ADHDPhase 3NCT02139111
PRC-063 in Adolescent ADHD
A Phase 3 study testing PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 43 sites in 2 countries.
Trial summary
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Apr 2014to 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must be male or non-pregnant female at least 12 years of age and less than 18 years of age.
- Must have an ADHD diagnosis, in attentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Must be unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
- Female subjects of Child-Bearing Potential (FOCP) must be a negative serum β-hCG pregnancy test at screening.
- Must have a minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the WASI or the KBIT.
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- Mentally and physically competent to sign an informed assent document, in the case of the subject, and an informed consent document, in the case of the parent/guardian, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Able and willing to comply with the study procedures for the entire length of the study, including a successful swallow test of an empty 85 mg capsule.
- Total score of 24 or greater on the clinician-rated ADHA-5-RS, as assessed at Visit 2
Who cannot join
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or have serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
- Clinically significant laboratory abnormalities, as assessed at Visit 1.
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- Currently receiving guanethidine, pressor agents, MAO inhibitors, coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), phenylbutazone, tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors (SSRIs) or herbal remedies (unless on a stable dose for 4 weeks).
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke or other serious cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subjects who are currently considered a suicide risk by the investigator.
- Having a primary diagnosis of schizophrenia, schizoaffective disorder, primary affective disorder, schizotypal personality, major depression, bipolar disorder, generalized anxiety, borderline personality disorder, antisocial personality or another unstable psychiatric condition requiring treatment, as assessed by the structured interview conducted at Visit 1.
- Having a history or suspected physiological dependence (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
- Excessive consumption of alcohol (consumes alcohol in quantities greater than 15 drinks per week; 1 drink is defined as 360 mL/12 oz. of beer, 120 mL/4 oz. of wine, or 30 mL/1 oz. of hard liquor), or history (within previous 6 months) of alcohol abuse.
- Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device.
- Homeless.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States31 sites
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Advanced Clinical Research
Boise, Idaho, 83642
Florida Clinical Research Center
Bradenton, Florida, 34201
University of Cincinnati
Cincinnati, Ohio, 45219
Ericksen Research
Clinton, Utah, 84015
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27705
Northwest Clinical Research Center
Friday Harbor, Washington, 98007
Sarkis Clinical Research
Gainesville, Florida, 32607
Sarkis Clinical Trials
Gainesville, Florida, 32607
NeuroScience
Herndon, Virginia, 20170
Bayou City Research Ltd
Houston, Texas, 77007
Red Oak Psychiatry Associates
Houston, Texas, 77090
Houston Clinical Trials
Houston, Texas, 77098
CNS Healthcare Jacksonville
Jacksonville, Florida, 32256
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
UCLA
Los Angeles, California, 90095
Florida Clinical Research Center
Maitlin, Florida, 32751
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38105
Synergy Clinical Research
National City, California, 91950
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
IPS Research Company
Oklahoma City, Oklahoma, 73103
Orange County Neuro Phychiatry Research Centre
Orange, California, 92868
Clinical Neuroscience Solutions
Orlando, Florida, 32806
Wake Research Associates
Raleigh, North Carolina, 27612
Physiciatric and Behavioral Solutions
Salt Lake City, Utah, 84105
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143
Stedman Clinical Trials
Tampa, Florida, 33613
Canada12 sites
Mathison Centre for Mental Health Research and Education
Calgary, Alberta, T2N 4Z6
University of Calgary
Calgary, Alberta, T2N 4Z6
Atlantic ADHD Centre
Dartmouth, Nova Scotia, B2Y 1H6
Chokka Center for Integrative Health
Edmonton, Alberta, T6L 6W6
McMaster University
Hamilton, Ontario
McGill University Health Centre
Montreal, Quebec, H3Z 1P2
Doctors Jackiewicz Professional Medical Corporation
Niagra Falls, Ontario, L2E 6A4
Dr. Judy van Stralen
Ottawa, Ontario, K2G 1W2
Royal University Hospital Saskatoon
Saskatoon, Saskatchewan, S7N OW8
Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic
Toronto, Ontario, M5G 1N8
Dr. Margaret Weiss
Vancouver, British Columbia, V7V 3R8
The Kids Clinic
Whitby, Ontario, L1N 2L1
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.
Read the detailed description
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with ADHD will be randomized to PRC-063 (25, 45, 70 or 85 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.
