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Retinoic Acid Receptor Agonist
Palovarotene for Stone Man Syndrome (PIVOINE Trial)
Phase 3
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be ≥14 years of age (aligned with the age of treated participants in the ongoing parent studies PVO-1A-301 and PVO-1A-202/PVO-1A-204) and qualify as 100% skeletally mature (if <18 years, based on assessments carried out at parent EOS Visit; if ≥18 years, automatically considered 100% skeletally mature) or have reached final adult height based on investigator's assessment, at the time the Study CLIN- 60120-452 informed consent is signed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years.
Awards & highlights
PIVOINE Trial Summary
This trial is looking at the safety and effectiveness of a drug called palovarotene in people with a condition called fibrodysplasia ossificans progressiva (FOP). The trial is also for people who have completed one of the previous studies on this drug and may still benefit from it.
Who is the study for?
This trial is for males and females aged 14 or older with Fibrodysplasia Ossificans Progressiva (FOP) who have finished previous related studies. Participants under 18 must be fully skeletally mature, while those over 18 are presumed so. They should not have any conditions that could risk their safety or affect the study.Check my eligibility
What is being tested?
The trial is testing the continued use of Palovarotene capsules to assess its long-term safety and effectiveness in treating FOP. It's designed for patients from prior parent studies who might benefit from ongoing treatment.See study design
What are the potential side effects?
Palovarotene may cause side effects such as dry skin, eye problems like conjunctivitis, headaches, joint pain, hair loss, and possibly liver issues indicated by elevated enzyme levels.
PIVOINE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 14 or older and my bones have fully grown.
PIVOINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and description of all serious and non-serious treatment-emergent adverse events (TEAEs) whether or not they are considered as related to the study intervention;
Secondary outcome measures
Frequency of healthcare services utilization
Percentage of participants with new bone growth overall and by flare-up status
Raw values and change from the Inclusion Visit in % of worst score for total score, upper extremities subscore and mobility subscore
+8 moreSide effects data
From 2022 Phase 3 trial • 107 Patients • NCT0331263450%
Dry skin
50%
Alopecia
50%
Pruritus
50%
Dry Eye
50%
Rash
25%
Paronychia
25%
Hypoacusis
25%
Condition Aggravated
25%
Anemia
25%
Erythema
25%
Skin exfoliation
25%
Skin irritation
25%
Chapped Lips
25%
Nasopharyngitis
25%
Musculoskeletal Pain
25%
Skin Abrasion
25%
Headache
25%
Skin Fissures
25%
Skin Disorder
25%
Skin Burning Sensation
25%
Hypotrichosis
25%
Swelling Face
25%
Musculoskeletal Stiffness
25%
Dizziness
25%
Hyperesthesia
25%
Oropharyngeal Pain
25%
Tinnitus
25%
Pain
25%
Visual Impairment
25%
Ocular Hyperemia
25%
Alanine Aminotransferase Increased
25%
Blood Alkaline Phosphatase Increased
25%
Nausea
25%
Breast Cyst
25%
Pruritus generalized
25%
Gamma-Glutamyltransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Flare-Up Treatment: Supplemental SS
Untreated (PVO-1A-001)
Palovarotene 20/10 mg
Untreated (PVO-1A-001)
Palovarotene 5 mg
PIVOINE Trial Design
1Treatment groups
Experimental Treatment
Group I: Palovarotene Chronic/Flare-Up RegimenExperimental Treatment1 Intervention
Chronic treatment: participants will receive 5 mg palovarotene or the dose received during participation in the parent study at the time of transition to Study CLIN-60120-452 or prior to interrupting/stopping palovarotene treatment.
Flare-up treatment: at the time of a flare-up (or substantial high-risk traumatic event likely to lead to a flare-up) participants will receive 20 mg palovarotene for 28 days, followed by 10 mg palovarotene for 56 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palovarotene
2014
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
IpsenLead Sponsor
345 Previous Clinical Trials
73,167 Total Patients Enrolled
Ipsen DirectorStudy DirectorIpsen
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
55,084 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a painful broken bone in my spine.I am not taking drugs that strongly affect liver enzyme CYP450 3A4 or drugs like imatinib.I am allergic to retinoids, gelatin, lactose, or palovarotene, or palovarotene didn't work for me.I do not have any broken bones that are currently healing.Palovarotene is covered by insurance in my country.I am 14 or older and my bones have fully grown.My amylase or lipase levels are more than twice the normal limit, or I have chronic pancreatitis.I haven't taken any synthetic oral retinoids except palovarotene in the last 4 weeks.I am not taking vitamin A, beta carotene, multivitamins, herbal preparations, or fish oil, or I am willing to stop during treatment.My fasting triglycerides are over 400 mg/dL, even with treatment.I do not have any uncontrolled major health issues.I am not taking tetracycline or similar medications due to risk of a rare brain condition.
Research Study Groups:
This trial has the following groups:- Group 1: Palovarotene Chronic/Flare-Up Regimen
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Palovarotene been accepted by the FDA?
"Palovarotene safety is rated highly by our team at Power. A score of 3 was given because this is a Phase 3 trial, which suggests that not only is there some evidence of efficacy, but multiple rounds of data support the safety of the medication."
Answered by AI
Is this a study that is breaking new ground?
"Palovarotene was first studied in 2022 by the pharmaceutical company Ipsen. The study, which involved 87 people, was followed by Phase 3 approval. As of now, Ipsen is the only sponsor of an active study on Palovarotene."
Answered by AI
Are there any other examples of Palovarotene being used in research?
"1 clinical trial is currently underway to research Palovarotene. The active trial is in its third phase. Although the majority of trials for Palovarotene are based in Genoa, New South Wales, there are a total of 10 locations running these studies."
Answered by AI
Are we able to include more people in this experiment?
"That is correct. According to the information available on clinicaltrials.gov, this trial is still enrolling patients. The trial was originally posted on March 14th, 2022 and was edited on October 26th, 2022. There is space for 87 patients at the single location."
Answered by AI
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