| 1 |
NCT02745158 |
Recruiting |
The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry |
- Fibrodysplasia Ossificans Progressiva (FOP)
|
|
Observational
|
|
- The International FOP Association
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Patient Reported Changes in New Bone Growth Using a Patient-Directed Survey Developed by the IFOPA
- Patient Reported Changes in Episodic Flare-Ups Using a Patient-Directed Survey Developed by the IFOPA
- Patient Reported Changes in Mobility Using a Patient-Directed Survey Developed by the IFOPA
- (and 9 more...)
|
800 |
All |
Child, Adult, Older Adult |
NCT02745158 |
IFOPA-REG-001 |
|
July 2015 |
July 2025 |
December 2025 |
April 20, 2016 |
August 17, 2017 |
|
- The International FOP Association
Casselberry, Florida, United States
|
|
| 2 |
NCT02322255 |
Active, not recruiting |
A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP) |
- Fibrodysplasia Ossificans Progressiva
|
|
Observational
|
|
- Clementia Pharmaceuticals Inc.
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Change from baseline in the total body burden of heterotopic ossification as assessed by the optimal imaging modality (low-dose whole body CT [excluding head]).
- Change from baseline in physical function as assessed by range of motion.
- Change from baseline in patient-reported use of assistive devices and adaptations.
- (and 9 more...)
|
100 |
All |
up to 65 Years (Child, Adult, Older Adult) |
NCT02322255 |
PVO-1A-001 |
|
December 2014 |
October 2019 |
October 2019 |
December 23, 2014 |
August 1, 2019 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - University of Pennsylvania, Center for FOP & Related Bone Disorders
Philadelphia, Pennsylvania, United States - Hospital Italiano de Buenos Aires, Department of Pediatrics
Buenos Aires, Argentina - (and 4 more...)
|
|
| 3 |
NCT03312634 |
Active, not recruiting |
An Efficacy and Safety Study of Palovarotene for the Treatment of FOP |
- Fibrodysplasia Ossificans Progressiva
|
|
Interventional
|
Phase 3 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in New HO Volume
- Subjects with New HO
- Number of Body Regions with HO
- (and 4 more...)
|
90 |
All |
4 Years and older (Child, Adult, Older Adult) |
NCT03312634 |
PVO-1A-301 |
|
November 28, 2017 |
September 2020 |
November 2020 |
October 18, 2017 |
January 30, 2019 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - Mayo Clinic - 200 1st Street Southwest
Rochester, Minnesota, United States - Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States - (and 12 more...)
|
|
| 4 |
NCT02279095 |
Active, not recruiting |
An Open-Label Extension Study of Palovarotene Treatment in FOP |
- Fibrodysplasia Ossificans Progressiva
|
- Drug: Palovarotene dose level 1
- Drug: Palovarotene dose level 2
- Drug: Palovarotene dose level 3
- Drug: Palovarotene dose level 4
|
Interventional
|
Phase 2 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in New HO Volume
- Subjects with New HO
- Range of Motion
- (and 4 more...)
|
58 |
All |
6 Years to 65 Years (Child, Adult, Older Adult) |
NCT02279095 |
PVO-1A-202 |
|
October 2014 |
March 2021 |
March 2021 |
October 30, 2014 |
January 30, 2019 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - Mayo Clinic, Department of Medicine
Rochester, Minnesota, United States - University of Pennsylvania, Center for FOP & Related Bone Disorders
Philadelphia, Pennsylvania, United States - (and 4 more...)
|
|
| 5 |
NCT02979769 |
Active, not recruiting |
An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in France |
- Fibrodysplasia Ossificans Progressiva
|
- Drug: Palovarotene dose level 1
- Drug: Palovarotene dose level 2
|
Interventional
|
Phase 2 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of flare-ups with no new HO as assessed by low-dose CT scan
- Amount (volume) of new HO at the flare-up site as assessed by low-dose CT scan.
- Amount (volume) of new HO overall as assessed by low-dose whole body CT scan, excluding head.
- (and 13 more...)
|
17 |
All |
6 Years to 65 Years (Child, Adult, Older Adult) |
NCT02979769 |
PVO-1A-204 |
|
November 2016 |
March 2021 |
March 2021 |
December 2, 2016 |
January 30, 2019 |
|
- Hôpital Necker-Enfants Malades, Department of Genetics
Paris, France
|
|
| 6 |
NCT02521792 |
Suspended |
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects |
- Fibrodysplasia Ossificans Progressiva
|
|
Interventional
|
Phase 2 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of palovarotene as assessed by the incidence of treatment-emergent adverse events (including those known to be associated with retinoids) and serious adverse events monitored throughout the treatment period.
