Metastatic Neoplasm to the SpinePhase 2SPORTSMENNCT05617716
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
A Phase 2 study testing Conventional external beam radiation therapy dose (EBRT), Spine radiosurgery/stereotactic body radiation therapy standard dose and Spine radiosurgery/stereotactic body radiation therapy high dose in people with Metastatic Neoplasm to the Spine and Metastatic Neoplasm, run by University of Oklahoma at 2 sites in United States.
Trial summary
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neoplasm to the Spine, Metastatic Neoplasm
- What is being tested?
- Conventional external beam radiation therapy dose (EBRT), Spine radiosurgery/stereotactic body radiation therapy standard dose and Spine radiosurgery/stereotactic body radiation therapy high dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2025to 30 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
- Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.
- Age >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.
- Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
- Participant must have a worst pain score < 2 of 10 according to the Brief Pain Inventory
- Participant must have no intention of changing pain medications on the first day of SBRT
Show all 9Show fewer
- Participant must have a Spinal Instability score (SINS) ≤ 12
- Participant must be a spine SBRT candidate per Radiation Oncology
- Participant must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participant receiving any other investigational agents.
- Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
- Participant is unable to receive MRI of the spine
- Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
Show all 15Show fewer
- Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
- Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
- Participant is not an SBRT candidate per radiation oncology discretion
- Participant has a known primary and has an estimated median survival≤ 3 months
- Participant has an unknown primary
- Participant has a Brief Pain Inventory score > 2
- Participant has received previous radiation therapy involving the intended SBRT treatment field
- Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
- Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Johns Hopkins University Hospitals
Baltimore, Maryland, 21287
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Shearwood McClelland III, MD, 405-271-3016, Shearwood-McClelland@ouhsc.edu
About this study
Official title: Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Read the detailed description
Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates.
Patients in this trial will be randomized in a 1:1:1 ratio into one of three treatment arms: SBRT (24 Gy in 2 fractions), SBRT (19 Gy in 1 fraction), or conventional EBRT (8 Gy in 1 fraction). Participants will complete three questionnaires-the Brief Pain Inventory, COST-FACIT, and EuroQol EQ-5D-at baseline and again during the 3- to 12-month follow-up period.
- Being tested
- Conventional external beam radiation therapy dose (EBRT), Spine radiosurgery/stereotactic body radiation therapy standard dose, Spine radiosurgery/stereotactic body radiation therapy high dose
- Keywords
- Radiosurgery, External Beam Radiation Therapy, Stereotactic Body Radiation Therapy, Spine Stereotactic Radiosurgery
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional external beam radiation therapy dose (EBRT)Radiation
Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
Spine radiosurgery/stereotactic body radiation therapy standard doseRadiation
Participants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
Spine radiosurgery/stereotactic body radiation therapy high doseRadiation
Participants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Standard SBRT | Experimental | Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care. Receives: Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose |
| High Dose SBRT (SOC) | Experimental | Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care. Receives: Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose |
| Conventional EBRT (SOC) | Experimental | Participants will undergo External Beam Radiation Therapy as part of standard of care. Receives: Radiation: Conventional external beam radiation therapy dose (EBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience 3-month pain freedom based on BPI score
Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
Measured: 3 months
Secondary outcomes (7)
Proportion of patients who experienced 6-month pain freedom based on the BPI score
Freedom from pain at 6 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
Measured: 6 months
Local control actuarial rate at 6-months
6-month local control, defined as an actuarial 6-month rate of any new, recurrent or progressing (as defined by SPINOcriteria) tumor within the planning target volume on any post-treatment MRI by 6 months. Follow-up MRIs will be fused with the planning scan for this assessment
Measured: 6 months
Vertebral compression fracture rate at 6-months
6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months
Measured: 6 months
Proportion of patients who experienced progression-free survival
Overall participant survival
Measured: 6 months
Vertebral compression fracture rate at 12-months
12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months
Measured: 12 months
Perceived demographic disparities in patients at 3-month follow-up
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months
Measured: 3 months
Perceived demographic disparities in patients at 6-month follow-up
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start9 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Neoplasm to the SpineStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective phase II randomized trial to determine the optimal spine SBRT regimen for achieving pain freedom at 3 months.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shearwood McClelland III, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617716
- Sponsor's protocol ID
- OU-SCC-SPORTSMEN
- Acronym
- SPORTSMEN
- Status last verified
- Oct 2025
- First submitted
- 8 Nov 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oboh EC, Anwar M, Perry L, Cleaver N, McClelland S 3rd. Early Economic and Patient-Centered Outcomes Before Spine Metastases Radiation Therapy From an Ongoing Phase II Randomized Controlled Trial. Am J Clin Oncol. 2026 Jun 16. doi: 10.1097/COC.0000000000001346. Online ahead of print.
