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Sphingosine-1-phosphate receptor modulator

Ponesimod for Relapsing Multiple Sclerosis (OPTIMUM-LT Trial)

Phase 3
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

OPTIMUM-LT Trial Summary

This trial will study the long-term effects of a drug called ponesimod in people with relapsing multiple sclerosis.

Who is the study for?
This trial is for people with relapsing multiple sclerosis who finished the main study AC-058B301. They must understand and agree to the study's rules, including regular pregnancy tests and using reliable birth control. People can't join if they have a slow heart rate, certain heart blocks or long QTcF interval, unresolved breathing issues, are pregnant or breastfeeding, have had macular edema recently, plan to father a child soon, or have other health risks as judged by the investigator.Check my eligibility
What is being tested?
The trial is testing Ponesimod 20 mg over a long period to see how safe it is and how well it controls relapsing multiple sclerosis after initial positive results in an earlier phase of research.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include those commonly associated with MS treatments such as flu-like symptoms, injection site reactions, liver problems; plus specific concerns from previous studies like slowed heart rate or breathing issues.

OPTIMUM-LT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absence of MRI lesions
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
Absolute values and percent change from baseline in forced expiratory volume and forced vital capacity
+20 more

Side effects data

From 2019 Phase 3 trial • 1133 Patients • NCT02425644
17%
Nasopharyngitis
13%
Headache
13%
Alopecia
10%
Upper Respiratory Tract Infection
9%
Alanine Aminotransferase Increased
8%
Nausea
8%
Diarrhoea
8%
Hypertension
7%
Back Pain
7%
Fatigue
5%
Paraesthesia
5%
Depression
5%
Urinary Tract Infection
4%
Oral Herpes
4%
Constipation
4%
Abdominal Pain Upper
4%
Bronchitis
4%
Influenza
3%
Dizziness
3%
Pain in Extremity
3%
Sinusitis
3%
Aspartate Aminotransferase Increased
3%
Gastroenteritis
3%
Insomnia
3%
Rhinitis
3%
Anxiety
3%
Abdominal Pain
3%
Vomiting
3%
Asthenia
3%
Arthralgia
3%
Respiratory Tract Infection
2%
Pharyngitis
2%
Hypoaesthesia
2%
Neutropenia
2%
Respiratory Tract Infection Viral
2%
Somnolence
2%
Tonsillitis
2%
Weight Decreased
2%
Rash
2%
Dyspepsia
2%
Cough
1%
Hepatic Enzyme Increased
1%
Vertigo
1%
C-Reactive Protein Increased
1%
Dyspnoea
1%
Pyrexia
1%
Hypercholesterolaemia
1%
Cholelithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriflunomide 14 mg
Ponesimod 20 mg

OPTIMUM-LT Trial Design

1Treatment groups
Experimental Treatment
Group I: PonesimodExperimental Treatment1 Intervention
20 mg administered orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ponesimod
2022
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
34,816 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
2,086 Patients Enrolled for Multiple Sclerosis
Tatiana Sidorenko, MD, PhDStudy DirectorActelion
Tatiana Scherz, MD, PhDStudy DirectorActelion
2 Previous Clinical Trials
1,269 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
1,269 Patients Enrolled for Multiple Sclerosis

Media Library

Ponesimod (Sphingosine-1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03232073 — Phase 3
Multiple Sclerosis Research Study Groups: Ponesimod
Multiple Sclerosis Clinical Trial 2023: Ponesimod Highlights & Side Effects. Trial Name: NCT03232073 — Phase 3
Ponesimod (Sphingosine-1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03232073 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When might Ponesimod be available commercially?

"Ponesimod has reached Phase 3 in clinical trials, so there is some data suggesting that it is effective and multiple rounds of data that support its safety. Therefore, our team at Power has given it a safety rating of 3."

Answered by AI

What other scientific research has there been on Ponesimod?

"Currently, there are three ongoing clinical trials researching Ponesimod. One of these trials is in Phase 3 and the others are in earlier stages. While the majority of these trials are based in Chernihiv, Florida, there are a total of 252 locations running trials for this treatment across the world."

Answered by AI

Is recruitment for this research still taking place?

"The clinical trial in question is no longer recruiting patients, as indicated by data from clinicaltrials.gov. This particular trial was first posted on July 5th, 2017, and was last updated on October 11th, 2022. However, there are 561 other trials that are currently recruiting patients."

Answered by AI

Can you name all of the places where this trial is taking place?

"The trial is being conducted at 14 total sites, with the primary locations being Ohio Health in Columbus, Ohio; Josephson Wallack Munshower Neurology, PC in Indianapolis, Indiana; and Advanced Neurosciences Institute in Franklin, Tennessee."

Answered by AI

Who meets the standards to be selected for this clinical trial?

"The investigators of this study are looking for around 869 individuals who have a diagnosis of multiple sclerosis and are aged 18-65."

Answered by AI

Could you tell me how many people are involved in this research project?

"This study has completed recruitment for participants. The study was posted on July 5th, 2017, and was last edited on October 11th, 2022. However, there are 558 other studies for patients with multiple sclerosis and 3 trials for Ponesimod that are actively recruiting patients."

Answered by AI

Is this the initial study of its protocol?

"Ponesimod has undergone 10 clinical trials, the first of which was completed in 2010. The most recent trials are still active and taking place in 52 cities across 31 countries."

Answered by AI

Are people of all ages welcome to enroll in this research?

"According to the information available, people who want to participate in this clinical trial must be between 18 and 65 years old. There are currently 42 studies ongoing for patients that are under 18 and 404 for patients that are over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
2017. "Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03232073.
~113 spots leftby Apr 2025
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