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Multiple SclerosisPhase 2NCT01006265

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

A Phase 2 study testing ACT-128800 Dose 1, ACT-128800 Dose 2 and ACT-128800 Dose 3 in people with Multiple Sclerosis, run by Actelion at 115 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
ACT-128800 Dose 1, ACT-128800 Dose 2 and ACT-128800 Dose 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
464 participants
Where
115 sitesin 23 countries
Study dates
1 Oct 2009to 1 Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

115 sites in 23 countries.

115 sites in 23 countries

United States25 sites

  • Clinical Investigator 3126

    Akron, Ohio, 44320

  • Clinical Investigative Site 3118

    Baltimore, Maryland, 21201

  • Clinical Investigative Site 3112

    Burlington, Vermont, 05401

  • Clinical Investigative Site 3113

    Cincinnati, Ohio, 45219

  • Clinical Investigative Site 3130

    Columbus, Ohio, 43221

  • Clinical Investigative Site 3101

    Indianapolis, Indiana, 46202

  • Clinical Investigative Site 3105

    Kansas City, Kansas, 66160

  • Clinical Investigative Site 3102

    Kirkland, Washington, 98034

  • Clinical Investigative Site 3129

    Latham, New York, 12110

  • Clinical Investigative Site 3107

    Lenexa, Kansas, 66214

  • Clinical Investigative Site # 3128

    New York, New York, 10032

  • Clinical Investigative Site # 3135

    Newark, New Jersey, 07103

  • Clinical Investigative Site 3125

    Philadelphia, Pennsylvania, 19107

  • Clinical Investigator 3104

    Portland, Oregon, 97225

  • Clinical Investigative Site 3119

    Raleigh, North Carolina, 27607

  • Clinical Investigative Site 3111

    Richmond, Virginia, 23298

  • Clinical Investigative Site 3115

    Sacramento, California, 95817

  • Clinical Invesigative Site 3116

    Sarasota, Florida, 34233

  • Clinical Investigative Site 3127

    Schenectady, New York, 12308

  • Clinical Investigative Site 3132

    Scottsdale, Arizona, 85259

  • Clinical Investigator 3136

    St Louis, Missouri, 63100

  • Clinical Investigative Site 3117

    Stanford, California, 94305

  • Clinical Investigative Site 3120

    Stony Brook, New York, 11794

  • Clinical Investigative Site 3100

    Tucson, Arizona, 85741

  • Clinical Investigative Site 3133

    Worcester, Massachusetts, 01605

Other trials in United States

Russia9 sites

  • Clinical Investigative Site # 3202

    Moscow, 127018

  • Clinical Investigative Site # 3203

    Nizhny Novgorod, 603155

  • Clinical Investigative Site # 3206

    Pyatigorsk, 357538

  • Clinical Investigative Site # 3204

    Saint Petersburg, 194354

  • Clinical Investigative Site 3201

    Saint Petersburg, 197022

  • Clinical Investigative Site 3200

    Saint Petersburg, 197376

  • Clinical Investigative Site # 3201

    Samara, 443095

  • Clinical Investigative Site 3209

    Saratov, 410030

  • Clinical Investigative Site 3208

    Ufa, 450005

Other trials in Russia

Germany7 sites

  • Clinical Investigative Site # 1806

    Bayreuth, 95445

  • Clinical Investigative 1807

    Berlin, 10117

  • Clinical Investigative Site 1803

    Berlin, 13347

  • Clinical Investigative site 1800

    Düsseldorf, 40225

  • Clinical Investigative Site 1802

    Essen, 45147

  • Clinical Investigative Site 1805

    Homburg/Saar, 66421

  • Clinical Investigative Site 1804

    Ulm, 89081

Other trials in Germany

Czechia6 sites

  • Clinical Investigative Site 1502

    Brno, 656 91

  • Clinical Investigative Site 1506

    Jihlava, 586 33

  • Clinical Investigative Site 1504

    Olomouc, 775 20

  • Clinical Investigative Site 1501

    Ostrava-Poruba, 70852

  • Clinical Investigative Site 1500

    Prague, 128 08

  • Clinical Investigative Site 1503

    Teplice

Other trials in Czechia

Hungary6 sites

  • Clinical Investigative Site 1905

    Budapest, 1134

  • Clinical Investigative Site # 1904

    Budapest, H-1115

  • Clinical Investigative Site 1908

    Budapest, H-1145

  • Clinical Investigative Site 1902

    Győr, 11-9024

  • Clinical Investigative Site 1900

    Petofi, 2500

  • Clinical Investigative Site 1901

    Szentpeteri-Kapu, 3526

Other trials in Hungary

Italy6 sites

  • Clinical Investigative Site 2101

    Gallarte, 21013

  • Clinical Investigative Site 2104

    Genova, 16132

  • Clinical Investigative Site # 2106

    Milan, 20132

  • Clinical Investigative Site 2102

    Padova, 35128

  • Clinical Investigative Site 2103

    Roma, 00189

  • Clinical Investigative Site 2105

    Siena, 53100

Other trials in Italy

Spain6 sites

  • Clinical Investigative Site 2706

    Barcelona, 08035

  • Clinical Investigative Site 2702

    Madrid, 28040

  • Clinical Investigative Site 2705

    Madrid, 28222

  • Clinical Investigative Site 2701

    Málaga, 29010

  • Clinical Investigative Site 2700

    Seville, 41009

  • Clinical Investigative Site 2704

    Valencia, 46009

Other trials in Spain

Belgium4 sites

  • Clinical Investigative Site 1201

    La Louvière, 7100

  • Clinical Investigative Site # 1205

    Liège, 4000

  • Clinical Investigative Site 1204

    Ottignies, 1340

  • Clinical Investigative Site 1203

    Sijsele-Damme, 8340

Other trials in Belgium

Bulgaria4 sites

  • Clinical Investigative Site 1302

    Sofia, 1309

  • Clinical Investigative Site 1301

    Sofia, 1431

  • Clinical Investigative Site 1303

