ADHDPhase 3NCT00763971
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
A Phase 3 study testing Lisdexamfetamine Dimesylate (LDX) and Methylphenidate Hydrochloride in people with ADHD, run by Shire at 49 sites in 10 countries.
Trial summary
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Lisdexamfetamine Dimesylate (LDX) and Methylphenidate Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 49 sitesin 10 countries
- Study dates
- 17 Nov 2008to 16 Mar 2011
- 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 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.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is able to swallow a capsule.
Who cannot join
- Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
- Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
- Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- Subject has glaucoma.
- Subject weighs less than 22.7kg (50lbs).
- Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
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- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
- Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
- Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
- Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject is well controlled on their current ADHD medication with acceptable tolerability.
- Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
Trial locations and contacts
49 sites in 10 countries.
49 sites in 10 countries
Germany13 sites
Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6
Bamberg, Bavaria, 96047
Universitätsmedizin Berlin
Berlin, 13353
Albert-Ludwigs-Universitat Freiburg
Freiburg im Breisgau, 79104
Praxis Dr. Walter Robert Otto
Fulda, 36037
Universitat Gottingen
Göttingen, Lower Saxony, 37075
Praxis Dr. Wolff
Hagen, 58093
Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
Hamburg, 22415
Praxis für Neuropädiatrie, Schomburgstrasse 120
Hamburg, 22767
Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,
Mainz, Rhineland-Palatinate, 55131
Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5
Mannheim, Baden Wuttemburg, 68159
Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4
Marburg, Hesse, 35039
Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10
Würzburg, Bavaria, 97070
Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie
Würzburg, Bavaria, 97080
Spain7 sites
Complejo Hospitalario Universitario de Badajoz
Badajoz, 6010
Mutua de Terrassa
Barcelona, 8221
Hospital Sant Joan de Dèu
Esplugues de Llobregat, Barcelona, 08950
Hospital Ramón y Cajal, Servicio de psiquiatría
Madrid, 28034
Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica
Pamplona, Navarre, 31080
Hospital Universitario de Canarias C/Ofra
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n
Torremolinos, Malaga, 29630
United Kingdom5 sites
Basildon Hospital, Child Developement Centre, Nethermayne
Basildon, Essex, SS16 5NL
Tayside Childrens Hospital, Clinical Research Facility, Level 4
Dundee, Scotland, DD1 9SY
Victoria Hospital, Paediatric Unit, Hayfield Road
Kirkcaldy, Fife, Scotland, KY2 5AH
Ryegate Children's Centre, Tapton Crescent Road
Sheffield, Yorkshire, S10 5DD
Lighthouse Child Development Centre, Snakes Lane
Southend-on-Sea, Essex, SS2 6XT
France4 sites
Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent
Bordeaux Cédex, 33076
Hôpital Gui de Chauliac, 80, avenue Augustin Fliche
Montpellier, 34295
Hospital Archet 2
Nice, Cedex 03, 6202
Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent
Paris, Île-de-France Region, 75019
Hungary4 sites
Vadaskert Kórház és Szakambulancia
Budapest, 1021
Pándy Kálmán Kórház
Gyula, 5700
Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó
Pécs, 7632
Szegedi Tudományegyetem
Szeged, 6750
Poland4 sites
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
Gdanski Uniwersytet Medyczna w Gdansku
Gdansk, Pomeranian Voivodeship, 80-282
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, Masovian Voivodeship, 00-576
Sweden4 sites
Drottning Silvias Barnsjukhus
Gothenburg, 41119
Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12
Mariestad, Vastergotland, 54224
Astrid Lindgren Children's Hospital, Karolinska University Hospital
Stockholm, 171 76
Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9
Stockholm, 435 30
Belgium3 sites
Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185
Ghent, East Flanders, 9000
ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken
Hoboken, Antwerp, 2660
Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003
Leuven, 3000
Italy3 sites
Università degli Studi di Cagliari, Dipartimento di Neuroscienze
Cagliari, 9124
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125
Azienda Ospedaliera della 2 Universita di Napoli
Naples, 80131
Netherlands2 sites
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX
Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10
Nijmegen, 6525 GC
About this study
Official title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
- Conditions
- ADHD
- Being tested
- Lisdexamfetamine Dimesylate (LDX), Methylphenidate Hydrochloride, Placebo
- 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 Dimesylate (LDX)Drug
Also called Vyvanse™
