Cutaneous T-Cell LymphomaPhase 2NCT00425555
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
A Phase 2 study testing Panobinostat in people with Cutaneous T-Cell Lymphoma, run by Novartis Pharmaceuticals at 42 sites in 12 countries.
Trial summary
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma
- What is being tested?
- Panobinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 42 sitesin 12 countries
- Study dates
- Jan 2007to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent obtained prior to any screening procedures
- Age ≥ 18 years old
- Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
- Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
- Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
- Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.
Who cannot join
- Prior treatment with an HDAC inhibitor.
- Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
- Impaired cardiac function
- Concomitant use of drugs with a risk of causing torsades de pointes
- Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Less than 3 months since prior electron beam therapy
Show all 15Show fewer
- Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control
- Uncontrolled hypertension
- Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical steroid use is permitted. Topical bexarotene use is prohibited during the trial
- Concomitant use of CYP3A4/5 inhibitors.
- Patients with unresolved diarrhea > CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
42 sites in 12 countries.
42 sites in 12 countries
United States16 sites
University of Michigan Health System Michigan HouseClinTrialsOffice
Ann Arbor, Michigan, 48109
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, 30322
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
Augusta, Georgia, 30912
University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic
Birmingham, Alabama, 35294-0006
Boston Medical Center StudyCoordinator:CLBH589B2201
Boston, Massachusetts, 02118
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)
Boston, Massachusetts, 02215
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed
Chicago, Illinois, 60611
University Dermatology Consultants
Cincinnati, Ohio, 45219
City of Hope National Medical Center
Duarte, California, 91010-3000
MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201
Houston, Texas, 77030
Indiana University Dept. of IU Cancer Center
Indianapolis, Indiana, 46202
University of California at Los Angeles Dept. of Hematology-Oncology
Los Angeles, California, 90095
Florida Academic Dermatology Center
Miami, Florida, 33136
University of Pittsburgh Medical Center Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University Dept. of OHSU Cancer Institute
Portland, Oregon, 97239
Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr
Winston-Salem, North Carolina, 27157
Italy5 sites
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Florence, FI, 50129
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Torino, TO, 10126
Belgium3 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Yvoir, 5530
France3 sites
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Lyon, Cedex 02, 69288
Novartis Investigative Site
Paris, 75010
Germany3 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Minden, 32423
Novartis Investigative Site
Würzburg, 97080
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28041
Argentina2 sites
Novartis Investigative Site
Buenos Aires, C1425AUM
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC
Australia2 sites
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
South Brisbane, Queensland, 4101
Canada2 sites
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
About this study
Official title: A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
- Conditions
- Cutaneous T-Cell Lymphoma
- Being tested
- Panobinostat
- Keywords
- Cutaneous T-Cell Lymphoma, adults, Mycosis Fungoides, Sézary Syndrome, CTCL
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanobinostatDrug
Also called LBH589
| Study group | Role | What they receive |
|---|---|---|
| Previously treated with oral bexarotene | Experimental | Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Receives: Drug: Panobinostat |
| No prior oral bexarotene treatment | Experimental | Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Receives: Drug: Panobinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007).
Responses in the skin based on SWAT are defined as:
- Complete Response (CR): no evidence of skin disease
- Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline
- Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score
- Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
Measured: Baseline up to 6 Months of Follow up
Secondary outcomes (12)
The Overall Response Rate Using mSWAT Skin Score
Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
Measured: Baseline up to Cycle 12, an average of 12 months
Time to Response for Responders
Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Measured: Baseline up to Cycle 12, an average of 12 months
Duration of Response (DOS)
Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Measured: Baseline up to Cycle 12, an average of 12 months
Progression-free Survival (PFS)
PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
Measured: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Measured: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Measured: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Measured: Baseline up to Cycle 12, an average of 12 months
Maximum Plasma Concentration (Cmax) of Panobinostat
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Measured: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Time to Peak Concentration (Tmax) of Panobinostat
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Measured: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Measured: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Time of Clast (Tlast) of Panobinostat
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Measured: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Last Observed Plasma Concentration (Clast) of Panobinostat
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Measured: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425555
- Sponsor's protocol ID
- CLBH589B2201
- Other IDs
- 2006-000880-27
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2007
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbe C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.
PubMed 22981498
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00425555
- Acronym / sponsor ID
- CLBH589B2201
- Conditions
- Cutaneous T-Cell Lymphoma
- Keywords
- Cutaneous T-Cell Lymphoma, adults, Mycosis Fungoides, Sézary Syndrome, CTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Posted 16 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously treated with oral bexarotene | Experimental | Drug: PanobinostatParticipants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). |
| No prior oral bexarotene treatment | Experimental | Drug: PanobinostatParticipants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained prior to any screening procedures
- Age ≥ 18 years old
- Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
- Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
- Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
Key exclusion criteria (15 listed)
- Prior treatment with an HDAC inhibitor.
- Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
- Impaired cardiac function
- Concomitant use of drugs with a risk of causing torsades de pointes
- Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
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 |
|---|---|---|
| PanobinostatAlso: LBH589 | Drug | No prior oral bexarotene treatment, Previously treated with oral bexarotene |
Primary outcome
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
Time frame: Baseline up to 6 Months of Follow up
Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
12 secondary outcomes
The Overall Response Rate Using mSWAT Skin Score
Time frame: Baseline up to Cycle 12, an average of 12 months
Time to Response for Responders
Time frame: Baseline up to Cycle 12, an average of 12 months
Duration of Response (DOS)
Time frame: Baseline up to Cycle 12, an average of 12 months
Progression-free Survival (PFS)
Time frame: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
Time frame: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
Time frame: Baseline up to Cycle 12, an average of 12 months
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
Time frame: Baseline up to Cycle 12, an average of 12 months
Maximum Plasma Concentration (Cmax) of Panobinostat
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Time to Peak Concentration (Tmax) of Panobinostat
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Time of Clast (Tlast) of Panobinostat
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Last Observed Plasma Concentration (Clast) of Panobinostat
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22981498Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbe C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panobinostat in people with Cutaneous T-Cell Lymphoma, run by Novartis Pharmaceuticals at 42 sites in 12 countries.
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 6 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: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Italy, Belgium, France, Germany and 7 more countries. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) (time frame: Baseline up to 6 Months of Follow up). 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 NCT00425555, which also lists 1 linked publication.
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 Aug 2021.