    Varna, 9010

  • Clinical Investigative Site 1304

    Varna, 9010

Other trials in Bulgaria

Finland4 sites

  • Clinical Investigative Site 1600

    Helsinki, 00100

  • Clinical Investigative Site 1601

    Hyvinkää, 05800

  • Clinical Investigative Site 1603

    Tampere, 33520

  • Clinical Investigative Site 1602

    Turku, 20100

Other trials in Finland

Israel4 sites

  • Clinical Investigative Site 2000

    Ashkelon, 78278

  • Clinical Investigative Site 2003

    Tel Aviv, 64239

  • Clinical Investigative Site 2001

    Tel HaShomer, 52621

  • Clinical Investigative Site 2002

    Tsrifin, 70300

Other trials in Israel

Poland4 sites

  • Clinical Investigative Site 2305

    Katowice, 47-752

  • Clinical Investigative Site 2303

    Poznan, 60-355

  • Clinical Investigative Site 2304

    Warsaw, 02-957

  • Clinical Investigative Site 2302

    Wroclaw, 50-044

Other trials in Poland

Ukraine4 sites

  • Clinical Investigative Site 3302

    Chernihiv, 14029

  • Clinical Investigative Site 3303

    Dnipropetrovsk, 49044

  • Clinical Investigative Site 3300

    Kyiv, 03110

  • Clinical Investigative Site 3304

    Odesa, 65000

Other trials in Ukraine

Austria3 sites

  • Clinical Investigative Site 1102

    Amstetten, 3300

  • Clinical Investigative Site 1100

    Sankt Pölten, 3100

  • Clinical Investigative Site 1101

    Vienna, 1090

Other trials in Austria

Canada3 sites

  • Clinical Investigative Site 1401

    Burbaby, British Columbia, V5G 2X6

  • Clinical Investigative Site # 1401

    Burnaby, V5G 2X6

  • Clinical Investigative Site 1400

    Ottawa, K1H 8L6

Other trials in Canada

Netherlands3 sites

  • Clinical Investigative Site 2203

    Breda, 4818

  • Clinical Investigative Site 2202

    Nijmegen, 6533

  • Clinical Investigative Site 2201

    Sittard-Geleen, 6162

Other trials in Netherlands

Romania3 sites

  • Clinical Investigative Site 2400

    Bucharest, 022903

  • Clinical Investigative Site 2401

    Cluj-Napoca, 428063

  • Clinical Investigative Site 2402

    Timișoara, 300736

Other trials in Romania

Serbia3 sites

  • Clinical Investigative Site 2501

    Belgrade, 11000

  • Clinical Investigative Site 2503

    Kragujevac, 34000

  • Clinical Investigative Site 2502

    Niš, 18000

Other trials in Serbia

Sweden3 sites

  • Clinical Investigative Site 2802

    Gothenburg, 41345

  • Clinical Investigative Site 2800

    Stockholm, 17176

  • Clinical Investigative Site 2801

    Umed, 90185

Other trials in Sweden

United Kingdom3 sites

  • Clinical Investigative Site 3003

    Bristol, BS16 1LE

  • Clinical Investigative Site 3004

    Devon, PL6 SBX

  • Clinical Investigative Site 3002

    London, SE5 9RS

Other trials in United Kingdom

Australia2 sites

  • Clinical Investigative Site # 1001

    Fitzroy, 3065

  • Clinical Investigative Site 1000

    Westmead, 2145

Other trials in Australia

Switzerland2 sites

  • Clinical Investigative Site 2901

    Lugano, CH-6900

  • Clinical Investigative Site 2900

    Sankt Gallen, CH-9007

Other trials in Switzerland

France1 site

  • Clinical Investigative Site 1701

    Montpellier, 34295

Other trials in France

About this study

Official 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

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

Being tested
ACT-128800 Dose 1, Placebo, ACT-128800 Dose 2, ACT-128800 Dose 3
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-128800 Dose 1Drug

    ACT-128800 (Dose 1) administered orally once daily

  • PlaceboDrug

    Matching placebo administered orally once daily

  • ACT-128800 Dose 2Drug

    ACT-128800 (Dose 2) administered orally once daily

  • ACT-128800 Dose 3Drug

    ACT-128800 (Dose 3) administered orally once daily

Study groups in NCT01006265
Study groupRoleWhat they receive
ACT-128800 Dose 1ExperimentalACT-128800 Dose 1
Receives: Drug: ACT-128800 Dose 1
ACT-128800 Dose 2ExperimentalACT-128800 Dose 2
Receives: Drug: ACT-128800 Dose 2
ACT-128800 Dose 3ExperimentalACT-128800 Dose 3
Receives: Drug: ACT-128800 Dose 3
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 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.

    Measured: From Week 12 to 24

Secondary outcomes (2)

  1. Annualized Confirmed Relapse Rate

    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)

    Measured: Up to 24 weeks

  2. Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From 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.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2009 (estimated)
  2. Study start1 Oct 2009
  3. Primary completion1 Jun 2011
  4. Study completion1 Jul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01006265
Sponsor's protocol ID
AC-058B201
Status last verified
Mar 2025
First submitted
30 Oct 2009
Last updated
30 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 24659797

  • 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.

    PubMed 33914286

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACT-128800 Dose 1, ACT-128800 Dose 2 and ACT-128800 Dose 3 in people with Multiple Sclerosis, run by Actelion at 115 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Russia, Germany, Czechia, Hungary and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24 (time frame: From Week 12 to 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01006265, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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