Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT01328756
Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study testing Lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 35 sites in 10 countries.
Trial summary
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Lisdexamfetamine dimesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 35 sitesin 10 countries
- Study dates
- 7 Jul 2011to 30 Sep 2014
- Phase
- Phase 4
- 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
- For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):
- Subject is a male or female aged 6-17 years.
- Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1 week post-treatment safety follow-up visit.
- For subjects who have not participated in another SPD489 study:
- Subject is a male or female aged 6-17 years.
- Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
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- For all subjects:
- Subject has a Baseline ADHD-RS-IV total score greater than or equal to 28.
- Subject, who is female of childbearing potential (FOCP), must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test, and a negative urine pregnancy test at Baseline, be non-lactating and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject and parent/LAR are willing and able to comply with all the testing and requirements defined, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00 AM, to dispense the dose of Investigational Product for the duration of the study.
- Subject aged greater than or equal to 18 years has a systolic blood pressure less than or equal to 139 mmHg and a diastolic blood pressure less than or equal to 89 mmHg.
- Subject is able to swallow a capsule.
Who cannot join
- For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):
- Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for protocol non-adherence and/or subject non-compliance and/or experienced a medication-related SAE or AE resulting in termination from the previous study.
- Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489 317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would preclude further exposure to SPD489.
- For all subjects:
- Subject's symptoms are well-controlled on their currently prescribed ADHD medication with acceptable tolerability.
- Subject has a positive urine drug result at Screening.
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- 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 (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension.
- Subject has taken another Investigational Product or taken part in a clinical study with the exception of a prior SPD489 study (SPD489-317, SPD489 325, or SPD489 326) within 30 days prior to Screening.
- Subject weighs less than 22.7 kg (50 lbs).
- Subject is significantly overweight.
- Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.
- Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject.
- Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
- Subject has glaucoma.
- Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
- Subject has any clinically significant ECG abnormality.
- Subject has any clinically significant laboratory abnormalities.
- Subject has a documented allergy, hypersensitivity, or intolerance to any active ingredient or excipients in SPD489.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
- Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis of Tourette's Disorder, or a known family history of Tourette's Disorder. Subject has a history of tics that is judged by the Investigator to be exclusionary.
- Subject has a known history of symptomatic cardiovascular or cerebrovascular disease, advanced 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 has a medical condition, other than ADHD, that requires treatment with medications that have central nervous system effects and/or affect performance. Stable use of anticholinergic or theophylline bronchodilators is not exclusionary.
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
Spain8 sites
Complejo Hospitalario Universitario de Badajoz
Badajoz, 06010
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036
Hospital Sant Joan de Deu, Servicio de Psiquiatria Infantil Passeig Sant Joan de Deu, 2 Esplugues de Llobregat
Esplugues de Llobregat, Barcelona, 08950
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Clinica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatria y Psicologia Medica Avenida Pio XII 36 Apartado 4209 Pamplona
Pamplona, Navarre, 31008
Hospital Univeritario de Canarias, Consultas Externas de Psiquiatria Ofra l La Cuesta s/n San Cristobal de la Laguna Laguna Santa Cruz
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320
Mutua de Terrassa, Centro de Salud Mental Cap Rambla Psiquiatria Infantil Placa Doctor Robert, 5
Terrassa, Barcelona, 08221
Hospital Maritimo de Torremolinos
Torremolinos, Malaga, 29620
Germany7 sites
Schwerpunktpraxis für Entwicklung und Lernen
Bamberg, Bavaria, 96047
Universitätsmedizin Berlin
Berlin, 13353
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104
Praxis Dr.Christian Wolff
Hagen, North Rhine-Westphalia, 58093
Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
Hamburg, 22415
Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, Baden-Wurttemberg, 68159
Medizinisches Studienzentrum Würzburg
Würzburg, Bavaria, 97070
Hungary4 sites
Vadaskert Korhaz es Szakambulancia, Gyermek es Ifjusagpszichiatria Huvosvolgyi ut 116
Budapest, H-1021
Pandy Kalman Korhaz, Gyermekpszichiatria Semmelweis u.1.
Gyula, H-5700
Gyermek es Ifjusagpszichiatriai Szakrendeles es Gondozo Veress E. u. 2.