- Global assessment of movement by category as determined by a subject/proxy completed questionnaire
- Change from baseline in Cumulative Analogue Joint Involvement Scale (CAJIS) for FOP
- (and 8 more...)
|
40 |
All |
6 Years to 65 Years (Child, Adult, Older Adult) |
NCT02521792 |
PVO-1A-203 |
|
January 2016 |
June 2019 |
December 2019 |
August 13, 2015 |
January 31, 2019 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - University of Pennsylvania, Center for Research in FOP & Related Disorders
Philadelphia, Pennsylvania, United States - Hôpital Necker-Enfants Malades, Department of Genetics
Paris, France - The Royal National Orthopaedic Hospital, Brockley Hill
Stanmore, Middlesex, United Kingdom
|
|
| 7 |
NCT02190747 |
Completed |
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects |
- Fibrodysplasia Ossificans Progressiva
|
- Drug: Palovarotene
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percentage of subject responders as assessed by plain radiographs.
- Numeric heterotopic ossification scores at the flare-up site as assessed by plain radiograph.
- Amount (area) of new heterotopic bone formed at the flare-up site assessed by plain radiographs.
- (and 10 more...)
|
40 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT02190747 |
PVO-1A-201 |
|
July 2014 |
May 23, 2016 |
May 23, 2016 |
July 15, 2014 |
October 23, 2017 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - University of Pennsylvania, Center for Research in FOP & Related Disorders
Philadelphia, Pennsylvania, United States - Hôpital Necker-Enfants Malades, Department of Genetics
Paris, France - The Royal National Orthopaedic Hospital, Brockley Hill
Stanmore, Middlesex, United Kingdom
|
|
| 8 |
NCT02066324 |
Completed |
Urine Sample Collection From FOP Patients |
- Fibrodysplasia Ossificans Progressiva
|
|
Observational
|
|
- Novartis Pharmaceuticals
- Novartis
|
Industry |
|
- Analysis of pre-defined biomarker FGF2
- Analysis of pre-defined biomarker WEGF
- Analysis of microRNAs
|
25 |
All |
5 Years to 35 Years (Child, Adult) |
NCT02066324 |
CPJMR0062203 |
FOP |
November 2013 |
August 2014 |
August 2014 |
February 19, 2014 |
March 12, 2015 |
|
- Novartis Investigative Site
Philadelphia, Pennsylvania, United States
|
|
| 9 |
NCT03188666 |
Active, not recruiting |
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva |
- Fibrodysplasia Ossificans Progressiva
|
- Drug: REGN2477
- Drug: Matching placebo
|
Interventional
|
Phase 2 |
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence and severity of treatment-emergent adverse events (TEAEs) through the end of the Period 1
- Time-weighted average (standardized area under the curve [AUC]) of the percent change from baseline in total lesion activity by 18F-NaF positron emission tomography (PET) using Baseline-Active HO Classic Mutation (AHOC)
- Percent change from baseline in the total volume of HO lesions as assessed by computed tomography (CT) using AHOC
- (and 32 more...)
|
44 |
All |
18 Years to 60 Years (Adult) |
NCT03188666 |
R2477-FOP-1623
2016-005035-33 |
LUMINA-1 |
February 26, 2018 |
September 16, 2019 |
August 17, 2020 |
June 15, 2017 |
April 15, 2019 |
|
- Mayo Clinic
Rochester, Minnesota, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States - Vanderbilt University
Nashville, Tennessee, United States - (and 4 more...)
|
|
| 10 |
NCT03336151 |
Completed |
FOP Nutrition Label in Campus Cafeteria |
|
- Behavioral: Front-of-pack labelling Nutri-Score
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Overall nutritional quality of purchases
- Energy content of purchases
- Saturated fat content of purchases
- (and 4 more...)
|
119219 |
All |
Child, Adult, Older Adult |
NCT03336151 |
CROUS_NICE2C |
|
September 8, 2017 |
June 8, 2018 |
June 8, 2018 |
November 8, 2017 |
June 13, 2019 |
|
- CROUS Nice - Toulon
Nice, France
|
|
| 11 |
NCT03336164 |
Recruiting |
FOP Nutrition Label in Campus Campus University Restaurant |
|
- Behavioral: Front-of-pack labelling Nutri-Score
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Overall nutritional quality of purchases
- Energy content of purchases
- Saturated fat content of purchases
- (and 4 more...)
|
1000 |
All |
Child, Adult, Older Adult |
NCT03336164 |
CROUS_NICE2R |
|
November 6, 2017 |
July 2018 |
July 2018 |
November 8, 2017 |
May 7, 2018 |
|
- CROUS Nice - Toulon
Nice, France
|
|
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