Psoriasis VulgarisPhase 3METOPNCT02902861
Trial in Patients With Psoriasis Treated With Methotrexate Using an Optimized Treatment Schedule (METOP)
A Phase 3 study testing Methotrexate in people with Psoriasis Vulgaris, run by Prof. Kristian Reich at 1 site in Germany.
Trial summary
This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France, the Netherlands and the United Kingdom (UK) 1 center in each country respectively), randomized, double-blinded, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to May 2015
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years of age or older at time of informed consent; may be men or women.
- Are MTX naïve
- Moderate to severe plaques psoriasis (according rule of ten (PASI ≥10 or BSA ≥ 10 or DLQI ≥ 10) for at least 6 months with or without psoriatic arthritis (however, highly active psoriatic arthritis is excluded, defined by. > 5 swollen tender joints or soles and C-Reactive Protein (CRP) >2 x UNL) .
- Women of childbearing potential and all men must be using a highly effective method of contraception (pearl index < 1%) as defined blow and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 6 months after receiving the last injection of Investigational Medicinal Product (IMP).Highly effective method is defined as: Use of oral, injected or implanted hormonal methods, intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Able to adhere to the study visit schedule and other protocol requirements.
- Capable of giving informed consent. The informed consent must be obtained prior to any study related procedures.
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- Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.
- Must agree not to receive a live virus or live bacterial vaccination 4 weeks prior to the first IMP s.c. administration, during the trial and up to 3 months after the last injection.
- Chest X-ray investigation within the last 6 months prior to first s.c. administration of IMP and show no clinically relevant abnormalities
Who cannot join
- Currently have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
- Have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, (hydroxy-) chloroquine, or lithium).
- Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
- Have screening laboratory test results for the following parameters outside the stated ranges (please refer also to :
- Hemoglobin < 10 g/dL
- White blood cells < 3.0 x 109/L
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- Neutrophils < 1.5 x 109/L
- Platelets < 100 x 109/L
- Creatinine clearance (calculated according to Cockcroft-Gault) < 50 mL/min)
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Gamma Glutamyltransferase (γ-GT) levels must be > 2 times the upper limit of normal range
- Bilirubin > 5mg/dl (85,5 μmol/l)
- Hypalbuminemia <3,5 g/dl
- Have used any other IMP within the previous 4 weeks or 5 times the half-life of an investigational agent prior to the first s.c. administration of the IMP of this study, whichever is longer.
- Not able or willing to wash out any prohibited medications as listed below.
- Any biologics; washout 5 times of half-life
- Phototherapy or any systemic medications that could affect the psoriasis (including but not limited to oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, sulfasalazine, hydroxyurea, or fumaric acid derivates), within 4 weeks
- Any topical medications that could affect the psoriasis (e.g. corticosteroids, anthralin, calcipotriene, topical vitamin D derivates, retinoids, tazarotene), within 2 weeks
- Any systemic immunosuppressants (e.g. azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) ,within 4 weeks
- lithium, antimalarial agents To be stopped directly prior to first s.c. administration of IMP
- Intramuscular gold ,Within 4 weeks Patients who take prohibited medications that cannot be washed out within 4 weeks or at least 5 times of the half-life of the investigational agent prior to first s.c.
- administration of IMP should not be asked to participate in the trial.
- Have a history of chronic or recurrent infectious disease or had a serious infection or have been hospitalized or received i.v. antibiotics for the treatment of an infection within 2 months prior to screening.
- History of radiotherapy or planed concomitant radiotherapy
- Ulcers of the oral cavity (e.g. ulcerative stomatitis) and/or known gastrointestinal ulcer disease
- A known B12/cobalamin deficiency
- Known diagnosed ascites or pleural effusions
- Have a history of latent or active Tuberculosis (TB) (prior to screening).
- Have current signs or symptoms of severe, progressive, or uncontrolled renal (specifically with calculated creatinine clearance < 20), hepatic (especially with bilirubin > 5mg/dl (85,5 mol/l), hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
- Have shown a previous immediate hypersensitivity response, including anaphylaxis, to the folic acid
- Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
- Are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months.
- Staff or relatives/partner of any clinical research site
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psoriasis-Zentrum, Universitäts-Hautklinik Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: An International Prospective, Double-blind, Placebo-controlled Phase III Randomised Controlled Trial (RCT) in Patients With Moderate to Severe Psoriasis Are Treated With Subcutaneous (s.c.) Methotrexate Using an Optimized Treatment Schedule.
