OPTIMUM-LT: Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

• Sponsor: Actelion (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03232073
• Collaborator: (none)
• Enrollment: 869
• Locations: 148
• Arm: 1
• Anticipated Duration (Months): 80.1
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Ponesimod	Phase 3

Detailed Description

The AC-058B303 study (extension study) is the long-term extension for the AC-058B301 study (core study). The core study has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with RMS. The subjects are treated with either ponesimod or the active comparator, teriflunomide in the core study. The purpose of this long term extension of the core study is to characterize the long-term safety and control of disease of ponesimod in subjects with RMS. In particular, the study will allow to observe potential adverse events which may only occur after long term treatment with ponesimod. The study will also investigate the effect of re-initiation of ponesimod after a brief interruption in a relatively large population (all subjects treated with ponesimod in the core study and eligible for the extension study) on disease activity in terms of relapses and MS-related MRI lesions. There is currently limited guidance on when a new MS treatment should be started after discontinuation of teriflunomide and the study will contribute with data on safety and efficacy of switching from teriflunomide to ponesimod after an interruption as mandated by the protocol. The study will also allow confirmation of sustained efficacy of ponesimod in terms of relapses, MRI lesions and reduction of disability accumulation during long-term treatment. In addition, combined data from the core study together with the results of the current extension study will allow comparison of MS activity in subjects who were switched from teriflunomide to ponesimod versus those who were treated with ponesimod in both studies. A vaccination sub-study will be conducted in a sub-set of up to 50 eligible study participants from selected countries who consent to be vaccinated with the Janssen coronavirus disease-2019 (COVID-19) vaccine (Ad26.COV2.S) to investigate the immune response induced by the Janssen COVID-19 vaccine.

Study Design

• Study Type: Interventional
• Actual Enrollment: 869 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a single-group open-label extension study to investigate long-term safety, tolerability and control of disease of ponesimod 20 mg in subjects with RMS. Statistical analyses will be descriptive and therefore all endpoints are exploratory in nature. All exploratory endpoints are listed under primary outcomes.This is a single-group open-label extension study to investigate long-term safety, tolerability and control of disease of ponesimod 20 mg in subjects with RMS. Statistical analyses will be descriptive and therefore all endpoints are exploratory in nature. All exploratory endpoints are listed under primary outcomes.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis
• Actual Study Start Date: Jul 5, 2017
• Anticipated Primary Completion Date: Feb 16, 2024
• Anticipated Study Completion Date: Mar 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ponesimod 20 mg administered orally once daily	Drug: Ponesimod; Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15

Outcome Measures

Primary Outcome Measures

1. Annualized confirmed relapse rate (ARR) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   defined as the number of confirmed relapses per subject-year

2. Time from core study randomization to first confirmed relapse [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Time from enrollment in core study to first confirmed relapse

3. Time to first 12-week confirmed disability accumulation (CDA) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Time from core baseline to first 12-week CDA

4. Time to first 24-week confirmed disability accumulation (CDA) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Time from core baseline to first 24-week CDA

5. Patients with absence of relapses [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Number of patients with absence of relapses during study period

6. Change from baseline in Expanded Disability Status Scale (EDSS) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Change from baseline in EDSS at all assessments

7. Assessment of no evidence of disease activity (NEDA) status at end-of-study (EOS) according to NEDA 3 [Up to 354 weeks]

   NEDA 3 defined by the absence of confirmed relapse, GD+ T1 lesions, new or enlarging T2 lesions and 12-week CDA

8. Assessment of no evidence of disease activity (NEDA) status at EOS according to NEDA 4 [Up to 354 weeks]

   NEDA 4 defined by the absence of confirmed relapse, GD+ T1 lesions, new or enlarging T2 lesions and 12-week CDA, and annual brain volume change ≥ -0.4% from baseline to all assessments

9. Percent change from baseline in brain volume (PCBV) measured by magnetic resonance imaging (MRI) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

