Trial · NCT00784654
Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
NCT00784654, Phase 3, Completed, Shire; results first posted 2012-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17. Trials, record NCT00784654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784654
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
- NCT number
- NCT00784654
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Shire
- Conditions
- ADHD
- Interventions
- Lisdexamfetamine dimesylate (LDX), Placebo
- First posted
- 2008-11-04
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2008-000720-10
- Results first posted
- 2012-10-02
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | 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. |
| Secondary | 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 | Open-label baseline and Endpoint (Week-26) | 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. |
| Secondary | Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | 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. |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | At Week 26 | 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) |
| Secondary | Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF) | At endpoint of the randomized withdrawal period (Up to 6 weeks) | 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) |
| Secondary | Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period | At Week 26 | 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. |
| Secondary | Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF | At open-label baseline and endpoint (Week-26) of the open-label 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. |
| Secondary | Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. |
| Secondary | 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 | At open-label baseline and 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. |
| Secondary | Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period. | percentage of participants | NUMBER |
| SECONDARY | 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 | Open-label baseline and Endpoint (Week-26) | Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period. | Scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | At Week 26 | Open-label FAS | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent of Participants With CGI-S at Open-label Baseline | Open-label baseline | Open-label FAS | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF) | At endpoint of the randomized withdrawal period (Up to 6 weeks) | Randomized FAS | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period | At Week 26 | Open-label FAS | percentage of improved participants | NUMBER |
| SECONDARY | Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label FAS | scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | Scores on a scale | MEAN |
| SECONDARY | 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 | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label FAS | T-scores | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 15.8 | percentage of participants | ||
| Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period | Placebo (Randomized Period) | 67.5 | percentage of participants | ||
| 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 | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | -26.6 | Standard Deviation 11.39 | Scores on a scale | |
| Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 1.2 | Standard Error 1.09 | Scores on a scale | |
| Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period | Placebo (Randomized Period) | 13.8 | Standard Error 1.06 | Scores on a scale | |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | Normal, not at all ill | 39.9 | percentage of participants | |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | Borderline mentally ill | 46.5 | percentage of participants | |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | Mildly ill | 1.5 | percentage of participants | |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | Moderately ill | 6.6 | percentage of participants | |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | Markedly ill | 4.5 | percentage of participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Period (Non-Randomized) | STARTED | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 276 | |
| Open-Label Period (Non-Randomized) | STARTED | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0 | |
| Open-Label Period (Non-Randomized) | STARTED | Placebo (Randomized Period) | 0 | |
| Open-Label Period (Non-Randomized) | COMPLETED | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 165 | |
| Open-Label Period (Non-Randomized) | COMPLETED | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0 | |
| Open-Label Period (Non-Randomized) | COMPLETED | Placebo (Randomized Period) | 0 | |
| Open-Label Period (Non-Randomized) | NOT COMPLETED | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 111 | |
| Open-Label Period (Non-Randomized) | NOT COMPLETED | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0 | |
| Open-Label Period (Non-Randomized) | NOT COMPLETED | Placebo (Randomized Period) | 0 | |
| Randomized Withdrawal Period | STARTED | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events129
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 76 | 276 | 91 |
| other | Decreased appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 3 | 78 | 3 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo (Randomized Period) | 0 | 79 | 0 |
| other | Headache | Nervous system disorders | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 58 | 276 | 80 |
| other | Headache | Nervous system disorders | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 6 | 78 | 6 |
| other | Headache | Nervous system disorders | Placebo (Randomized Period) | 5 | 79 | 7 |
| other | Weight decreased | Investigations | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 46 | 276 | 60 |
| other | Weight decreased | Investigations | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 2 | 78 | 2 |
| other | Weight decreased | Investigations | Placebo (Randomized Period) | 1 | 79 | 1 |
| other | Nasopharyngitis | Infections and infestations | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 43 | 276 | 64 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | ||
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | ||
| Total, all-cause mortality | Placebo (Randomized Period) | ||
| Total, other adverse events | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 227 | 276 |
| Total, other adverse events | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 31 | 78 |
| Total, other adverse events | Placebo (Randomized Period) | 20 | 79 |
| Total, serious adverse events | Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 12 | 276 |
| Total, serious adverse events | Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0 | 78 |
| Total, serious adverse events | Placebo (Randomized Period) | 1 | 79 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00784654
GET https://conductscience.org/api/trials/v1/NCT00784654/results?page=2