Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
- Conditions
- Plantar FibromatosisLedderhose Disease
- Interventions
- Other: Placebo
- Registration Number
- NCT06151197
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 418
- Be an ambulatory male or female ≥18 years of age.
- Have a diagnosis of PFI.
- Have current foot pain due to PFI.
- Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
- If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
- Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.
Key
- Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
- Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
- Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
- Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
- Has a clinically significant laboratory abnormality.
- Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
- Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Is pregnant or plans to become pregnant.
- Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - EN3835 EN3835 -
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Nodular Hardness of the Treated Nodules Up to Day 85 Change from Baseline in the FFI Total Score Baseline, up to Day 85 Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score Baseline, up to Day 85 Change from Baseline in the FFI Activity Limitation Subscale Score Baseline, up to Day 85 Change from Baseline in the FFI Pain Subscale Score Baseline, up to Day 85 Number of Participants That Used Rescue Analgesic Medication Up to Day 85 Amount of (milligrams [mg]) Rescue Analgesic Medication Used Up to Day 85 Patient Global Impression of Change (PGIC) Foot Pain Score Up to Day 85 Clinician Global Impression of Change (CGIC) Score Up to Day 85 Subject Satisfaction Score Up to Day 85 Change from Baseline in Nodule Consistency (Firmness) Baseline, up to Day 85
Trial Locations
- Locations (70)
Endo Site 42
🇺🇸Mesa, Arizona, United States
Endo Site 64
🇺🇸Scottsdale, Arizona, United States
Endo Site 11
🇺🇸Tucson, Arizona, United States
Endo Site 49
🇺🇸Castro Valley, California, United States
Endo Site 39
🇺🇸Cerritos, California, United States
Endo Site 31
🇺🇸Corona, California, United States
Endo Clinical Site 2
🇺🇸Encinitas, California, United States
Endo Site 8
🇺🇸Fresno, California, United States
Endo Site 28
🇺🇸Lancaster, California, United States
Endo Site 9
🇺🇸Los Angeles, California, United States
Endo Site 53
🇺🇸Los Angeles, California, United States
Endo Site 50
🇺🇸San Francisco, California, United States
Endo Site 29
🇺🇸Tarzana, California, United States
Endo Site 30
🇺🇸Tarzana, California, United States
Endo Site 61
🇺🇸Torrance, California, United States
Endo Site 47
🇺🇸Johnstown, Colorado, United States
Endo Site 65
🇺🇸Parker, Colorado, United States
Endo Site 17
🇺🇸Westminster, Colorado, United States
Endo Site 52
🇺🇸Washington, District of Columbia, United States
Endo Site 22
🇺🇸Hialeah, Florida, United States
Endo Site 59
🇺🇸Jacksonville, Florida, United States
Endo Site 19
🇺🇸Jupiter, Florida, United States
Endo Site 33
🇺🇸Medley, Florida, United States
Endo Site 23
🇺🇸Miami, Florida, United States
Endo Site 21
🇺🇸Miami, Florida, United States
Endo Site 35
🇺🇸North Miami Beach, Florida, United States
Endo Clinical Site 1
🇺🇸Pinellas Park, Florida, United States
Endo Site 14
🇺🇸Plantation, Florida, United States
Endo Site 26
🇺🇸South Miami, Florida, United States
Endo Site 60
🇺🇸Sweetwater, Florida, United States
Endo Site 24
🇺🇸Lawrenceville, Georgia, United States
Endo Site 27
🇺🇸O'Fallon, Illinois, United States
Endo Site 45
🇺🇸Oak Brook, Illinois, United States
Endo Site 54
🇺🇸Overland Park, Kansas, United States
Endo Site 56
🇺🇸Shreveport, Louisiana, United States
Endo Site 5
🇺🇸Pasadena, Maryland, United States
Endo Site 16
🇺🇸Grand Rapids, Michigan, United States
Endo Site 12
🇺🇸Jefferson City, Missouri, United States
Endo Site 51
🇺🇸Billings, Montana, United States
Endo Site 36
🇺🇸Missoula, Montana, United States
Endo Site 62
🇺🇸Vineland, New Jersey, United States
Endo Site 34
🇺🇸Westwood, New Jersey, United States
Endo Site 15
🇺🇸Durham, North Carolina, United States
Endo Site 20
🇺🇸Wilmington, North Carolina, United States
Endo Site 63
🇺🇸Oklahoma City, Oklahoma, United States
Endo Site 10
🇺🇸Altoona, Pennsylvania, United States
Endo Site 44
🇺🇸Malvern, Pennsylvania, United States
Endo Site 38
🇺🇸State College, Pennsylvania, United States
Endo Site 48
🇺🇸Arlington, Texas, United States
Endo Site 3
🇺🇸Bedford, Texas, United States
Endo Site 43
🇺🇸Burleson, Texas, United States
Endo Site 25
🇺🇸Dallas, Texas, United States
Endo Site32
🇺🇸Fort Worth, Texas, United States
Endo Site 7
🇺🇸Georgetown, Texas, United States
Endo Site 40
🇺🇸Humble, Texas, United States
Endo Site 4
🇺🇸McAllen, Texas, United States
Endo Site 55
🇺🇸Houston, Texas, United States
Endo Site 46
🇺🇸San Antonio, Texas, United States
Endo Site 18
🇺🇸San Antonio, Texas, United States
Endo Site 37
🇺🇸San Antonio, Texas, United States
Endo Site 41
🇺🇸Bountiful, Utah, United States
Endo Site 6
🇺🇸Salt Lake City, Utah, United States
Endo Site 13
🇺🇸Suffolk, Virginia, United States
Endo Site 58
🇦🇺East Maitland, New South Wales, Australia
Endo Site 57
🇦🇺Hunter, New South Wales, Australia
Endo Site 67
🇦🇺Auchenflower, Queensland, Australia
Endo Site 66
🇦🇺Victoria Park, Western Australia, Australia
Endo Site 68
🇵🇷Mayagüez, Puerto Rico
Endo Site 70
🇵🇷Mayagüez, Puerto Rico
Endo Site 69
🇵🇷Ponce, Puerto Rico