This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France, the Netherlands and the United Kingdom (UK) 1 center in each country respectively), randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to Placebo as assessed by the primary endpoint "75% reduction of Psoriasis Area Severity Index" (PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious) Adverse Events ((S)AE) occurrence and questionnaires)
Read the detailed description
The present study was initiated to further increase the knowledge about the optimal dosing regimen and to thus optimize the efficacy and safety of MTX treatment for patients with moderate to severe psoriasis. In view of the described risk-benefit profile of MTX, an initial dose of at least 15 mg per week administered subcutaneously followed by 5 mg folic acid p.o. 24 hours after MTX application seems appropriate. Since 20 mg MTX per week has been proven to be beneficial in a considerable part of patients, who did not respond sufficiently to 15 mg MTX per week, in this study the dosing starts with a dose of 17.5 mg MTX per week, administered subcutaneously. At such a starting dose, it was expected to find the highest MTX efficacy possible, but with appropriate safety margins. If in a patient, a "50% reduction of Psoriasis Area Severity Index" PASI50 response is not achieved in week 8, the dose will be increased to 22.5 mg MTX per week. All dosages used in this study lay within the approved dosing range of MTX. The study will be conducted in a double-blind, placebo controlled manner. Placebo was chosen as control since only this comparator allows a reliable interpretation of safety and efficacy data.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Methotrexate, Placebo ( for Methotrexate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX
methotrexate 50 mg/ml in syringes for sub-cutaneous injection; Once weekly (every 7 days) s.c. administration of 17.5 mg MTX; If PASI50 is not reached after 8 weeks, the dosing will be increased to 22.5 mg
Placebo ( for Methotrexate)Drug
NaCl-Solution manufactured to mimic Methotrexate
| Study group | Role | What they receive |
|---|---|---|
| methotrexate | Active comparator | Once weekly (every 7 days) s.c. administration of 17.5 mg MTX. If PASI50 is not reached after 8 weeks (week 8) or PASI75 is not reached after 24 weeks, the dosing will be increased to 22.5 mg MTX/week. If patients were already dosed with 22.5 mg MTX/week in week 24 and PASI50 is not reached, patients will be excluded from treatment. Primary endpoint after 16 weeks. Receives: Drug: Methotrexate |
| Placebo (NaCl-Solution) | Placebo comparator | Once weekly (every 7 days) s.c. administration of 0.35 mL placebo If PASI50 is not reached after 8 weeks (week 8), the dosing will be increased to 0.45 mL placebo/week. Primary endpoint after 16 weeks. After 16 weeks patients will receive 17.5 mg MTX / week. If PASI50 is not reached after 8 weeks of MTX treatment (week 24), uptitration to 22.5 mg MTX/ 0.45 mL Plac / week will be done. Patients, who will reach PASI75 under placebo treatment after 16 weeks, will be dosed neither with placebo nor with MTX until relapse. After relapse the patients will be dosed with a starting dose of 17.5 mg MTX / week. Receives: Drug: Placebo ( for Methotrexate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in 75% reduction of Psoriasis Area Severity Index (PASI75) responder rate between treatment arms
Measured: week 16
Secondary outcomes (19)
Difference in PASI75 responder rate between treatment arms
Measured: weeks 52
Difference in 50% reduction of Psoriasis Area Severity Index (PASI50)
Measured: weeks 15 and 52
Difference in 90% reduction of Psoriasis Area Severity Index (PASI90)
Measured: weeks 15 and 52
PASI75 in placebo arm (cross-over)
Measured: weeks 32
Difference in Nail Psoriasis Severity Index (NAPSI)
Measured: weeks 16 and 52
Difference in Body Surface Area Index (BSA)
Measured: weeks 16 and 52
Difference in Physician's Global Assessment (PGA)
Measured: weeks 16 and 52
Difference in Psoriatic Arthritis Index (PsA)
Measured: weeks 16 and 52
Difference in Patient's satisfaction with metex® pre-filled syringe (PSAT metex®)
Measured: weeks 16 and 52
Difference in Dermatology Life Quality Index (DLQI)
Measured: weeks 16 and 52
Difference in European Qualification-5D-Questionnaire (EQ-5D)
Measured: weeks 16 and 52
Safety and tolerability assessed by Adverse Events (AE)/ Serious Adverse Events (SAE) tolerability at the site of administration
Measured: week 0 - week 51
Safety and tolerability assessed by laboratory values
Measured: week 0 - week 51
local tolerability at the site of administration assessed by Erythema
