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Trial record 4 of 36 for:    fetal alcohol children

Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD (B4Z-US-050)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00418262
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Mark L. Wolraich
Information provided by (Responsible Party):
Laura J McGuinn, MD, University of Oklahoma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fetal Alcohol Syndrome
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention Drug: Atomoxetine
Enrollment 27
Recruitment Details The study the recruited 29 (21 male/8 female) children between 10/18/2006 and 9/21/2011. The children were recruited from a prior efficacy trial. Participants for the efficacy trial were drawn from physician referral resources, self-referral, and a pool of subjects identified for a study sponsored by the Center for Disease Control and Prevention.
Pre-assignment Details Two recruits declined particicpation in this open-label study. Participants continued to take atomoxetine/placeblo (depending on prior RCT assignment) until entry into this open label study.
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit.
Period Title: Visits 1 (Baseline) Thru 5
Started 27
Completed 25
Not Completed 2
Period Title: Visits 5 Thru 8
Started 25
Completed 16
Not Completed 9
Period Title: Visits 8 Thru 10
Started 16
Completed 11
Not Completed 5
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This “titration” will occur at each visit.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
27
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
7.4
(4.3 to 12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
8
  29.6%
Male
19
  70.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  11.1%
White
15
  55.6%
More than one race NA [1] 
Unknown or Not Reported
9
  33.3%
[1]
Not assessed
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Pittsburg Side-Effects Scale: Motor Tics
Hide Description

Motor Tics

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
Children with FAS participating in the extend safety efficacy study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.15  (0.54)
Visit 5 Number Analyzed 25 participants
0.20  (0.50)
Visit 8 Number Analyzed 16 participants
0.31  (0.60)
Visit 10 Number Analyzed 11 participants
0.27  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.21 to 0.30
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.42 to 0.60
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
2.Primary Outcome
Title Pittsburg Side-Effects Scale-Buccal, Lingual Movements
Hide Description

Buccal, Lingual Movements

Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
Attrition
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
.12  (.33)
Visit 5 Number Analyzed 25 participants
0.2  (0.50)
Visit 8 Number Analyzed 16 participants
0.44  (0.73)
Visit 10 Number Analyzed 11 participants
0.27  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.11 to 0.39
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.23 to 0.77
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
3.Primary Outcome
Title Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
Hide Description

Movements, Picking/Chewing Skin or Fingers

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
27 IN PCT and one subject did not enroll in the safety efficacy study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.42  (0.70)
Visit 5 Number Analyzed 25 participants
0.40  (0.58)
Visit 8 Number Analyzed 16 participants
0.62  (0.89)
Visit 10 Number Analyzed 11 participants
0.64  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.17 to 0.36
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.17 to 0.36
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
4.Primary Outcome
Title Pittsburg Side-Effects Scale: Worried/Anxious
Hide Description

Worried/Anxious

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject from RCT did not enroll in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:

Visit 1

One additional subject left the study

Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.27  (0.45)
Visit 5 Number Analyzed 25 participants
0.24  (0.60)
Visit 8 Number Analyzed 16 participants
0.56  (0.63)
Visit 10 Number Analyzed 11 participants
0.45  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.16 to 0.40
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.16 to 0.40
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
5.Primary Outcome
Title Pittsburg Side-Effects Scale: Dull/Tired/Listless
Hide Description

Dull/Tired/Listless

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject from the RCT did not enter the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
One additional subject left the study
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.31  (0.62)
Visit 5 Number Analyzed 25 participants
0.36  (0.57)
Visit 8 Number Analyzed 16 participants
0.38  (0.62)
Visit 10 Number Analyzed 11 participants
0.36  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.36 to 0.18
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.36 to 0.18
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
6.Primary Outcome
Title Pittsburg Side-Effects Scale: Headaches
Hide Description

Headaches

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject from the RCT did not enter the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.23  (0.51)
Visit 5 Number Analyzed 25 participants
0.40  (0.82)
Visit 8 Number Analyzed 16 participants
0.31  (0.60)
Visit 10 Number Analyzed 11 participants
0.18  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.20 to 0.35
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.20 to 0.35
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
7.Primary Outcome
Title Pittsburg Side-Effects Scale: Stomachaches
Hide Description