   Change from baseline in brain volume at all assessments

10. Cumulative number of combined unique active lesions (CUAL) measured by MRI [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Cumulative number of combined unique active lesions (CUAL) defined as new Gd+ T1 lesions plus new or enlarging T2 lesions (without double-counting the lesions) at all assessments

11. Determination of number of Gd+ T1 lesions by MRI [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Number of Gd+ T1 lesions at all assessments

12. Cumulative number of new or enlarging T2 lesions measured by MRI [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Cumulative number of new or enlarging T2 lesions (relative to baseline) at all assessments

13. Assessment of volume of brain lesions measured by MRI [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Determination of MRI lesions (T2 lesions, T1 hypointense lesions) at all assessments

14. Absence of MRI lesions [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Absence of MRI lesions (Gd+ T1 lesions, new or enlarging T2 lesions) at all assessments

15. Determination of proportion of Gd+ lesions at baseline evolving to persistent black holes (PBHs) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Proportion of Gd+ lesions at baseline evolving to PBHs at all assessments

16. Estimation of incidence rates of adverse events (AEs) [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Incidence rates of treatment-emergent AEs, severe AEs, AEs of special interest and AEs leading to premature discontinuation of study treatment

17. Estimation of incidence rates of treatment-emergent morphological ECG abnormalities [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    ECG abnormalities as defined by the ECG provider

18. Assessment of cardiac rhythms measured by electrocardiogram (ECG) parameters [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Absolute values by visit for 12-lead ECG parameters (HR, PR, QRS, QT, QTcB, QTcF)

19. Change from baseline values by visit for cardiac rhythms [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Change from baseline values by visit for ECG parameters (HR, PR, QRS, QT, QTcB, QTcF)

20. Change in ECG parameters from pre-dose to selected post-dose assessments [Analysis period: From day 1 in extension study to end-of-treatment (EOT) in extension study, i.e. for up to 240 weeks]

    Change in ECG parameters (HR, PR, QRS, QT, QTcB, QTcF) from pre-dose to selected post-dose assessments (1h, 2h, 3h, 4h) on day 1 of extension study and on day of re-initiation of study treatment

21. Absolute values and percent change from baseline in forced expiratory volume and forced vital capacity [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Absolute values and percent change from baseline in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) at all assessments

22. Assessment of treatment-emergent decrease from baseline in forced expiratory volume and forced vital capacity [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Determination of treatment-emergent decrease from baseline in FEV1 and FVC (absolute and % of predicted)

23. Absolute change from baseline to end-of-study (EOS) versus change from baseline to end-of-treatment (EOT) in forced expiratory volume and forced vital capacity [Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks]

    Absolute change from baseline to end-of-study (EOS) versus change from baseline to end-of-treatment (EOT) in FEV1 and FVC (absolute and % of predicted)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed informed consent

2. Subjects with MS having completed the double-blind treatment in the core study as scheduled

3. Compliance with teriflunomide elimination procedure

4. Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom.

Exclusion Criteria:

1. Any of the following cardiovascular conditions on Day 1 pre-dose:

2. Resting heart rate (HR) < 50 bpm;

3. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males);

4. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study:

5. Lymphocyte count: < 0.2 x 109/L;

6. Neutrophil count <1.0 × 109/L;

7. Platelet count < 50 × 109/L;

8. Creatinine clearance < 30 mL/min

9. At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC;

10. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study.

11. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study.

12. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose:

13. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug;

14. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms.

