Attention-Deficit/Hyperactivity DisorderPhase 3NCT01106430
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
A Phase 3 study testing Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 64 sites in 10 countries.
Trial summary
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 64 sitesin 10 countries
- Study dates
- 28 Jun 2010to 19 Jul 2012
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy.
- Subject is a male or female aged 6-17 years inclusive at the time of consent
- Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- Subject must have a baseline ADHD-RS-IV total score 28.
Who cannot join
- Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response
- In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms.
- Subject has previously been exposed to STRATTERA or to amphetamine therapy
- Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments.
- Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Trial locations and contacts
64 sites in 10 countries.
64 sites in 10 countries
United States34 sites
Future Search Clinical Trials
Austin, Texas, 78731
Shanti Clinical Trials
Colton, California, 92324
Harmonex Neuroscience Research, Inc
Dothan, Alabama, 36303
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, 27707
Innovis Health
Fargo, North Dakota, 58103
Sarkis Clinical Trials
Gainesville, Florida, 32607
Cyn3rgy Research
Gresham, Oregon, 97030
Amedica Research Institute, Inc.
Hialeah, Florida, 33013
Red Oak Psychiatry Association, PA
Houston, Texas, 77090
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319
Capstone Clinical Research
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
Western Clinical Investigations
Lubbock, Texas, 79423
Baber Psychiatric Associates
Naperville, Illinois, 60563
Louisianna Research Associates
New Orleans, Louisiana, 70114
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, INC
Orlando, Florida, 32806
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003
CRI Worldwide, LLC Kirkbride Division
Philadelphia, Pennsylvania, 19139
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Office of Marc Hertzman, MD, PC
Rockville, Maryland, 20852
Northwest Behavioral Research Center
Roswell, Georgia, 30076
Midwest Research Group/Saint Charles Psychiatric Associates
Saint Charles, Missouri, 63301
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Cerebral Research, LLC
San Antonio, Texas, 78247
Psychiatric Centers at San Diego Feighner Research
San Diego, California, 92108
Richmond Behavioral Associates
Staten Island, New York, 10312
Clinco
Terre Haute, Indiana, 47802
Children's Specialized Hospital
Toms River, New Jersey, 08755
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Elite Clinical Trials, Inc.
Wildomar, California, 92595
Germany6 sites
Schwerpunktpraxis für Entwicklung und Lernen
Bamberg, Bavaria, 96047
Klinikum Frankfurt/Oder
Frankfurt (Oder), Brandenburg, 15236
Albert-Ludwigs-Universitat Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104
Praxis Dr. Wolff
Hagen, North Rhine-Westphalia, 58093
Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, Baden-Wurttemberg, 68159
Medizinisches Studienzentrum Würzburg
Würzburg, Bavaria, 97070
Spain6 sites
Complejo Hospitalario Universitario de Badajoz
Badajoz, 6010
Hospital Clinic i Provincial de Barcelona
Barcelona, 8036
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 7198
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J
Torremolinos, Malaga, 29620
Canada5 sites
Child and Adolescent Centre
Edmonton, Alberta, T6H 1P7
Centre for Anxiety Attention Deficit and Trauma
Hamilton, Ontario, L8S 1B7
AK Karan Holdings, Ltd.
Oakville, Ontario, L6J 0B2
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
The Kids Clinic
Whitby, Ontario, L1N 8M7
Hungary4 sites
Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria
Budapest
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, 5700
Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo
Pécs
Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly
Szeged, Csongrád megye, 6720
Belgium2 sites
ZiekenhuisNetwerk Antwerpen
Hoboken, Antwerpen, 2660
Universitair Ziekenhuis Gasthuisberg
Leuven, Flemish Brabant, 3000
Poland2 sites
Katedra i Klinika Psychiatarii
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-096
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, Masovian Voivodeship, 00-576
Sweden2 sites
Drottning Silvias Barnsjukhus
Gothenburg, 411 18
Astrid Lindgren Children's Hospital/Karolinska University Hospital
Stockholm, 141 86
United Kingdom2 sites
Basildon Hospital
Basildon, Essex, SS16 5NL
Tayside Children's Hospital
Dundee, Scotland, DD1 9SY
About this study
Official title: A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Lisdexamfetamine Dimesylate, Atomoxetine Hydrochloride
- Keywords
- ADHD
- 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.
Lisdexamfetamine DimesylateDrug
Also called Vyvanse
Oral 30, 50, or 70mg once-daily for 9 weeks
Atomoxetine HydrochlorideDrug
Also called Strattera
Oral 10mg to 100mg once-daily for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine Dimesylate | Experimental | Not described Receives: Drug: Lisdexamfetamine Dimesylate |
| Atomoxetine Hydrochloride | Active comparator | Not described Receives: Drug: Atomoxetine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Response
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: 9 weeks
Secondary outcomes (7)
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: 9 weeks
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Measured: Baseline and 9 weeks
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and up to 9 weeks
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Measured: up to 9 weeks
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Measured: Baseline and up to 9 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Measured: 9 weeks
Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study start28 Jun 2010
- Primary completion19 Jul 2012
- Study completion19 Jul 2012
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 (3)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106430
- Sponsor's protocol ID
- SPD489-317
- Other IDs
- 2009-011745-94, 2009
- Status last verified
- May 2021
- First submitted
- 14 Apr 2010
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92. doi: 10.1007/s40263-013-0104-8.
PubMed 23959815Nagy P, Hage A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22.
PubMed 25999292Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9.
PubMed 25038977
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy
- ClinicalTrials.gov ID
- NCT01106430
- Acronym / sponsor ID
- SPD489-317
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2010 (actual)
- Primary completion
- 19 Jul 2012 (actual)
- Study completion
- 19 Jul 2012 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Posted 24 Jun 2013
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 how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine Dimesylate | Experimental | Drug: Lisdexamfetamine Dimesylate |
| Atomoxetine Hydrochloride | Active comparator | Drug: Atomoxetine Hydrochloride |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy.
- Subject is a male or female aged 6-17 years inclusive at the time of consent
- Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- Subject must have a baseline ADHD-RS-IV total score 28.
Key exclusion criteria (6 listed)
- Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response
- In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms.
- Subject has previously been exposed to STRATTERA or to amphetamine therapy
- Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments.
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 |
|---|---|---|
| Lisdexamfetamine DimesylateAlso: VyvanseOral 30, 50, or 70mg once-daily for 9 weeks | Drug | Lisdexamfetamine Dimesylate |
| Atomoxetine HydrochlorideAlso: StratteraOral 10mg to 100mg once-daily for 9 weeks | Drug | Atomoxetine Hydrochloride |
Primary outcome
Time to First Response
Time frame: 9 weeks
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
7 secondary outcomes
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
Time frame: 9 weeks
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
Time frame: Baseline and 9 weeks
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
Time frame: Baseline and up to 9 weeks
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
Time frame: up to 9 weeks
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
Time frame: Baseline and up to 9 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 9 weeks
Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23959815Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92. doi: 10.1007/s40263-013-0104-8.
- Derived from this study: PubMed 25999292Nagy P, Hage A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22.
- Derived from this study: PubMed 25038977Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9.
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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.
Study Director study director
Takeda
64 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 64 sites in 10 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 4 inclusion and 6 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Germany, Spain, Canada, Hungary and 5 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 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 24 Jun 2013). 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?
Time to First Response (time frame: 9 weeks). 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 NCT01106430, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.