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Schizoaffective DisorderPhase 3NCT01193153

A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

A Phase 3 study testing paliperidone palmitate in people with Schizoaffective Disorder, run by Janssen Scientific Affairs, LLC at 80 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizoaffective Disorder
What is being tested?
paliperidone palmitate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
667 participants
Where
80 sitesin 8 countries
Study dates
Sep 2010to Oct 2013
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DSM-IV diagnosis of schizoaffective disorder
  • Experiencing an acute exacerbation of psychotic symptoms
  • A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
  • A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
  • Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements

Who cannot join

  • A primary active mental illness diagnosis other than schizoaffective disorder
  • Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
  • Subjects with first episode of psychosis
  • Received electroconvulsive therapy in the past 3 months
  • History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
  • Received long-acting antipsychotic medication within 2 injection cycles
Show all 13Show fewer
  • Received therapy with clozapine within 3 months
  • A history of neuroleptic malignant syndrome
  • Previous history of lack of response to antipsychotic medication
  • Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening
  • Receiving therapy with carbamazepine
  • Receiving therapy with monoamine oxidase inhibitors
  • Pregnant, breast-feeding, or planning to become pregnant

Trial locations and contacts

80 sites in 8 countries.

80 sites in 8 countries

United States28 sites
  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Cedarhurst, New York

  • Study site

    Charlotte, North Carolina

  • Study site

    Cleveland, Ohio

  • Study site

    Creve Coeur, Missouri

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Flowood, Mississippi

  • Study site

    Garden Grove, California

  • Study site

    Hollywood, Florida

  • Study site

    Irving, Texas

  • Study site

    Maitland, Florida

  • Study site

    Marietta, Georgia

  • Study site

    North Miami, Florida

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pico Rivera, California

  • Study site

    Riverside, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Schamburg, Illinois

  • Study site

    Staten Island, New York

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Wichita, Kansas

Other trials in United States

India13 sites
  • Study site

    Ahmedabad

  • Study site

    Chennai

  • Study site

    Chhatrapati Sambhajinagar

  • Study site

    Jaipur

  • Study site

    Lucknow Gpo

  • Study site

    Mangalore

  • Study site

    Mysore

  • Study site

    Nashik

  • Study site

    Pune

  • Study site

    Uttar Pradesh

  • Study site

    Vadadora

  • Study site

    Varanasi

  • Study site

    Vijaywada

Other trials in India

Ukraine11 sites
  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Hlevakha

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Poltava

  • Study site

    Simferopol

  • Study site

    Uzhhorod

  • Study site

    Village Stepanovka Kherson

  • Study site

    Vinnitsa

Other trials in Ukraine

Romania7 sites
  • Study site

    Arad

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Oradea

  • Study site

    Sibiu

  • Study site

    Timișoara

Other trials in Romania

South Africa7 sites
  • Study site

    Cape Town

  • Study site

    Centurion Gauteng

  • Study site

    Durban

  • Study site

    George

  • Study site

    Johannesburg

  • Study site

    Pretoria

  • Study site

    Tyger Valley

Other trials in South Africa

Malaysia6 sites
  • Study site

    Alor Star

  • Study site

    Ipoh

  • Study site

    Kota Bharu

  • Study site

    Kota Kinabalu

  • Study site

    Kuala Lumpur

  • Study site

    Tanjong Rambutan

Other trials in Malaysia

Bulgaria4 sites
  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

Philippines4 sites
  • Study site

    Cebu

  • Study site

    Davao City

  • Study site

    Iloilo City

  • Study site

    Quezon City

Other trials in Philippines

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder

This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.

