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ADHDPhase 3NCT00784654

Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

A Phase 3 study testing Lisdexamfetamine dimesylate (LDX) in people with ADHD, run by Shire at 51 sites in 9 countries.

Completed

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

Official record
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Trial summary

The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months 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)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
51 sitesin 9 countries
Study dates
27 Jan 2009to 26 Oct 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's parent or legally authorised representative(LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study-related procedures.
  • Subject and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of test product for the duration of the study.
  • Subject is a male or female aged 6-17 years inclusive at the time of consent for the antecedent study (SPD489-325).
  • Subject satisfied all entry criteria for the antecedent study (SPD489-325), and completed a minimum of 4 weeks of double-blind treatment, reached Visit 4 and completed the 1-week post-treatment washout in the antecedent study (SPD489-325), without experiencing any clinically significant AEs that would preclude exposure to LDX.
  • Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination findings and clinical laboratory test results.
  • Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Who cannot join

  • Subject was terminated from SPD489-325 for non-compliance and/or experienced an SAE or AE resulting in termination from the antecedent study.
  • 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 that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1)of the antecedent study (SPD489-325)with the Screening interview of the Kiddie-SADS-Present and Lifetime-Diagnostic Interview (K-SADS-PL)and additional modules if warranted by the results of the initial interview. Participation in behavioural therapy is permitted provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-325).
  • Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.
  • Subject has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
  • 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 is female and is pregnant or lactating.
Show all 16Show fewer
  • Subject has glaucoma.
  • Subject has any clinically significant ECG at Visit 8 of the antecedent study (SPD489-325) or clinically significant laboratory abnormalities at Visit 7 of the antecedent study (SPD489-325).
  • Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine.
  • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine)in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)criteria.
  • Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, a current diagnosis and or a known family history of Tourette's Disorder.
  • Subject has a known history of symptomatic cardiovascular 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 is taking any medication that is excluded.
  • Subject is taking other medications that have central nervous system (CNS) effects, affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of investigational medicinal product administration). Stable use of bronchodilator inhalers is not exclusionary.
  • Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational medicinal product(s).

Trial locations and contacts

51 sites in 9 countries.

51 sites in 9 countries

Germany15 sites

  • Institutsambulanz Bad Nauheim

    Bad Nauheim, Hesse, 61231

  • Schwerpunktpraxis für Entwicklung und Lernen

    Bamberg, Bavaria, 96047

  • Universitätsmedizin Berlin

    Berlin, 13353

  • Universität zu Köln, Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes und Jugendalters

    Cologne, North Rhine-Westphalia, 50931

  • Albert-Ludwigs-Universitat Freiburg

    Freiburg im Breisgau, Baden-wuttemberg, 79104

  • Praxis Dr. Walter Robert Otto

    Fulda, 36037

  • Universitat Göttingen

    Göttingen, Lower Saxony, 37075

  • Praxis Dr. Wolff

    Hagen, 58093

  • Praxis für Neuropädiatrie

    Hamburg, 22767

  • Praxis Dr med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

    Hamburg, D-22415

  • Klinikum der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Zentralinstitut für Seelische Gesundheit Mannheim

    Mannheim, Baden-wuttemberg, 68159

  • Universitätsklinikum Gießen und Marburg GmbH, Universitätsklinikum Gießen und Marburg GmbH, Hans-Sachs-Straße 4,

    Marburg, 35039

  • Medizinisches Studienzentrum Würzburg

    Würzburg, Bavaria, 97070

  • Universität Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

United Kingdom9 sites

  • Basildon Hospital - Child Development Centre,

    Basildon, SS16 5NL

  • Parkview Clinic

    Birmingham, England, B13 8QE

  • Tayside Children's Hospital

    Dundee, Scotland, DD1 9SY

  • Victoria Hospital, Paediatric Unit

    Kirkcaldy, FIFE, KY2 5AH

  • Northampton Child and Adolescent Mental Health Services

    Northampton, NN1 2BG

  • East Kent NHS and Social Care Partnership Trust

    Ramsgate, England, CT11 9DH

  • Ryegate Children's Centre

    Sheffield, Yorkshire, S10 5DD

  • Lighthouse Child Development Centre

    Southend-on-Sea, Essex, SS2 6XT

  • Child and Family Mental Health Services

    Wigan, WN2 2JA

Other trials in United Kingdom

Poland5 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

  • Specjalistyczna Praktyka Lekarska

    Poznan, Greater Poland Voivodeship, 60-792

  • Wojewódzki Osrodek Lecznictwa Psychiatrycznego

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Poradnia Psychiatryczna, ul. Marszalkowska 24,

    Warsaw, Masovian Voivodeship, 00-576

Other trials in Poland

United States4 sites

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 23112

  • Peninsula Research Associates, Inc.

