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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01006265
Registration number
NCT01006265
Ethics application status
Date submitted
30/10/2009
Date registered
1/11/2009
Date last updated
7/02/2022
Titles & IDs
Public title
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
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Scientific title
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis
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Secondary ID [1]
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AC-058B201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ACT-128800 Dose 1
Treatment: Drugs - Placebo
Treatment: Drugs - ACT-128800 Dose 2
Treatment: Drugs - ACT-128800 Dose 3
Experimental: ACT-128800 Dose 1 - ACT-128800 Dose 1
Experimental: ACT-128800 Dose 2 - ACT-128800 Dose 2
Experimental: ACT-128800 Dose 3 - ACT-128800 Dose 3
Placebo comparator: Placebo - Matching placebo
Treatment: Drugs: ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
Treatment: Drugs: Placebo
Matching placebo administered orally once daily
Treatment: Drugs: ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
Treatment: Drugs: ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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From Week 12 to 24
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Secondary outcome [1]
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Annualized Confirmed Relapse Rate
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Assessment method [1]
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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)
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Timepoint [1]
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Up to 24 weeks
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Secondary outcome [2]
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Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to Week 24
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Anticipated
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Actual
1/07/2011
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Sample size
Target
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Final
464
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Recruitment in Australia
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Clinical Investigative Site # 1001 - Fitzroy
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Clinical Investigative Site 1000 - Westmead
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3065 - Fitzroy
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Actelion
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Ethics approval
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Summary
Brief summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
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Trial website
https://clinicaltrials.gov/study/NCT01006265
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Trial related presentations / publications
Olsson T, Boster A, Fernandez O, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1198-208. doi: 10.1136/jnnp-2013-307282. Epub 2014 Mar 21. Gisleskog PO, Valenzuela B, Scherz T, Burcklen M, Perez-Ruixo JJ, Poggesi I. An Exposure-Response Analysis of the Clinical Efficacy of Ponesimod in a Randomized Phase II Study in Patients with Multiple Sclerosis. Clin Pharmacokinet. 2021 Sep;60(9):1227-1237. doi: 10.1007/s40262-021-01020-2. Epub 2021 Apr 29.
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Public notes
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Contacts
Principal investigator
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Actelion Pharmaceuticals
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Actelion
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Olsson T, Boster A, Fernandez O, Freedman MS, Pozz...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT01006265
Download to PDF