Clinical Trial Results:
A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
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Summary
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EudraCT number |
2010-020951-30 |
Trial protocol |
GB NL BE ES SE PL DE HU IT |
Global end of trial date |
30 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Sep 2018
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First version publication date |
25 Apr 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SPD489-404
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01328756 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Shire Pharmaceutical Development Ltd.
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Sponsor organisation address |
Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom,
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Public contact |
Study Physician, Shire, 1866 8425335,
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Scientific contact |
Study Physician, Shire, 1866 8425335,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000553-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Sep 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70 milligram [mg]) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study [SPD489-317 {2009-011745-94}, SPD489-325 {2008-000679-90}, or SPD489-326 {2008-000720-10}]) diagnosed with moderate to severely symptomatic Attention-Deficit/Hyperactivity Disorder (ADHD).
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Protection of trial subjects |
This study was conducted in accordance with current applicable regulations, International Conference on Harmonisation (ICH) of Good Clinical Practice (GCP), the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Jul 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 14
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Country: Number of subjects enrolled |
Poland: 8
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Country: Number of subjects enrolled |
Romania: 11
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Country: Number of subjects enrolled |
Spain: 82
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Country: Number of subjects enrolled |
Sweden: 43
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Country: Number of subjects enrolled |
United Kingdom: 10
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Country: Number of subjects enrolled |
Belgium: 14
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Country: Number of subjects enrolled |
Germany: 52
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Country: Number of subjects enrolled |
Hungary: 63
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Country: Number of subjects enrolled |
Italy: 17
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Worldwide total number of subjects |
314
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EEA total number of subjects |
314
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
170
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Adolescents (12-17 years) |
140
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Adults (18-64 years) |
4
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Study SPD489-404 enrolled subjects from 3 antecedent studies (SPD489-317, SPD489-325, and SPD489-326), or directly enrolled. Of 348 subjects screened, 314 subjects were enrolled and treated. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
At optimization period,subjects initiated SPD489 at 30 mg and dose was titrated until acceptable response(30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement[CGI-I]score of 1 or 2 with tolerable side effects)was achieved.Maximum dose was 70 mg.Dose adjustments were done in dose maintenance period. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Lisdexamfetamine dimesylate | ||||||||||||||||||||
Arm description |
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Lisdexamfetamine dimesylate
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Investigational medicinal product code |
SPD489
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Other name |
Vyvanse,Venvanse, Elvanse, Tyvense
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
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Baseline characteristics reporting groups
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Reporting group title |
Lisdexamfetamine dimesylate
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Reporting group description |
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lisdexamfetamine dimesylate
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Reporting group description |
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. | ||
Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Safety population (N=314) was defined as all subjects who took at least 1 dose of Lisdexamfetamine dimesylate during this study.
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Subject analysis set title |
Full Analysis Set (FAS) population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Of 314 enrolled subjects, 299 subjects were included in the FAS (that is, took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment). One subject without post baseline efficacy data and 14 additional subjects from one site were excluded from the FAS.
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End point title |
Number of Subjects With all Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [1] | ||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment up to follow-up visit (Week 108).
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End point type |
Primary
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End point timeframe |
Baseline (Week 0) up to follow-up visit (Week 108).
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [2] - Safety population |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [4] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [6] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) [7] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [8] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) [9] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [10] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Height at Last On-treatment Assessment (LOTA) [11] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [12] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) [13] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [14] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) [15] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [16] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in QT interval at Last On-treatment Assessment (LOTA) [17] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [18] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA) [19] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [20] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Scores at Last On-treatment Assessment (LOTA) [21] | ||||||||
End point description |
The BPRS-C was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor subject 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.
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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| Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [22] - Safety population with subjects evaluable for this outcome |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA) | ||||||||
End point description |
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. Higher score indicated worse symptom.
Please find the statistical analysis in the attachment below.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), LOTA (Week 104)
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Attachments |
Statistical analysis_Secondary_ADHD-RS-IV Total Sc |
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| Notes [23] - FAS population |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | ||||||||||||||||||||
End point description |
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the subject’s 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.
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End point type |
Secondary
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End point timeframe |
LOTA (Week 104)
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| Notes [24] - FAS population |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Number of Subjects With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | ||||||||||||||||||||
End point description |
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the subject’s 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 subjects), evaluated by the Investigator.
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End point type |
Secondary
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End point timeframe |
LOTA (Week 104)
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| Notes [25] - FAS population |
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| No statistical analyses for this end point | |||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline (Week 0) up to follow-up (Week 108)
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Adverse event reporting additional description |
TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment up to follow-up visit (Week 108).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Lisdexamfetamine dimesylate
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Reporting group description |
Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Nov 2011 |
1. Emergency contact information was updated
2. Inclusion and exclusion criteria were updated primarily to simplify subject inclusion with regard to their involvement in previous SPD489 clinical studies
3. Subjects with age >=18 years, were included at screening and blood pressure criteria for subjects with >=18 years at study entry were added
4. Excluded subjects whose symptoms were well-controlled on their currently prescribed ADHD medication with acceptable tolerability
5. 12-lead ECG was added at Visit 4
6. Permitted use of oral corticosteroids was defined
7. Restriction for montelukast sodium widened to include all leukotriene antagonists
8. Ferritin was added to biochemistry panel
9. Growth sub-section was added in accordance with primary objective. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Since this study is an open-label trial, results should be interpreted with caution. | |||