Erythema (redness): diameter (mm) and severity from none to severe (0 = none,
1= mild, 2 = moderate 3 = severe)
Measured: week 0 - week 51
local tolerability at the site of administration assessed by Swelling
Swelling/Induration: diameter (mm) and severity from none to severe (0 = none,
1= mild, 2 = moderate 3 = severe)
Measured: week 0 - week 51
local tolerability at the site of administration assessed by Hematoma
Hematoma: yes/ no and if present diameter (mm)
Measured: week 0 - week 51
local tolerability at the site of administration assessed by Local Pain
Local pain - assessed by the study subject on a visual analogue scale (1-10)
Measured: week 0 - week 51
local tolerability at the site of administration assessed by Pruritus
Pruritus - assessed by the study subject on a visual analogue scale (1-10)
Measured: week 0 - week 51
Changes of levels of molecular biologic analysis
Measured: at baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Kristian Reich
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Prof. Kristian Reich, Sciderm GmbH
- Investigators
- Ulrich Mrowietz, Professor, Principal investigator, Psoriasis-Zentrum, Universitäts-Hautklinik Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902861
- Sponsor's protocol ID
- 165-001
- Other IDs
- 2012-002716-10
- Acronym
- METOP
- Status last verified
- Sep 2016
- First submitted
- 26 Jul 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Prospective, Double-blind, Placebo-controlled Phase III Randomised Controlled Trial (RCT) in Patients With Moderate to Severe Psoriasis Are Treated With Subcutaneous (s.c.) Methotrexate Using an Optimized Treatment Schedule.
- ClinicalTrials.gov ID
- NCT02902861
- Acronym / sponsor ID
- METOP / 165-001
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Prof. Kristian ReichIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France, the Netherlands and the United Kingdom (UK) 1 center in each country respectively), randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to Placebo as assessed by the primary endpoint "75% reduction of Psoriasis Area Severity Index" (PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious) Adverse Events ((S)AE) occurrence and questionnaires)
Detailed description
The present study was initiated to further increase the knowledge about the optimal dosing regimen and to thus optimize the efficacy and safety of MTX treatment for patients with moderate to severe psoriasis. In view of the described risk-benefit profile of MTX, an initial dose of at least 15 mg per week administered subcutaneously followed by 5 mg folic acid p.o. 24 hours after MTX application seems appropriate. Since 20 mg MTX per week has been proven to be beneficial in a considerable part of patients, who did not respond sufficiently to 15 mg MTX per week, in this study the dosing starts with a dose of 17.5 mg MTX per week, administered subcutaneously. At such a starting dose, it was expected to find the highest MTX efficacy possible, but with appropriate safety margins. If in a patient, a "50% reduction of Psoriasis Area Severity Index" PASI50 response is not achieved in week 8, the dose will be increased to 22.5 mg MTX per week. All dosages used in this study lay within the approved dosing range of MTX. The study will be conducted in a double-blind, placebo controlled manner. Placebo was chosen as control since only this comparator allows a reliable interpretation of safety and efficacy data.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methotrexate | Active comparator | Drug: MethotrexateOnce weekly (every 7 days) s.c. administration of 17.5 mg MTX. If PASI50 is not reached after 8 weeks (week 8) or PASI75 is not reached after 24 weeks, the dosing will be increased to 22.5 mg MTX/week. If patients were already dosed with 22.5 mg MTX/week in week 24 and PASI50 is not reached, patients will be excluded from treatment. Primary endpoint after 16 weeks. |
| Placebo (NaCl-Solution) | Placebo comparator | Drug: Placebo ( for Methotrexate)Once weekly (every 7 days) s.c. administration of 0.35 mL placebo If PASI50 is not reached after 8 weeks (week 8), the dosing will be increased to 0.45 mL placebo/week. Primary endpoint after 16 weeks. After 16 weeks patients will receive 17.5 mg MTX / week. If PASI50 is not reached after 8 weeks of MTX treatment (week 24), uptitration to 22.5 mg MTX/ 0.45 mL Plac / week will be done. Patients, who will reach PASI75 under placebo treatment after 16 weeks, will be dosed neither with placebo nor with MTX until relapse. After relapse the patients will be dosed with a starting dose of 17.5 mg MTX / week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are 18 years of age or older at time of informed consent; may be men or women.