    Rolling Hills Estates, California, 66212

  • Miami Research Associates

    South Miami, Florida, 47802

Other trials in United States

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

Other trials in Hungary

Italy4 sites

  • Azienda Ospedaliera Policlinico Consorziale

    Bari, 70124

  • Università degli Studi di Cagliari

    Cagliari, 9124

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98125

  • Azienda Ospedaliera della 2? Universita di Napoli

    Naples, 80131

Other trials in Italy

Sweden4 sites

  • Drottning Silvias Barnsjukhus, Otterhällegatan 12A

    Gothenburg, 41119

  • Utvecklingsneurologiska Enheten (UNE)

    Mariestad, 542 24

  • Astrid Lindgren Children's Hospital, Karolinska University Hospital

    Stockholm, 171 76

  • Barn och Ungdomsmedicin klinik Mölnlycke

    Stockholm, 435 30

Other trials in Sweden

Belgium3 sites

  • Universitair Ziekenhuis Gent, Kinder - en Jeugdpsychiatrie

    Ghent, Oost-vlaanderen, 9000

  • ZNA Antwerpen, Commandant Weynsstraat 165

    Hoboken, Antwerpen, 2660

  • Afdeling Psychiatrie, UZ Herestraat 49

    Leuven, Flemish Brabant, B-3000

Other trials in Belgium

France3 sites

  • Hôpital Gui de Chauliac

    Montpellier, 34295

  • Hospital Archet 2

    Nice, 06202

  • Hôpital Robert Debré

    Paris, Île-de-France Region, 75019

Other trials in France

About this study

Official title: A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, 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 evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months

Conditions
ADHD
Being tested
Lisdexamfetamine dimesylate (LDX), 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, SPD489

    LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

  • PlaceboDrug

    Placebo capsule once per day (double-blind period)

Study groups in NCT00784654
Study groupRoleWhat they receive
Lisdexamfetamine dimesylate (LDX)ExperimentalOpen-label 30, 50, or 70mg
Receives: Drug: Lisdexamfetamine dimesylate (LDX)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period

    Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures.

    Measured: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

Secondary outcomes (13)

  1. Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period

    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: Open-label baseline and Endpoint (Week-26)

  2. Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period

    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 of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

  3. Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period

    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

    Measured: At Week 26

  4. Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)

    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

    Measured: At endpoint of the randomized withdrawal period (Up to 6 weeks)

  5. Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period

    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. Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories.

    Measured: At Week 26

  6. Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF

    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: At open-label baseline and endpoint (Week-26) of the open-label period

  7. Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period

    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 of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

  8. Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period

    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: At open-label baseline and endpoint (Week-26) of the open-label period

  9. Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period

    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 of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

  10. Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period

    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: At open-label baseline and endpoint (Week-26) of the open-label period

  11. Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period

    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 of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

  12. Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period

    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: At open-label baseline and endpoint (Week-26) of the open-label period

  13. Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period

    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 of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

Timeline

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

  1. First posted4 Nov 2008 (estimated)
  2. Study start27 Jan 2009
  3. Primary completion26 Oct 2011
  4. Study completion26 Oct 2011

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00784654
Sponsor's protocol ID
SPD489-326
Other IDs
2008-000720-10, 2008
Status last verified
May 2021
First submitted
3 Nov 2008
Last updated
9 Jun 2021

Publications

  • Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, Squires LA, Coghill DR. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014 Dec;28(12):1191-203. doi: 10.1007/s40263-014-0193-z.

    PubMed 25139785

  • Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS, Civil R, Dauphin M, Higgins N, Lyne A, Gasior M, Squires LA. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):647-657.e1. doi: 10.1016/j.jaac.2014.01.017. Epub 2014 Mar 4.

    PubMed 24839883

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lisdexamfetamine dimesylate (LDX) in people with ADHD, run by Shire at 51 sites in 9 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 6 inclusion and 16 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 9 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 51 sites in Germany, United Kingdom, Poland, United States, Hungary and 4 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 2 Oct 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?

Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period (time frame: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 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 NCT00784654, 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 9 Jun 2021.

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