PubMed 42302152Gardner UG Jr, Brawley OW, Obi EE, Redmond KJ, McClelland S 3rd. Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial. Am J Clin Oncol. 2025 Jun 1;48(6):310-313. doi: 10.1097/COC.0000000000001174. Epub 2025 Feb 11.
PubMed 39930584McClelland S 3rd, Sun Y, Spratt DE. Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN): a randomized phase II study protocol. Rep Pract Oncol Radiother. 2023 Jul 25;28(3):379-388. doi: 10.5603/RPOR.a2023.0037. eCollection 2023.
PubMed 37795393
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05617716
- Acronym / sponsor ID
- SPORTSMEN / OU-SCC-SPORTSMEN
- Keywords
- Radiosurgery, External Beam Radiation Therapy, Stereotactic Body Radiation Therapy, Spine Stereotactic Radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 Nov 2022 (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.
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Detailed description
Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates.
Patients in this trial will be randomized in a 1:1:1 ratio into one of three treatment arms: SBRT (24 Gy in 2 fractions), SBRT (19 Gy in 1 fraction), or conventional EBRT (8 Gy in 1 fraction). Participants will complete three questionnaires-the Brief Pain Inventory, COST-FACIT, and EuroQol EQ-5D-at baseline and again during the 3- to 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective phase II randomized trial to determine the optimal spine SBRT regimen for achieving pain freedom at 3 months.
| Arm | Type | Receives |
|---|---|---|
| Standard SBRT | Experimental | Radiation: Spine radiosurgery/stereotactic body radiation therapy standard doseParticipants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care. |
| High Dose SBRT (SOC) | Experimental | Radiation: Spine radiosurgery/stereotactic body radiation therapy high doseParticipants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care. |
| Conventional EBRT (SOC) | Experimental | Radiation: Conventional external beam radiation therapy dose (EBRT)Participants will undergo External Beam Radiation Therapy as part of standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
- Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.
- Age >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.
- Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
- Participant must have a worst pain score < 2 of 10 according to the Brief Pain Inventory
Key exclusion criteria (15 listed)
- Participant receiving any other investigational agents.
- Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
- Participant is unable to receive MRI of the spine
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 |
|---|---|---|
| Conventional external beam radiation therapy dose (EBRT)Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up. | Radiation | Conventional EBRT (SOC) |
| Spine radiosurgery/stereotactic body radiation therapy standard doseParticipants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up. | Radiation | Standard SBRT |
| Spine radiosurgery/stereotactic body radiation therapy high doseParticipants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up. | Radiation | High Dose SBRT (SOC) |
Primary outcome
Proportion of patients who experience 3-month pain freedom based on BPI score
Time frame: 3 months
Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
7 secondary outcomes
Proportion of patients who experienced 6-month pain freedom based on the BPI score
Time frame: 6 months
Local control actuarial rate at 6-months
Time frame: 6 months
Vertebral compression fracture rate at 6-months
Time frame: 6 months
Proportion of patients who experienced progression-free survival
Time frame: 6 months
Vertebral compression fracture rate at 12-months
Time frame: 12 months
Perceived demographic disparities in patients at 3-month follow-up
Time frame: 3 months
Perceived demographic disparities in patients at 6-month follow-up
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Derived from this study: PubMed 42302152Oboh EC, Anwar M, Perry L, Cleaver N, McClelland S 3rd. Early Economic and Patient-Centered Outcomes Before Spine Metastases Radiation Therapy From an Ongoing Phase II Randomized Controlled Trial. Am J Clin Oncol. 2026 Jun 16. doi: 10.1097/COC.0000000000001346. Online ahead of print.
- Derived from this study: PubMed 39930584Gardner UG Jr, Brawley OW, Obi EE, Redmond KJ, McClelland S 3rd. Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial. Am J Clin Oncol. 2025 Jun 1;48(6):310-313. doi: 10.1097/COC.0000000000001174. Epub 2025 Feb 11.
- Derived from this study: PubMed 37795393McClelland S 3rd, Sun Y, Spratt DE. Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN): a randomized phase II study protocol. Rep Pract Oncol Radiother. 2023 Jul 25;28(3):379-388. doi: 10.5603/RPOR.a2023.0037. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Neoplasm to the Spine
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruitingPhase 2
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Spinal Metastases
RecruitingPhase 1/2
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
Spine Metastases
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
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.
Shearwood McClelland III, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional external beam radiation therapy dose (EBRT), Spine radiosurgery/stereotactic body radiation therapy standard dose and Spine radiosurgery/stereotactic body radiation therapy high dose in people with Metastatic Neoplasm to the Spine and Metastatic Neoplasm, run by University of Oklahoma at 2 sites 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Onco Nurse (405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience 3-month pain freedom based on BPI score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05617716, which also lists 3 linked publications.
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 20 Oct 2025.