- Are MTX naïve
- Moderate to severe plaques psoriasis (according rule of ten (PASI ≥10 or BSA ≥ 10 or DLQI ≥ 10) for at least 6 months with or without psoriatic arthritis (however, highly active psoriatic arthritis is excluded, defined by. > 5 swollen tender joints or soles and C-Reactive Protein (CRP) >2 x UNL) .
- Women of childbearing potential and all men must be using a highly effective method of contraception (pearl index < 1%) as defined blow and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 6 months after receiving the last injection of Investigational Medicinal Product (IMP).Highly effective method is defined as: Use of oral, injected or implanted hormonal methods, intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (33 listed)
- Currently have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
- Have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, (hydroxy-) chloroquine, or lithium).
- Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
- Have screening laboratory test results for the following parameters outside the stated ranges (please refer also to :
- Have used any other IMP within the previous 4 weeks or 5 times the half-life of an investigational agent prior to the first s.c. administration of the IMP of this study, whichever is longer.
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 |
|---|---|---|
| MethotrexateAlso: MTXmethotrexate 50 mg/ml in syringes for sub-cutaneous injection; Once weekly (every 7 days) s.c. administration of 17.5 mg MTX; If PASI50 is not reached after 8 weeks, the dosing will be increased to 22.5 mg | Drug | methotrexate |
| Placebo ( for Methotrexate)NaCl-Solution manufactured to mimic Methotrexate | Drug | Placebo (NaCl-Solution) |
Primary outcome
Difference in 75% reduction of Psoriasis Area Severity Index (PASI75) responder rate between treatment arms
Time frame: week 16
19 secondary outcomes
Difference in PASI75 responder rate between treatment arms
Time frame: weeks 52
Difference in 50% reduction of Psoriasis Area Severity Index (PASI50)
Time frame: weeks 15 and 52
Difference in 90% reduction of Psoriasis Area Severity Index (PASI90)
Time frame: weeks 15 and 52
PASI75 in placebo arm (cross-over)
Time frame: weeks 32
Difference in Nail Psoriasis Severity Index (NAPSI)
Time frame: weeks 16 and 52
Difference in Body Surface Area Index (BSA)
Time frame: weeks 16 and 52
Difference in Physician's Global Assessment (PGA)
Time frame: weeks 16 and 52
Difference in Psoriatic Arthritis Index (PsA)
Time frame: weeks 16 and 52
Difference in Patient's satisfaction with metex® pre-filled syringe (PSAT metex®)
Time frame: weeks 16 and 52
Difference in Dermatology Life Quality Index (DLQI)
Time frame: weeks 16 and 52
Difference in European Qualification-5D-Questionnaire (EQ-5D)
Time frame: weeks 16 and 52
Safety and tolerability assessed by Adverse Events (AE)/ Serious Adverse Events (SAE) tolerability at the site of administration
Time frame: week 0 - week 51
Safety and tolerability assessed by laboratory values
Time frame: week 0 - week 51
local tolerability at the site of administration assessed by Erythema
Time frame: week 0 - week 51
local tolerability at the site of administration assessed by Swelling
Time frame: week 0 - week 51
local tolerability at the site of administration assessed by Hematoma
Time frame: week 0 - week 51
local tolerability at the site of administration assessed by Local Pain
Time frame: week 0 - week 51
local tolerability at the site of administration assessed by Pruritus
Time frame: week 0 - week 51
Changes of levels of molecular biologic analysis
Time frame: at baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Ulrich Mrowietz, Professor principal investigator
Psoriasis-Zentrum, Universitäts-Hautklinik Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with Psoriasis Vulgaris, run by Prof. Kristian Reich at 1 site in Germany.
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 33 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 16 Sep 2016. 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 Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in 75% reduction of Psoriasis Area Severity Index (PASI75) responder rate between treatment arms (time frame: week 16). 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 16 Sep 2016.