Peyronie's DiseasePhase 4NCT03767452
Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response
A Phase 4 study testing Xiaflex® 0.58 mg in people with Peyronie's Disease, run by Manhattan Medical Research Practice, PLLC at 1 site in United States.
Trial summary
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- Xiaflex® 0.58 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent to participate in the study.
- Male aged ≥18 years old at screening.
- Previously received Xiaflex® treatment and had a partial or complete response.
- Partial response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of ≥ 15 degrees and < 90 degrees.
- Complete response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of < 15 degrees.
- Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
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- Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral plane at the screening visit. It must be possible to delineate the single plane of maximal curvature for evaluation during the study.
- Able and willing to comply with restrictions where intercourse or any other sexual activity is prohibited during each treatment cycle and for at least 2 weeks after each injection cycle.
- Able and willing to perform home modeling sessions between injection cycles.
- Is in good health based on medical history evaluation and in the judgment of the principal investigator.
Who cannot join
- Has a penile curvature of < 30 degrees or > 90 degrees at the screening visit.
- Previous allergic reaction to XIAFLEX®.
- Has any of the following conditions:
- Chordee in the presence or absence of hypospadias
- Thrombosis of the dorsal penile artery and or vein
- Infiltration by a benign or malignant mass resulting in penile curvature
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- Infiltration by an infectious agent, such as lymphogranuloma venereum
- Ventral curvature from any cause
- Presence of an active sexually transmitted disease
- Known active hepatitis B or C
- Known human immune deficiency virus (HIV)
- Has previously undergone surgery for Peyronie's disease.
- Has an erection which, in the opinion of the investigator, is insufficient to accurately measure the subject's penile deformity after administration of the prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.
- Has a calcified plaque that, in the opinion of the investigator, would prevent proper administration of the study medication.
- Has an isolated hourglass deformity of the penis.
- Has a plaque causing a curvature of the penis located proximal to the base of the penis where injection of local anesthetic would interfere with the injection of Xiaflex®.
- Has received intralesional or injection therapy for Peyronie's disease including interferon, verapamil, or Xiaflex® < 6 months prior to screening.
- Has used antiplatelet or anti-coagulants (e.g. coumadin, Plavix®, Eliquis®, Effient®) within 7 days prior to each Xiaflex® injection. Daily aspirin of 81 mg is acceptable.
- Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6 months prior to screening or plans to have ESWT at any time during the study.
- Has uncontrolled hypertension as determined by the investigator.
- Has a recent history of stroke, bleeding, or other significant medical condition which, in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
- Has a planned surgical procedure during anticipated study participation.
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
- Has received investigational drug or treatment within 30 days of the first dose Xiaflex®.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
Harper Scott, 212-480-3333, info@manhattanmedicalresearch.com
About this study
Official title: A Phase 4, Single-Center, Multiple-Dose, Open-Label Trial to Evaluate the Efficacy of Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response After Prior Xiaflex® Treatment
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.
- Conditions
- Peyronie's Disease
- Being tested
- Xiaflex® 0.58 mg
- Keywords
- Recurrence, Incomplete Response, Worsening, Curvature
- Medical subject headings
- Penile Induration, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaflex® 0.58 mgDrug
0.25 mL injections.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles. Receives: Drug: Xiaflex® 0.58 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the degree of penile curvature
Measurable change in the curvature of penis
Measured: From Screening up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start4 Oct 2018
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manhattan Medical Research Practice, PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor
- Investigators
- Jed Kaminetsky, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767452
- Sponsor's protocol ID
- MMR032018
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Center, Multiple-Dose, Open-Label Trial to Evaluate the Efficacy of Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response After Prior Xiaflex® Treatment
- ClinicalTrials.gov ID
- NCT03767452
- Acronym / sponsor ID
- MMR032018
- Conditions
- Peyronie's Disease
- Keywords
- Recurrence, Incomplete Response, Worsening, Curvature
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Manhattan Medical Research Practice, PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: Xiaflex® 0.58 mgXiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent to participate in the study.
- Male aged ≥18 years old at screening.
- Previously received Xiaflex® treatment and had a partial or complete response.
- Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
- Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral plane at the screening visit. It must be possible to delineate the single plane of maximal curvature for evaluation during the study.
Key exclusion criteria (24 listed)
- Has a penile curvature of < 30 degrees or > 90 degrees at the screening visit.
- Previous allergic reaction to XIAFLEX®.
- Has any of the following conditions:
- Has previously undergone surgery for Peyronie's disease.
- Has an erection which, in the opinion of the investigator, is insufficient to accurately measure the subject's penile deformity after administration of the prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaflex® 0.58 mg0.25 mL injections. | Drug | Single-Arm |
Primary outcome
Change in the degree of penile curvature
Time frame: From Screening up to 24 weeks
Measurable change in the curvature of penis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed Kaminetsky, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiaflex® 0.58 mg in people with Peyronie's Disease, run by Manhattan Medical Research Practice, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harper Scott (212-480-3333, info@manhattanmedicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the degree of penile curvature (time frame: From Screening up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.