC: 2021-05-18
• Results First Posted: 2021-06-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT-128800 Dose 1	ACT-128800 Dose 1	ACT-128800 Dose 1
ACT-128800 Dose 2	ACT-128800 Dose 2	ACT-128800 Dose 2
ACT-128800 Dose 3	ACT-128800 Dose 3	ACT-128800 Dose 3
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24	From Week 12 to 24	Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24	Baseline to Week 24	Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.
Annualized Confirmed Relapse Rate	Up to 24 weeks	Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)

Trial Locations

Locations (115)

Clinical Investigative Site 3132; 🇺🇸 Scottsdale, Arizona, United States

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

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