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Sphingosine-1-phosphate receptor modulator

Ponesimod 10 mg for Multiple Sclerosis

Phase 2
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from ponesimod baseline up to the end of analysis period (ap) 3. the actual time varied for each participant and could be up to 13.3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the long-term effects of ponesimod, a drug used to treat relapsing-remitting multiple sclerosis.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from ponesimod baseline up to the end of analysis period (ap) 3. the actual time varied for each participant and could be up to 13.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from ponesimod baseline up to the end of analysis period (ap) 3. the actual time varied for each participant and could be up to 13.3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized Relapse Rate (ARR) of Confirmed Relapses
Time to 24 Weeks Confirmed Disability Progression
Time to First Confirmed Relapse
Other study objectives
Number of Participants With at Least One Treatment-emergent Serious Adverse Events (SAEs)

Side effects data

From 2023 Phase 2 trial • 353 Patients • NCT01093326
32%
Nasopharyngitis
21%
Headache
19%
Upper Respiratory Tract Infection
16%
Back Pain
15%
Bronchitis
14%
Urinary Tract Infection
13%
Hypertension
13%
Alanine Aminotransferase Increased
13%
Covid-19
12%
Fatigue
12%
Influenza
11%
Arthralgia
11%
Hypercholesterolaemia
10%
Dizziness
10%
Pain in Extremity
9%
Cough
8%
Diarrhoea
8%
Obstructive Airways Disorder
8%
Sinusitis
8%
Rhinitis
8%
Respiratory Tract Infection
8%
Forced Expiratory Volume Decreased
8%
Depression
8%
Insomnia
8%
Oropharyngeal Pain
7%
Gastroenteritis
7%
Anaemia
7%
Aspartate Aminotransferase Increased
7%
Ligament Sprain
7%
Dyspnoea
6%
Gastroenteritis Viral
6%
Rash
6%
Cystitis
6%
Pyrexia
6%
Melanocytic Naevus
6%
Constipation
6%
Herpes Zoster
6%
Viral Infection
6%
Migraine
6%
Toothache
6%
Hyperlipidaemia
6%
Oedema Peripheral
6%
Contusion
6%
Anxiety
5%
Nausea
5%
Vertigo
5%
Paraesthesia
4%
Lymphopenia
4%
Oral Herpes
4%
Tonsillitis
3%
Muscle Spasms
3%
Pharyngitis
3%
Vomiting
3%
Abdominal Pain Upper
3%
Multiple Sclerosis
3%
Asthma
3%
Blood Cholesterol Increased
2%
Conjunctivitis
2%
Eye Pain
2%
Forced Vital Capacity Decreased
1%
Road Traffic Accident
1%
Magnetic Resonance Imaging Abnormal
1%
Papilloedema
1%
Uterine Polyp
1%
Mitral Valve Prolapse
1%
Acute Stress Disorder
1%
Varicose Vein
1%
Non-Cardiac Chest Pain
1%
Cervicitis
1%
Chronic Hepatitis C
1%
Macular Oedema
1%
Duodenal Ulcer Haemorrhage
1%
Haemorrhoids
1%
Sudden Death
1%
Hepatosplenomegaly
1%
Microcytic Anaemia
1%
Atrioventricular Block Second Degree
1%
Myocardial Infarction
1%
Chest Injury
1%
Lumbar Spinal Stenosis
1%
Cervical Radiculopathy
1%
Uterine Haemorrhage
1%
Appendicectomy
1%
Transient Ischaemic Attack
1%
Pulmonary Function Test Decreased
1%
Intermenstrual Bleeding
1%
Ovarian Cyst
1%
Hypertensive Crisis
1%
Breast Cancer
1%
Complicated Appendicitis
1%
Intraductal Papilloma of Breast
1%
Pulmonary Embolism
1%
Diverticulitis
1%
Benign Hydatidiform Mole
1%
Endometrial Hyperplasia
1%
Basal Cell Carcinoma
1%
Bowen's Disease
1%
Invasive Ductal Breast Carcinoma
1%
Type 2 Diabetes Mellitus
1%
Cholelithiasis
1%
Uterine Leiomyoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ponesimod 20 Milligrams (mg)
Ponesimod 40 Milligrams (mg)
Ponesimod 10 Milligrams (mg)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ponesimod 40 mgExperimental Treatment1 Intervention
Ponesimod 40 mg oral use
Group II: Ponesimod 20 mgExperimental Treatment1 Intervention
Ponesimod 20 mg oral use
Group III: Ponesimod 10 mgExperimental Treatment1 Intervention
Ponesimod 10 mg oral use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ponesimod 40 mg
2011
Completed Phase 2
~470
Ponesimod 10 mg
2011
Completed Phase 2
~470
Ponesimod 20 mg
2011
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,176 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
2,610 Patients Enrolled for Multiple Sclerosis

Media Library

Ponesimod 10 mg (Sphingosine-1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT01093326 — Phase 2
Multiple Sclerosis Research Study Groups: Ponesimod 10 mg, Ponesimod 40 mg, Ponesimod 20 mg
Multiple Sclerosis Clinical Trial 2023: Ponesimod 10 mg Highlights & Side Effects. Trial Name: NCT01093326 — Phase 2
Ponesimod 10 mg (Sphingosine-1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01093326 — Phase 2
~23 spots leftby Nov 2025
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