15. Need for and intention to administer forbidden study treatment-concomitant therapy

16. Women who are pregnant or lactating.

17. Male subjects wishing to parent a child;

18. Treatment with any MS Disease Modifying Therapies;

19. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study;

20. Subjects unlikely to comply with the extension study protocol based on investigator best judgment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Research Center of Southern California, LLC	Carlsbad	California	United States	92011
2	The Neurology Group	Pomona	California	United States	91767
3	Mountain View Clinical Research	Denver	Colorado	United States	80209
4	Neurology Associates of Ormond Beach	Ormond Beach	Florida	United States	32174
5	University of South Florida	Tampa	Florida	United States	33612
6	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana	United States	46256
7	Raleigh Neurology Associates	Raleigh	North Carolina	United States	27607
8	Ohio Health	Columbus	Ohio	United States	43214
9	Advanced Neurosciences Institute	Franklin	Tennessee	United States	37064
10	Grodno University Hospital	Grodno		Belarus	230017
11	Minsk City Clinical Hospital 5	Minsk		Belarus	220026
12	Republican Scientific Clinical Centre	Minsk		Belarus	220114
13	Vitebsk Regional Diagnostic Center	Vitebsk		Belarus	210023
14	Vitebsk Regional Clinical Hospital	Vitebsk		Belarus	210037
15	University Clinicl Center Sarajevo	Sarajevo		Bosnia and Herzegovina	71000
16	UMHAT Sveti Georgi	Plovdiv		Bulgaria	4002
17	Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Nuam	Sofia		Bulgaria	1113
18	Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead	Sofia		Bulgaria	1309
19	Acibadem City Clinic Tokuda Hospital	Sofia		Bulgaria	1407
20	St Ivan Rilski University Multiprofile Hospital For Active Treatment	Sofia		Bulgaria	1431
21	University Multiprofile Hospital for Active Treatment Alexandrovska EAD	Sofia		Bulgaria	1431
22	Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia	Sofia		Bulgaria	1606
23	University of Alberta	Edmonton	Alberta	Canada	T6G 1Z1
24	Royal Jubilee Hospital	Victoria	British Columbia	Canada	V8R 1J8
25	Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
26	Recherche Sepmus Inc.	Greenfield Park	Quebec	Canada	J4V 2J2
27	Ch Osijek	Osijek		Croatia	31000
28	University Hospital Center Zagreb	Zagreb		Croatia	10000
29	Fakultní nemocnici Brno	Brno		Czechia	65691
30	Fakultni nemocnice Hradec Kralove	Hradec Králové		Czechia	500 05
31	Nemocnice Jihlava	Jihlava		Czechia	586 33
32	Fakultni nemocnice Ostrava	Ostrava-Poruba		Czechia	708 52
33	Pardubicka krajska nemocnice a.s.	Pardubice		Czechia	532 03
34	Vseobecna Fakultní Nemocnice	Praha 2		Czechia	128 08
35	FN Motol	Praha 5		Czechia	150 06
36	Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.	Teplice		Czechia	415 29
37	Suomen Terveystalo Tampere	Tampere		Finland	33100
38	Mehilainen NEO	Turku		Finland	20520
39	Hôpital Pellegrin CHU Bordeaux	Bordeaux cedex		France	33076
40	CHU Clermont-Ferrand - Hopital Gabriel Montpied	Clermont Ferrand Cedex 1		France	63003
41	Hôpital Nord Laennec - CHU NANTES	Nantes Cedex 1		France	44093
42	Hopital PASTEUR	Nice		France	6000
43	Nouvel Hôpital Civil	Strasbourg CEDEX		France	67091
44	LTD 'Aversi Clinic'	T'bilisi		Georgia	0160
45	P. Sarajishvili Institute of Neurology	Tbilisi		Georgia	112
46	Pineo Medical Ecosystem Ltd	Tbilisi		Georgia	114
47	S.Khechinashvili University Hospital	Tbilisi		Georgia	179
48	Curatio, Jsc	Tbilisi		Georgia	186
49	Universitätsklinikum Carl-Gustav-Carus Dresden	Dresden		Germany	1307
50	Helios Klinikum Erfurt	Erfurt		Germany	99089