Pécs, Baranya, H-7633
Szegedi Tudomanyegyetem, Gyermek- es Ifjusagpszichiatriai Osztaly Boldogasszony sgt. 15
Szeged, Csongrád megye, H-6720
Poland3 sites
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
Wojewodzki Osrodek Lecznictwa Psychiatrycznego W Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, Masovian Voivodeship, 00-576
Romania3 sites
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
Bucharest, 41914
Spitalul Clinic de Psihiatrie Socola
Iași
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"
Timișoara, Timiș County, 300011
Sweden3 sites
Child Neuropsychiatry Centre The Queen Silvia Children's Hospita Otterhallegatan 12A
Gothenburg, 41118
Barn och Ungdomsmedicin klinik Molnlycke Ekdalavagen 2 Box 9
Mölnlycke, 43530
Paediatric Neurology Children's Hospital in Huddinge
Stockholm, 14186
Belgium2 sites
ZNA Antwerpen, Commandant Weynsstraat 165 Campus Hoge Beuken
Hoboken, Antwerp, 2660
Afdeling Psychiatrie
Leuven, B-3000
Italy2 sites
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, 09124
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125
United Kingdom2 sites
University of Dundee, Centre for Child Health 19 Dudhope Terrace Scotland
Dundee, Scotland, DD3 6HH
Thurrock Hospital
Grays, England, RM16 2PX
Netherlands1 site
Academisch Ziekenhuis Maastricht
Heerlen, Limburg, 6419XZ
About this study
Official title: A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.
A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.
Read more
In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.
Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.
- Being tested
- Lisdexamfetamine dimesylate
- 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, SPD489, LDX
Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine Dimesylate | Experimental | Not described Receives: Drug: Lisdexamfetamine dimesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Measured: Baseline up to 3 days after the last dose of study treatment (up to 2 years)
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Height at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
BMI was calculated as (weight [kilogram] per height [square meter]).
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
Measured: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
Measured: Baseline (Week 0), LOTA (Week 104)
Secondary outcomes (3)
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
Measured: Baseline (Week 0), LOTA (Week 104)
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.
Measured: LOTA (Week 104)
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Measured: LOTA (Week 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study start7 Jul 2011
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
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 Disorder (ADHD)Studies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 314 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
- NCT01328756
- Sponsor's protocol ID
- SPD489-404
- Other IDs
- 2010-020951-30
- Status last verified
- May 2021
- First submitted
- 29 Mar 2011
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Banaschewski T, Johnson M, Nagy P, Otero IH, Soutullo CA, Yan B, Zuddas A, Coghill DR. Growth and Puberty in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2018 May;32(5):455-467. doi: 10.1007/s40263-018-0514-8.
PubMed 29790103Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive Function of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate. CNS Drugs. 2018 Jan;32(1):85-95. doi: 10.1007/s40263-017-0487-z.
PubMed 29383572Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B, Caballero B, Zuddas A. Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe. CNS Drugs. 2017 Jul;31(7):625-638. doi: 10.1007/s40263-017-0443-y.
PubMed 28667569
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01328756
- Acronym / sponsor ID
- SPD489-404
- Keywords
- ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2011 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Posted 6 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.
A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.
In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.
Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine Dimesylate | Experimental | Drug: Lisdexamfetamine dimesylate |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):
- Subject is a male or female aged 6-17 years.
- Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1 week post-treatment safety follow-up visit.
- Subject is a male or female aged 6-17 years.
- Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
Key exclusion criteria (23 listed)
- For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):
- Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for protocol non-adherence and/or subject non-compliance and/or experienced a medication-related SAE or AE resulting in termination from the previous study.
- Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489 317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would preclude further exposure to SPD489.
- Subject's symptoms are well-controlled on their currently prescribed ADHD medication with acceptable tolerability.
- Subject has a positive urine drug result at Screening.
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: Vyvanse, SPD489, LDXOptimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years | Drug | Lisdexamfetamine Dimesylate |
Primary outcome
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Baseline up to 3 days after the last dose of study treatment (up to 2 years)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Height at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
BMI was calculated as (weight [kilogram] per height [square meter]).
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
3 secondary outcomes
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Time frame: LOTA (Week 104)
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Time frame: LOTA (Week 104)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29790103Banaschewski T, Johnson M, Nagy P, Otero IH, Soutullo CA, Yan B, Zuddas A, Coghill DR. Growth and Puberty in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2018 May;32(5):455-467. doi: 10.1007/s40263-018-0514-8.
- Derived from this study: PubMed 29383572Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive Function of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate. CNS Drugs. 2018 Jan;32(1):85-95. doi: 10.1007/s40263-017-0487-z.
- Derived from this study: PubMed 28667569Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B, Caballero B, Zuddas A. Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe. CNS Drugs. 2017 Jul;31(7):625-638. doi: 10.1007/s40263-017-0443-y.
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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
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 35 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 12 inclusion and 23 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 10 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 35 sites in Spain, Germany, Hungary, Poland, Romania 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Aug 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?
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs (time frame: Baseline up to 3 days after the last dose of study treatment (up to 2 years)). The study lists 11 primary outcomes in all. 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 NCT01328756, 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 10 Jun 2021.