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Retinoic Acid Receptor Agonist

Palovarotene for Stone Man Syndrome (MOVE Trial)

Phase 3
Waitlist Available
Research Sponsored by Clementia Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Abstinent or using two highly effective forms of birth control.
Written, signed, and dated informed subject/parent consent; and for subjects who are minors, age-appropriate assent (performed according to local regulations).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, every 6 months up to 4 years
Awards & highlights

MOVE Trial Summary

This trial is for a drug to treat Fibrodysplasia Ossificans Progressiva, which is a rare disease that causes bones to form in muscles and connective tissue, leading to loss of movement and disability.

Eligible Conditions
  • Stone Man Syndrome

MOVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MOVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, every 6 months up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, every 6 months up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized New Heterotopic Ossification (HO)
Secondary outcome measures
Number of Body Regions With New HO
Percentage of Participants With Any New HO
Percentage of Participants With Flare-Ups
+1 more
Other outcome measures
FOP-Physical Function Questionnaire
PROMIS Global Health Scale
Range of Motion

Side effects data

From 2022 Phase 3 trial • 107 Patients • NCT03312634
46%
Dry skin
32%
Drug eruption
26%
Alopecia
21%
Lip Dry
20%
Erythema
19%
Arthralgia
17%
Pruritus
14%
Pruritus generalised
14%
Pruritus generalized
14%
Rash
14%
Skin exfoliation
14%
Dry Eye
12%
Chapped Lips
12%
Paronychia
12%
Epiphyses Premature Fusion
11%
Nasopharyngitis
11%
Skin Abrasion
11%
Pain In Extremity
10%
Cheilitis
9%
Dermatitis
9%
Fall
9%
Headache
7%
Peripheral swelling
7%
Ear Infection
7%
Upper Respiratory Tract Infection
7%
Neck Pain
7%
Contusion
6%
Bone density decreased
6%
Decreased Appetite
6%
Alanine aminotransferase increased
6%
Skin irritation
6%
Rash maculo-papular
6%
Vomiting
6%
Musculoskeletal Pain
6%
Cough
6%
Bronchitis
5%
Influenza
5%
Ingrowing nail
5%
Rash generalized
4%
Decubitus Ulcer
4%
Joint range of motion decreased
4%
Condition Aggravated
4%
Otitis Media
4%
Abdominal Pain
4%
Back Pain
4%
Epistaxis
4%
Hypoacusis
4%
Pain In Jaw
4%
Peripheral Swelling
4%
Nausea
4%
Groin Pain
4%
Fatigue
3%
Ocular Hyperemia
3%
Rash Pruritic
3%
Oropharyngeal Pain
3%
Nasal Dryness
3%
Alanine Aminotransferase Increased
3%
Gamma-Glutamyltransferase Increased
3%
Abnormal Dreams
3%
Depressed Mood
3%
Eczema
2%
Corona virus infection
2%
Pain in jaw
2%
Myalgia
2%
Diarrhea
2%
Gastroenteritis
1%
Ear pain
1%
Ear Pain
1%
Cellulitis
1%
Escherichia Sepsis
1%
Mycoplasma Infection
1%
Urosepsis
1%
Malnutrition
1%
Anemia
1%
Pharyngitis
1%
Skin Disorder
1%
Skin Plaque
1%
Swelling Face
1%
Back Injury
1%
Extraskeletal Ossification
1%
Musculoskeletal Stiffness
1%
Dizziness
1%
Ear Discomfort
1%
Non-Cardiac Chest Pain
1%
Pain
1%
Blood Alkaline Phosphatase Increased
1%
Insomnia
1%
Mobility Decreased
1%
Pneumonia
1%
Urinary Tract Infection
1%
Traumatic Fracture
1%
Abnormal Loss Of Weight
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palovarotene 20/10 mg
Untreated (PVO-1A-001)
Flare-Up Treatment: Supplemental SS
Untreated (PVO-1A-001)
Palovarotene 5 mg

MOVE Trial Design

1Treatment groups
Experimental Treatment
Group I: Palovarotene Chronic/Flare-Up RegimenExperimental Treatment1 Intervention
Participants received 5 mg palovarotene once daily for up to 48 months; and 20 mg palovarotene once daily for 28 days, followed by 10 mg for 56 days for flareups. (Dosing was adjusted for weight in skeletally immature subjects.)
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?

Clementia Pharmaceuticals Inc.Lead Sponsor
10 Previous Clinical Trials
628 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
251 Previous Clinical Trials
54,309 Total Patients Enrolled

Frequently Asked Questions

~15 spots leftby Mar 2025