30, 50 or 70mg capsule once per day (Overencapsulated)
Methylphenidate HydrochlorideDrug
Also called Concerta®, OROS MPH
18, 36, or 54mg tablet one per day (Overencapsulated)
PlaceboDrug
Placebo capsule once per day (Overencapsulated)
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Experimental | Overencapsulated LDX 30, 50, or 70mg Receives: Drug: Lisdexamfetamine Dimesylate (LDX) |
| Methylphenidate Hydrochloride | Active comparator | Overencapsulated Concerta 18, 36, or 54mg Receives: Drug: Methylphenidate Hydrochloride |
| Placebo | Placebo comparator | Overencapsulated Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging 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 up to 7 weeks
Secondary outcomes (7)
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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: Up to 7 weeks
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Measured: Baseline and up to 7 weeks
Health Utilities Index-2 (HUI-2) Scores at up to 7 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: Baseline and up to 7 weeks
Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
Measured: Baseline and up to 7 weeks
Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 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 7 weeks
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 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 7 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study start17 Nov 2008
- Primary completion16 Mar 2011
- Study completion16 Mar 2011
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 (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
- 336 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
- NCT00763971
- Sponsor's protocol ID
- SPD489-325
- Other IDs
- 2008-000679-90, 2008
- Status last verified
- Jun 2021
- First submitted
- 30 Sep 2008
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.
PubMed 23332456Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.
PubMed 23708466Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.
PubMed 23893527Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.
PubMed 26409610
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00763971
- Acronym / sponsor ID
- SPD489-325
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 16 Mar 2011 (actual)
- Study completion
- 16 Mar 2011 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Experimental | Drug: Lisdexamfetamine Dimesylate (LDX)Overencapsulated LDX 30, 50, or 70mg |
| Methylphenidate Hydrochloride | Active comparator | Drug: Methylphenidate HydrochlorideOverencapsulated Concerta 18, 36, or 54mg |
| Placebo | Placebo comparator | Drug: PlaceboOverencapsulated Placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is able to swallow a capsule.
Key exclusion criteria (13 listed)
- Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
- Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
- Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- Subject has glaucoma.
- Subject weighs less than 22.7kg (50lbs).
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 Dimesylate (LDX)Also: Vyvanse™30, 50 or 70mg capsule once per day (Overencapsulated) | Drug | Lisdexamfetamine Dimesylate (LDX) |
| Methylphenidate HydrochlorideAlso: Concerta®, OROS MPH18, 36, or 54mg tablet one per day (Overencapsulated) | Drug | Methylphenidate Hydrochloride |
| PlaceboPlacebo capsule once per day (Overencapsulated) | Drug | Placebo |
Primary outcome
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging 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.
7 secondary outcomes
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Time frame: Up to 7 weeks
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks
Time frame: Baseline and up to 7 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23332456Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.
- Results publication: PubMed 23708466Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.
- Results publication: PubMed 23893527Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.
- Derived from this study: PubMed 26409610Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.
- FDA recal informationLink provided by the sponsor.
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Conduct Disorder
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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
49 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 (LDX) and Methylphenidate Hydrochloride in people with ADHD, run by Shire at 49 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 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 14 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 49 sites in Germany, Spain, United Kingdom, France, 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. 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 22 Mar 2012). 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?
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (time frame: Baseline and up to 7 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 NCT00763971, 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 14 Jun 2021.