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

NCT ID: NCT00784654

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-27
• Study Completion Date: 2011-10-26

Brief 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

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lisdexamfetamine dimesylate (LDX)

Open-label 30, 50, or 70mg

Group Type: EXPERIMENTAL

Lisdexamfetamine dimesylate (LDX)

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule once per day (double-blind period)

Interventions

Lisdexamfetamine dimesylate (LDX)

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

Intervention Type: DRUG

Placebo

Placebo capsule once per day (double-blind period)

Intervention Type: DRUG

Other Intervention Names

Vyvanse, SPD489

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Subject is a male or female aged 6-17 years inclusive at the time of consent for the antecedent study (SPD489-325).

4. 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.

5. 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.

6. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria

1. Subject was terminated from SPD489-325 for non-compliance and/or experienced an SAE or AE resulting in termination from the antecedent study.

2. 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).

3. Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.

4. 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.

5. 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.

6. Subject is female and is pregnant or lactating.

7. Subject has glaucoma.

8. 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).

9. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine.

10. 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.

11. 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.

12. 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.

13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

14. Subject is taking any medication that is excluded.

15. 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.

16. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational medicinal product(s).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Peninsula Research Associates, Inc.

Rolling Hills Estates, California, United States

Miami Research Associates

South Miami, Florida, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

CNS Healthcare

Memphis, Tennessee, United States

ZNA Antwerpen, Commandant Weynsstraat 165

Hoboken, Antwerpen, Belgium

Afdeling Psychiatrie, UZ Herestraat 49

Leuven, Flemish Brabant, Belgium

Universitair Ziekenhuis Gent, Kinder - en Jeugdpsychiatrie

Ghent, Oost-vlaanderen, Belgium

Hôpital Gui de Chauliac

Montpellier, , France

Hospital Archet 2

Nice, , France

Hôpital Robert Debré

Paris, Île-de-France Region, France

Albert-Ludwigs-Universitat Freiburg

Freiburg im Breisgau, Baden-wuttemberg, Germany

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Baden-wuttemberg, Germany

Schwerpunktpraxis für Entwicklung und Lernen

Bamberg, Bavaria, Germany

Medizinisches Studienzentrum Würzburg

Würzburg, Bavaria, Germany

Universität Würzburg

Würzburg, Bavaria, Germany

Institutsambulanz Bad Nauheim

Bad Nauheim, Hesse, Germany

Universitat Göttingen

Göttingen, Lower Saxony, Germany

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

Cologne, North Rhine-Westphalia, Germany

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsmedizin Berlin

Berlin, , Germany

Praxis Dr. Walter Robert Otto

Fulda, , Germany

Praxis Dr. Wolff

Hagen, , Germany

Praxis für Neuropädiatrie

Hamburg, , Germany

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

Hamburg, , Germany

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

Marburg, , Germany

Vadaskert Kórház és Szakambulancia

Budapest, , Hungary

Pándy Kálmán Kórház

Gyula, , Hungary

Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

Pécs, , Hungary

Szegedi Tudományegyetem

Szeged, , Hungary

Azienda Ospedaliera Policlinico Consorziale

Bari, , Italy

Università degli Studi di Cagliari

Cagliari, , Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, , Italy

Azienda Ospedaliera della 2? Universita di Napoli

Napoli, , Italy

Specjalistyczna Praktyka Lekarska

Poznan, Greater Poland Voivodeship, Poland

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Wojewódzki Osrodek Lecznictwa Psychiatrycznego

Torun, Kuyavian-Pomeranian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Gdanski Uniwersytet Medyczna w Gdansku

Gdansk, Pomeranian Voivodeship, Poland

Drottning Silvias Barnsjukhus, Otterhällegatan 12A

Gothenburg, , Sweden

Utvecklingsneurologiska Enheten (UNE)

Mariestad, , Sweden

Astrid Lindgren Children's Hospital, Karolinska University Hospital

Stockholm, , Sweden

Barn och Ungdomsmedicin klinik Mölnlycke

Stockholm, , Sweden

Parkview Clinic

Birmingham, England, United Kingdom

East Kent NHS and Social Care Partnership Trust

Ramsgate, England, United Kingdom

Lighthouse Child Development Centre

Southend-on-Sea, Essex, United Kingdom

Victoria Hospital, Paediatric Unit

Kirkcaldy, FIFE, United Kingdom

Tayside Children's Hospital

Dundee, Scotland, United Kingdom

Ryegate Children's Centre

Sheffield, Yorkshire, United Kingdom

Basildon Hospital - Child Development Centre,

Basildon, , United Kingdom

Northampton Child and Adolescent Mental Health Services

Northampton, , United Kingdom

Child and Family Mental Health Services

Wigan, , United Kingdom

Countries

United States; Belgium; France; Germany; Hungary; Italy; Poland; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 25139785 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24839883 (View on PubMed)

Other Identifiers

2008-000720-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD489-326

Identifier Type: -

Identifier Source: org_study_id