Stomachaches

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the RCT did not enroll in the Open Label Study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.23  (0.51)
Visit 5 Number Analyzed 25 participants
0.36  (0.49)
Visit 8 Number Analyzed 16 participants
0.25  (0.58)
Visit 10 Number Analyzed 11 participants
0.45  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.24 to 0.24
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.49 to 0.49
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
8.Primary Outcome
Title Pittsburg Side-Effects Scale: Crabby/Irritable
Hide Description

Crabby/Irritable

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One Subject in the RCT did not enroll in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:

Visit 1

One additional subject left the study

Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.85  (0.88)
Visit 5 Number Analyzed 25 participants
0.68  (0.85)
Visit 8 Number Analyzed 16 participants
1.06  (0.85)
Visit 10 Number Analyzed 11 participants
0.73  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.28 to 0.26
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.56 to 0.52
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
9.Primary Outcome
Title Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
Hide Description

Tearful/Sad/Depressed

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in RCT did not participate in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.19  (0.40)
Visit 5 Number Analyzed 25 participants
0.24  (0.52)
Visit 8 Number Analyzed 16 participants
0.50  (0.63)
Visit 10 Number Analyzed 11 participants
0.27  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.32 to 0.20
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.64 to 0.39
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
10.Primary Outcome
Title Pittsburg Side-Effects Scale: Socially Withdrawn
Hide Description

Socially Withdrawn

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the RCT did not enroll in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
One additional subject left the study
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.12  (0.43)
Visit 5 Number Analyzed 25 participants
0.16  (0.47)
Visit 8 Number Analyzed 16 participants
0.25  (0.58)
Visit 10 Number Analyzed 11 participants
0.09  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.28 to 0.24
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.57 to 0.47
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
11.Primary Outcome
Title Pittsburg Side-Effects Scale: Hallucinations
Hide Description

Hallucinations

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the RCT did not enroll in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
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Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.04  (0.20)
Visit 5 Number Analyzed 25 participants
0.00  (0.00)
Visit 8 Number Analyzed 16 participants
0.12  (0.50)
Visit 10 Number Analyzed 11 participants
0.00  (0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.21 to 0.32
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.21 to 0.32
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
12.Primary Outcome
Title Pittsburg Side-Effects Scale: Loss of Appetite
Hide Description

Loss of Appetite

Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the RCT did not enroll in the open label study
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.46  (.65)
Visit 5 Number Analyzed 25 participants
0.56  (0.65)
Visit 8 Number Analyzed 16 participants
0.38  (0.50)
Visit 10 Number Analyzed 11 participants
0.45  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.36 to 0.13
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.72 to 0.27
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
13.Primary Outcome
Title Pittsburg Side-Effects Scale: Trouble Sleeping
Hide Description Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.
Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject participating in the RCT did not participate in the open label
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
0.35  (0.57)
Visit 5 Number Analyzed 25 participants
0.64  (0.70)
Visit 8 Number Analyzed 16 participants
0.53  (0.74)
Visit 10 Number Analyzed 11 participants
0.40  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.19 to 0.35
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.19 to 0.35
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
14.Secondary Outcome
Title Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
Hide Description Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.
Time Frame 12 months or study duration
Hide Outcome Measure Data
Hide Analysis Population Description
ADHD Parent Rating Scale
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description:
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Overall Number of Participants Analyzed 26
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Visit 1 Number Analyzed 26 participants
37.35
(32.64 to 42.35)
Visit 8 Number Analyzed 16 participants
27.87
(23.52 to 32.26)
Visit 10 Number Analyzed 26 participants
31.88
(24.94 to 38.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.40
Confidence Interval (2-Sided) 95%
-7.76 to -7.04
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.44
Confidence Interval (2-Sided) 95%
-3.03 to -1.90
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
15.Secondary Outcome
Title Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
Hide Description Height measured in centimeters at the time of each visit as part of the vital signs.
Time Frame 12 months or study duration
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Hide Analysis Population Description
Measurements of height were not consistently obtained on all subjects.
Arm/Group Title Atomoxetine HCL (Strattera)
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Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)

atomoxetine hydrochloride: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.

Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: cm
Visit 1 Number Analyzed 23 participants
121.67  (9.84)
Visit 8 Number Analyzed 3 participants
123.27  (4.01)
Visit 10 Number Analyzed 7 participants
132.13  (8.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.69 to 1.38
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine HCL (Strattera)
Comments Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.69 to 1.38
Estimation Comments This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
Time Frame 1 year
Adverse Event Reporting Description All-Ccause Mortality and Serious Adverse Events were monitored.
 
Arm/Group Title Atomoxetine HCL (Strattera)
Hide Arm/Group Description The subjects received 7 days of atomoxetine at 0.5 mg/kg/day. The children were seen weekly for assessment for 4 weeks then every two weeks until the eight week double blind period was completed. After each week of treatment, response was reassessed and the dose was increased to 1.0 then 1.4 mg/kg/d unless there were excessive side effects. The subjects were then invited to continue for 1 year to assess safety and efficacy
All-Cause Mortality
Atomoxetine HCL (Strattera)
Affected / at Risk (%)
Total   0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine HCL (Strattera)
Affected / at Risk (%) # Events
Total   0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atomoxetine HCL (Strattera)
Affected / at Risk (%) # Events
Total   19/26 (73.08%)    
Ear and labyrinth disorders   
Ear Infection  [1]  3/26 (11.54%)  204
Gastrointestinal disorders   
Vomiting  [2]  8/26 (30.77%)  204
Stomachache  [3]  7/26 (26.92%)  204
Diarrhea  [4]  3/26 (11.54%)  204
Decreased Appetite  [5]  2/26 (7.69%)  204
General disorders   
Nasal Congestion or Rhinorrhea  [6]  6/26 (23.08%)  204
Fever  [7]  4/26 (15.38%)  204
Dizziness  [8]  3/26 (11.54%)  204
Fatigue  [9]  2/26 (7.69%)  204
Infections and infestations   
Upper Respiratory or Sinus Infection  [10]  4/26 (15.38%)  204
Sore Throat  [11]  2/26 (7.69%)  204
Nervous system disorders   
Headache  [12]  8/26 (30.77%)  204
Sleepy or Sleep Trouble  [13]  7/26 (26.92%)  204
Psychiatric disorders   
Irritability  [14]  4/26 (15.38%)  204
Sad and Angry or Mood Swings  [15]  2/26 (7.69%)  204
Renal and urinary disorders   
Enuresis  [16]  4/26 (15.38%)  204
Respiratory, thoracic and mediastinal disorders   
Cough  [17]  9/26 (34.62%)  204
Asthma or Wheezing  [18]  2/26 (7.69%)  204
Skin and subcutaneous tissue disorders   
Skin Rash or Redness  [19]  2/26 (7.69%)  204
Indicates events were collected by systematic assessment
[1]
Ear Infection
[2]
Vomiting
[3]
Stomachache
[4]
Diarrhea
[5]
Decreased Appetite
[6]
Nasal Congestion or Rhinorrhea
[7]
Fever
[8]
Dizziness
[9]
Fatigue
[10]
Upper Respiratory or Sinus Infection
[11]
Sore Throat
[12]
Headache
[13]
Sleepy or Sleep Trouble
[14]
Irritability
[15]
Sad and Angry or Mood Swings
[16]
Enuresis
[17]
Cough
[18]
Asthma or Wheezing
[19]
Skin Rash or Redness
There were a limited number of subjects because of difficulties in recruiting children with FAS and ADHD within the age group studied. We were only able to obtain a small number of teacher rating scales.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark Wolraich, M.D.
Organization: University of Oklahoma Health Sciences Center
Phone: (405) 271-5700 ext 45123
Responsible Party: Laura J McGuinn, MD, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00418262     History of Changes
Other Study ID Numbers: 2112
First Submitted: January 2, 2007
First Posted: January 4, 2007
Results First Submitted: June 2, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017