51	Panakeia - Arzneimittelforschung GmbH	Leipzig		Germany	04275
52	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz		Germany	55131
53	401 Military Hospital	Athens		Greece	115 25
54	Naval Hospital of Athens	Athens		Greece	11521
55	Medical Center of Athens	Marousi		Greece	15125
56	Uzsoki Utcai Korhaz	Budapest		Hungary	1145
57	Jahn Ferenc Del-pesti Korhaz es Rendelointezet	Budapest		Hungary	1204
58	Valeomed EGÉSZSÉGÜGYI KÖZPONT	Esztergom		Hungary	2500
59	Petz Aladar Megyei Oktato Korhaz	Győr		Hungary	9023
60	Pest Megyei Flor Ferenc Korhaz	Kistarcsa		Hungary	2143
61	Barzilai Medical Center	Ashkelon		Israel	7830604
62	Rambam Medical Center	Haifa		Israel	3109601
63	Hadassah Medical Center	Jerusalem		Israel	9112001
64	Ziv Medical Center	Safed		Israel	1304300
65	Ospedale San Salvatore	L' Aquila		Italy	67100
66	Azienda Ospedaliera Sant Andrea	Roma		Italy	189
67	Pauls Stradins Clinical University Hospital	Riga		Latvia	1002
68	Latvias Juras medicinas centrs Ltd	Riga		Latvia	1015
69	Rīgas Austrumu klīniskā universitātes slimnīca	Riga		Latvia	LV-1038
70	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas		Lithuania	LT50161
71	VsI Respublikine Siauliu ligonine, V.	Šiauliai		Lithuania	76231
72	Unidad de Investigacion En Salud	Chihuahua		Mexico	31203
73	CRI Centro Regiomontano de Investigacion SC	Nuevo Leon		Mexico	64060
74	Neurocentrum Bydgoszcz Sp Z O O	Bydgoszcz		Poland	85-796
75	Copernicus Podmiot Leczniczy Sp. z o.o	Gdansk		Poland	80-803
76	NeuroCentrum. Centrum Terapii SM	Katowice		Poland	40-571
77	NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna	Katowice		Poland	40-686
78	Centrum Kompleksowej Rehabilitacji	Konstancin-Jeziorna		Poland	05-510
79	Centrum Opieki Zdrowotnej Orkan-Med	Ksawerow		Poland	95-054
80	Indywidualna Praktyka Lekarska Prof. Konrad Rejdak	Lublin		Poland	20-015
81	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po	Poznan		Poland	60-355
82	NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy	Poznan		Poland	61-853
83	Clinical Research Center sp. z o.o MEDIC-R s.k.	Poznań		Poland	60-848
84	WroMedica I.Bielicka, A.Strzałkowska s.c.	Wrocław		Poland	51-685
85	Hospital de Braga	Braga		Portugal	4710-243
86	Hospitais da universidade de Coimbra	Coimbra		Portugal	3000-075
87	Hosp. Cuf Descobertas	Lisboa		Portugal	1998-018
88	H. Santo António - Centro Hospitalar do Porto	Porto		Portugal	4099-001
89	Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'	Bucuresti		Romania	10825
90	Institutul Clinic Fundeni	Bucuresti		Romania	22328
91	Spitalul Universitar de Urgenta Bucuresti	Bucuresti		Romania	50098
92	Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'	Timisoara		Romania	300723
93	Barnaul Territorial Clinical Hospital	Barnaul, Altai Krai		Russian Federation	656024
94	St. Joseph Belgorod Regional Hospital	Belgorod		Russian Federation	308007
95	Bryansk Regional Hospital #1	Bryansk		Russian Federation	241033
96	Sverdlovsk Region Clinical Hospital #1	Ekaterinburg		Russian Federation	620102
97	Research Medical Center Your Health	Kazan		Russian Federation	420097
98	Federal State Budgetary Institution	Krasnoyarsk		Russian Federation	660037
99	State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital	Kursk		Russian Federation	305007
100	Clinical City Hospital #1	Moscow		Russian Federation	117049
101	State Health Care Institution Of Moscow	Moscow		Russian Federation	127015
102	Central Clinical Hospital N.A.Semashko	Moscow		Russian Federation	129128
103	Municipal Clinical Hospital # 3	Nizhniy Novgorod		Russian Federation	603155
104	Siberian District Medical Center of Federal Medical-Biological Agency	Novosibirsk		Russian Federation	630007