Read the detailed description

Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To date however, no medication has been evaluated in the maintenance treatment of schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative to placebo in delaying the time to relapse in patients with schizoaffective disorder. This study explores the use of paliperidone palmitate either as monotherapy or as an adjunct to mood stabilizers or antidepressants (MS/AD) because both treatment approaches are commonly used in the clinical management of schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 13-week open-label flexible dose lead-in period, a 12-week open-label fixed dose stabilization period, and a 15 months double-blind relapse prevention period. Patients without previous exposure to paliperidone ER (Invega), paliperidone palmitate (Invega Sustenna), risperidone, or RISPERDAL CONSTA will be given 4 to 6 days of paliperidone ER 6mg/day for tolerability testing. Patients can continue their current antipsychotic regimen through Day -1 (the day before the start of the study period). During the open-label periods, all patients will be treated with paliperidone palmitate. An initial loading dose of 234 mg (150 mg eq.) of paliperidone palmitate will be given by deltoid injection followed by 156 mg (100 mg eq.) deltoid injection on Day 8. Starting on Day 36, injections may be administered in either the deltoid muscle or the gluteal muscle. Doses at Days 36, 64 and 92 may be increased or decreased within the range of 78 mg (50 mg eq.) and 234 mg (150 mg. eq.) as clinically indicated. Dose will be fixed (at Day 92 dose) during the 12-week stabilization period. Patients who meet pre-determined stabilization criteria will be eligible to enter the double-blind relapse prevention period and will be randomly assigned to either receive paliperidone palmitate (at the Day 92 dose) or placebo treatment. Patients will have intramuscular (i.m.) study drug injection and efficay and saftety evaluations performed every 4 weeks throughout the study. Efficacy will be evaluated during the study using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating Scale for Depression (HAM-D). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study. Participation in pharmacogenomic research is optional. Blood samples will be taken from patients being treated with lithium or valproate for the measurement of blood lithium or valproate levels. Approximately 52 mL (31 mL for patients who are not receiving lithium or valproate) of whole blood will be collected during the study. All patients will receive paliperidone palmitate 78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for the the first 25 weeks of the study (open-label periods). During the 15-month double-blind relapse prevention period, one half of the patients will be randomized to paliperidone palmitate treatment (50, 75, 100, or 150 mg eq. monthly i.m. injection) and the other half of the patients will be randomized to monthly placebo injection.

Being tested
Placebo, paliperidone palmitate
Keywords
schizoaffective disorder, paliperidone palmitate, INVEGA SUSTENNA, schizoaffective disorder relapse prevention
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    monthly by i.m. injection for 15 months

  • paliperidone palmitateDrug

    78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months

Study groups in NCT01193153
Study groupRoleWhat they receive
001Experimentalpaliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months
Receives: Drug: paliperidone palmitate
002Placebo comparatorPlacebo monthly by i.m. injection for 15 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Double-blind: Percentage of Participants Who Experienced Relapse

    Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.

    Measured: Day 1 up to Month 15 of double blind relapse prevention period

Secondary outcomes (12)
  1. Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])

    The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.

    Measured: Baseline and Week 64 of double blind relapse prevention period

  2. Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint

    The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.

    Measured: Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period

  3. Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint

    The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.

    Measured: Baseline and Endpoint (Week 64/LOCF) in double-blind period

  4. Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores

    The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.

    Measured: Baseline and Endpoint (Week 64/LOCF) in DB period

  5. Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint

    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

    Measured: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period

  6. Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint

    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

    Measured: Baseline and Endpoint (Week 64/LOCF) in double-blind period

  7. Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint

    The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.

    Measured: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period

  8. Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint

    The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.

    Measured: Baseline and Endpoint (Week 64/LOCF) in double-blind period

  9. Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint

    The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.

    Measured: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period

  10. Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint

    The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.

    Measured: Baseline and Endpoint (Week 64/LOCF) in double-blind period

  11. Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint

    The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".

    Measured: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period

  12. Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint

    The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".

    Measured: Baseline and Endpoint (Week 64/LOCF) in double-blind period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01193153
Sponsor's protocol ID
CR016618
Other IDs
R092670SCA3004
Status last verified
Dec 2014
First submitted
30 Aug 2010
Last updated
5 Jan 2015
Data monitoring committee
No

Publications

  • Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.

    PubMed 26934062
  • Fu DJ, Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, Canuso CM, Alphs L. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015 Mar;76(3):253-62. doi: 10.4088/JCP.14m09416.

    PubMed 25562685

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paliperidone palmitate in people with Schizoaffective Disorder, run by Janssen Scientific Affairs, LLC at 80 sites in 8 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 5 inclusion and 13 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 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, India, Ukraine, Romania, South Africa and 3 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. 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?

Yes. Results are posted in the registry (first posted 5 Jan 2015). 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?

Double-blind: Percentage of Participants Who Experienced Relapse (time frame: Day 1 up to Month 15 of double blind relapse prevention period). 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 NCT01193153, which also lists 2 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 5 Jan 2015.

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