- Conditions
- ADHD
- Being tested
- Placebo, PRC-063 25 mg, PRC-063 45 mg, PRC-063 70 mg, PRC-063 85 mg
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo capsule
Oral placebo capsule
PRC-063 25 mgDrug
Also called 25 mg capsule
Oral 25 mg capsule - active
PRC-063 45 mgDrug
Also called 45 mg capsule
Oral 45 mg capsule - active
PRC-063 70 mgDrug
Also called 70 mg capsule
Oral 70 mg capsule - active
PRC-063 85 mgDrug
Also called 85 mg capsule
Oral 85 mg capsule - active
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Arm Receives: Drug: Placebo |
| PRC-063 25 mg and Placebo | Active comparator | PRC-063 25 mg and placebo capsule by mouth once daily Receives: Drug: Placebo; Drug: PRC-063 25 mg |
| PRC-063 45 mg and Placebo | Active comparator | PRC-063 45 mg and placebo capsule by mouth once daily Receives: Drug: Placebo; Drug: PRC-063 45 mg |
| PRC-063 70 mg and Placebo | Active comparator | PRC-063 70 mg and placebo capsule by mouth once daily Receives: Drug: Placebo; Drug: PRC-063 70 mg |
| PRC-063 85 mg and Placebo | Active comparator | PRC-063 85 mg and placebo capsule by mouth once daily Receives: Drug: Placebo; Drug: PRC-063 85 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinician-administered ADHD-5-Rating Scale
Measured: Baseline week 2, weeks 3-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
- Investigators
- Joseph Reiz, Study director, Purdue Pharma LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139111
- Sponsor's protocol ID
- 063-009
- Status last verified
- Jul 2015
- First submitted
- 12 May 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
PubMed 41342306Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
PubMed 36971690Weiss MD, Surman C, Khullar A, Owens J, He E, Cataldo M, Donnelly G. Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):623-630. doi: 10.1089/cap.2021.0087. Epub 2021 Oct 28.
PubMed 34714112Weiss MD, Cutler AJ, Kollins SH, Donnelly GAE. Efficacy and Safety of a Long-Acting Multilayer-Release Methylphenidate Formulation (PRC-063) in the Treatment of Adolescent Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Clinical Trial with a 6-Month Open-Label Extension. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):610-622. doi: 10.1089/cap.2021.0034. Epub 2021 Oct 8.
PubMed 34637343
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients
- ClinicalTrials.gov ID
- NCT02139111
- Acronym / sponsor ID
- 063-009
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 May 2014 (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.
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.
Detailed description
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with ADHD will be randomized to PRC-063 (25, 45, 70 or 85 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Arm |
| PRC-063 25 mg and Placebo | Active comparator | Drug: Placebo, Drug: PRC-063 25 mgPRC-063 25 mg and placebo capsule by mouth once daily |
| PRC-063 45 mg and Placebo | Active comparator | Drug: Placebo, Drug: PRC-063 45 mgPRC-063 45 mg and placebo capsule by mouth once daily |
| PRC-063 70 mg and Placebo | Active comparator | Drug: Placebo, Drug: PRC-063 70 mgPRC-063 70 mg and placebo capsule by mouth once daily |
| PRC-063 85 mg and Placebo | Active comparator | Drug: Placebo, Drug: PRC-063 85 mgPRC-063 85 mg and placebo capsule by mouth once daily |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Must be male or non-pregnant female at least 12 years of age and less than 18 years of age.
- Must have an ADHD diagnosis, in attentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Must be unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
- Female subjects of Child-Bearing Potential (FOCP) must be a negative serum β-hCG pregnancy test at screening.
Key exclusion criteria (15 listed)
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or have serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
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 |
|---|---|---|
| PlaceboAlso: Placebo capsuleOral placebo capsule | Drug | PRC-063 25 mg and Placebo, PRC-063 45 mg and Placebo, PRC-063 70 mg and Placebo, PRC-063 85 mg and Placebo, Placebo |
| PRC-063 25 mgAlso: 25 mg capsuleOral 25 mg capsule - active | Drug | PRC-063 25 mg and Placebo |
| PRC-063 45 mgAlso: 45 mg capsuleOral 45 mg capsule - active | Drug | PRC-063 45 mg and Placebo |
| PRC-063 70 mgAlso: 70 mg capsuleOral 70 mg capsule - active | Drug | PRC-063 70 mg and Placebo |
| PRC-063 85 mgAlso: 85 mg capsuleOral 85 mg capsule - active | Drug | PRC-063 85 mg and Placebo |
Primary outcome
Change from Baseline in Clinician-administered ADHD-5-Rating Scale
Time frame: Baseline week 2, weeks 3-6
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 8 Jul 2015.
- Derived from this study: PubMed 41342306Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
- Derived from this study: PubMed 36971690Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
- Derived from this study: PubMed 34714112Weiss MD, Surman C, Khullar A, Owens J, He E, Cataldo M, Donnelly G. Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):623-630. doi: 10.1089/cap.2021.0087. Epub 2021 Oct 28.
- Derived from this study: PubMed 34637343Weiss MD, Cutler AJ, Kollins SH, Donnelly GAE. Efficacy and Safety of a Long-Acting Multilayer-Release Methylphenidate Formulation (PRC-063) in the Treatment of Adolescent Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Clinical Trial with a 6-Month Open-Label Extension. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):610-622. doi: 10.1089/cap.2021.0034. Epub 2021 Oct 8.
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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.
Joseph Reiz study director
Purdue Pharma LP
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 43 sites in 2 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 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: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Canada. 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?
Change from Baseline in Clinician-administered ADHD-5-Rating Scale (time frame: Baseline week 2, weeks 3-6). 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 NCT02139111, which also lists 4 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 8 Jul 2015.