105	Federal Scientific Clinical Center of Physico-Chemical Medicine	Odintsovo		Russian Federation	143000
106	Perm State Medical Academy n.a. E. A. Vagner	Perm		Russian Federation	614990
107	City Clinical Hospital # 2	Pyatigorsk		Russian Federation	357538
108	Pavlov First Saint Petersburg State Medical University	Saint Petersburg		Russian Federation	197022
109	State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin	Samara		Russian Federation	443095
110	Smolensk Regional Clinical Hospital	Smolensk		Russian Federation	214018
111	Municipal Multi-Specialty Hospital # 2	St. Petersburg		Russian Federation	194354
112	City Clinical Hospital #31	St. Petersburg		Russian Federation	197110
113	Institute of Human Brain Ras	St. Petersburg		Russian Federation	197376
114	City Hospital# 40	St.Petersburg		Russian Federation	197706
115	Siberian State Medical University	Tomsk		Russian Federation	634050
116	Tver Regional Clinical Hospital	Tver		Russian Federation	170036
117	GUZ Novgorod Regional Clinical Hospital	Velikiy Novgorod		Russian Federation	214018
118	Yaroslavl Clinical Hospital #8	Yaroslavl		Russian Federation	150003
119	Clinical Hospital Center Zvezdara	Belgrade		Serbia	11000
120	Vojnomedicinska Akademija	Belgrade		Serbia	11000
121	University Clinical Center Kragujevac	Kragujevac		Serbia	34000
122	University Clinical Center NIS	Nis		Serbia	18000
123	Hospital del Mar	Barcelona		Spain	8003
124	Hospital Vall d'Hebron	Barcelona		Spain	8035
125	Hospital Clinic I Provincial	Barcelona		Spain	8036
126	Hospital Universitario de La Princesa	Madrid		Spain	28006
127	Hospital Regional Universitario de Malaga	Malaga		Spain	29010
128	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
129	Hospital Vithas Nisa Sevilla	Sevilla		Spain	41950
130	Sahlgrenska Universitetsjukhuset	Göteborg		Sweden	413 45
131	Centrum för Neurologi	Stockholm		Sweden	113 65
132	Karadeniz Teknik University Medical Faculty	Trabzon		Turkey	61080
133	Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council	Chernihiv		Ukraine	14001
134	Municipal health care institution Chernihiv Regional Hospital	Chernihiv		Ukraine	14029
135	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk		Ukraine	76018
136	Limited Liability Company 'Neuro Global'	Ivano-Frankivsk		Ukraine	76493
137	Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'	Kharkiv		Ukraine	61103
138	Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7	Kharkiv		Ukraine	61176
139	National Research Center for Radiation Medicine	Kyiv		Ukraine	3115
140	Public Non-Profit Enterprise: Lviv City Clinical Hospital #5	Lviv		Ukraine	79000
141	Lviv Clinical Regional Hospital	Lviv		Ukraine	79010
142	Odessa National Medical University	Odesa		Ukraine	65009
143	ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'	Poltava		Ukraine	36024
144	Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb	Ternopil		Ukraine	46027
145	Public Institution Vinnitsa O.I. Yuschenko Regional Neuropsychiatric Hospital	Vinnytsia		Ukraine	21005
146	O.F. Herbachevskyi Regional Clinical Hospital	Zhytomyr		Ukraine	10008
147	Royal Preston Hospital	Preston		United Kingdom	PR2 9HT
148	Salford Royal NHS Foundation Trust	Salford		United Kingdom	M6 8HD

Sponsors and Collaborators

• Actelion

Investigators

• Study Director: Tatiana Sidorenko, MD, PhD, Actelion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Actelion
• ClinicalTrials.gov Identifier: NCT03232073
• Other Study ID Numbers: AC-058B303; 2016-004719-10
• First Posted: Jul 27, 2017
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Ponesimod

Study Results

No Results Posted as of Aug 17, 2022