Trial Outcomes & Findings for Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD (NCT NCT01985581)
NCT ID: NCT01985581
Last Updated: 2016-05-23
Results Overview
The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.
COMPLETED
PHASE4
50 participants
measured at baseline and end of each 12 week treament arm
2016-05-23
Participant Flow
Subjects were recruited from principal investigators clinical practice as well as through advertisement in local medical offices and through print and radio advertisements
Participant milestones
| Measure |
Placebo First Then GXR
patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
|
GXR First Then Placebo
patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
22
|
23
|
|
First Intervention
NOT COMPLETED
|
3
|
2
|
|
Second Intervention
STARTED
|
22
|
23
|
|
Second Intervention
COMPLETED
|
20
|
19
|
|
Second Intervention
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
Baseline characteristics by cohort
| Measure |
PLB First Then GXR
n=25 Participants
subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
|
GXR First Then PLB
n=25 Participants
subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.0 years
n=5 Participants
|
10 years
n=7 Participants
|
9.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: measured at baseline and end of each 12 week treament armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2.
The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.
Outcome measures
| Measure |
Placebo and Stimulant
n=48 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=47 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires
|
-5.3 units on a scale
Standard Error 1.46
|
-6.9 units on a scale
Standard Error 1.53
|
SECONDARY outcome
Timeframe: Measured at baseline and end of each 12 week treatment armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child
Outcome measures
| Measure |
Placebo and Stimulant
n=47 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=46 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.
|
0.8 units on a scale
Standard Error 1.58
|
1.2 units on a scale
Standard Error 1.62
|
SECONDARY outcome
Timeframe: comparison from baseline to end of each 12 week treatment armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms
Outcome measures
| Measure |
Placebo and Stimulant
n=48 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=47 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)
|
-5.5 units on a scale
Standard Error 1.63
|
-11.1 units on a scale
Standard Error 1.51
|
SECONDARY outcome
Timeframe: Measured up to 30 weeksPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm
Outcome measures
| Measure |
Placebo and Stimulant
n=50 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=50 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm
|
1 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: Measured at baseline and end of each 12 week treatment armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.
Outcome measures
| Measure |
Placebo and Stimulant
n=48 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=47 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.
|
3.4 units on a scale
Standard Error 1.46
|
1.4 units on a scale
Standard Error 1.45
|
SECONDARY outcome
Timeframe: comparison from baseline to end of each 12 week treatment armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement
Outcome measures
| Measure |
Placebo and Stimulant
n=48 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=47 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale
|
10.6 percentage of subjects
|
29.8 percentage of subjects
|
SECONDARY outcome
Timeframe: comparison from baseline to end of each 12 week treatment armPopulation: ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.
CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement
Outcome measures
| Measure |
Placebo and Stimulant
n=48 Participants
Subjects received placebo and usual stimulant therapy
|
GXR and Stimulant
n=47 Participants
Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
|
|---|---|---|
|
Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale
|
27.7 percentage of subjects
|
57.4 percentage of subjects
|
Adverse Events
Stimulant and GXR
Stimulant and PLB
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stimulant and GXR
n=47 participants at risk
adverse event frequency in those taking stimulant + GXR
|
Stimulant and PLB
n=48 participants at risk
adverse event frequency in those taking stimulant + PLB
|
|---|---|---|
|
Nervous system disorders
Headache
|
48.9%
23/47 • from time consent was signed until end of study (week 30)
|
33.3%
16/48 • from time consent was signed until end of study (week 30)
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
25.5%
12/47 • from time consent was signed until end of study (week 30)
|
37.5%
18/48 • from time consent was signed until end of study (week 30)
|
|
Gastrointestinal disorders
Abdominal Upper Pain
|
29.8%
14/47 • from time consent was signed until end of study (week 30)
|
10.4%
5/48 • from time consent was signed until end of study (week 30)
|
|
Nervous system disorders
Insomnia
|
10.6%
5/47 • from time consent was signed until end of study (week 30)
|
18.8%
9/48 • from time consent was signed until end of study (week 30)
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
5/47 • from time consent was signed until end of study (week 30)
|
16.7%
8/48 • from time consent was signed until end of study (week 30)
|
|
Nervous system disorders
Fatigue
|
23.4%
11/47 • from time consent was signed until end of study (week 30)
|
2.1%
1/48 • from time consent was signed until end of study (week 30)
|
|
Gastrointestinal disorders
Gastroenteritis
|
12.8%
6/47 • from time consent was signed until end of study (week 30)
|
10.4%
5/48 • from time consent was signed until end of study (week 30)
|
|
Psychiatric disorders
Affect Lability
|
12.8%
6/47 • from time consent was signed until end of study (week 30)
|
2.1%
1/48 • from time consent was signed until end of study (week 30)
|
|
Nervous system disorders
Somnolence
|
10.6%
5/47 • from time consent was signed until end of study (week 30)
|
4.2%
2/48 • from time consent was signed until end of study (week 30)
|
|
General disorders
Pyrexia
|
6.4%
3/47 • from time consent was signed until end of study (week 30)
|
6.2%
3/48 • from time consent was signed until end of study (week 30)
|
|
Gastrointestinal disorders
Nauseau
|
2.1%
1/47 • from time consent was signed until end of study (week 30)
|
8.3%
4/48 • from time consent was signed until end of study (week 30)
|
|
General disorders
Sleep disorder
|
6.4%
3/47 • from time consent was signed until end of study (week 30)
|
2.1%
1/48 • from time consent was signed until end of study (week 30)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place