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Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT01010750
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : February 25, 2011
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Attention-Deficit Hyperactivity Disorder
Interventions Drug: Lisdexamfetamine Dimesylate (LDX)
Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
Drug: LDX Placebo + MAS-IR Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.
Arm/Group Title LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
Period Title: First Intervention
Started 3 4 3 3 2 3
Completed 3 4 3 3 2 3
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention
Started 3 4 3 3 2 3
Completed 3 3 3 3 2 3
Not Completed 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0
Period Title: Third Intervention
Started 3 3 3 3 2 3
Completed 3 3 3 3 2 3
Not Completed 0 0 0 0 0 0
Arm/Group Title LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 3 4 3 3 2 3 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 3 participants 3 participants 2 participants 3 participants 18 participants
25.0  (1.00) 24.8  (6.70) 30.3  (6.11) 31.3  (11.37) 53.0  (0.00) 30.0  (11.36) 30.8  (10.75)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 3 participants 3 participants 2 participants 3 participants 18 participants
<18 years 0 0 0 0 0 0 0
Between 18 and 55 years 3 4 3 3 2 3 18
>=56 years 0 0 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 3 participants 3 participants 2 participants 3 participants 18 participants
Female
0
   0.0%
2
  50.0%
1
  33.3%
1
  33.3%
1
  50.0%
2
  66.7%
7
  38.9%
Male
3
 100.0%
2
  50.0%
2
  66.7%
2
  66.7%
1
  50.0%
1
  33.3%
11
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 3 participants 3 participants 2 participants 3 participants 18 participants
3 4 3 3 2 3 18
1.Primary Outcome
Title Power of Attention Score
Hide Description The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
Time Frame pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: milliseconds
half an hour prior to dosing 1260.7  (34.000) 1324.1  (47.142) 1272.8  (33.729)
1 hour post-dose 1244.6  (32.887) 1307.4  (42.908) 1253.1  (24.174)
2 hours post-dose 1315.5  (67.246) 1255.0  (33.905) 1296.2  (39.808)
3 hours post-dose 1219.1  (33.428) 1229.6  (37.865) 1301.0  (40.864)
4 hours post-dose 1225.9  (40.192) 1236.5  (36.839) 1275.4  (35.302)
5 hours post-dose 1179.6  (35.022) 1251.4  (42.607) 1330.3  (49.623)
8 hours post-dose 1212.0  (36.113) 1259.3  (35.883) 1304.5  (43.802)
12 hours post-dose 1232.4  (48.183) 1239.3  (38.465) 1262.1  (40.795)
14 hours post-dose 1199.3  (35.947) 1270.1  (39.539) 1270.5  (44.814)
16 hours post-dose 1202.6  (37.135) 1255.9  (36.378) 1270.3  (48.581)
2.Secondary Outcome
Title Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems
Hide Description Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Time Frame 2 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PD
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: Units on a scale
2 hours post-dose 66.16  (2.927) 63.39  (3.319) 64.92  (2.775)
14 hours post-dose 65.78  (3.029) 64.45  (2.483) 66.33  (2.398)
3.Secondary Outcome
Title CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness
Hide Description Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Time Frame 2 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PD
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: Units on a scale
2 hours post-dose 64.21  (2.996) 63.62  (3.372) 63.28  (3.063)
14 hours post-dose 65.08  (2.837) 63.41  (2.763) 65.74  (2.597)
4.Secondary Outcome
Title CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability
Hide Description Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Time Frame 2 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PD
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: Units on a scale
2 hours post-dose 55.46  (2.931) 54.58  (3.470) 54.66  (3.421)
14 hours post-dose 57.82  (3.479) 51.53  (2.802) 55.78  (2.773)
5.Secondary Outcome
Title CAARS-S:S Subscale T-Score: Problems With Self-Concept
Hide Description Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Time Frame 2 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PD
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: Units on a scale
2 hours post-dose 58.71  (3.533) 59.78  (3.390) 58.40  (3.279)
14 hours post-dose 59.68  (3.841) 59.54  (3.574) 59.68  (3.055)
6.Secondary Outcome
Title CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index
Hide Description Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Time Frame 2 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PD
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 17 17
Mean (Standard Error)
Unit of Measure: Units on a scale
2 hours post-dose 64.82  (3.147) 63.90  (3.766) 64.59  (3.681)
14 hours post-dose 66.56  (3.714) 63.09  (2.945) 64.85  (3.118)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
 
Arm/Group Title LDX 50 mg MAS-IR 20 mg Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
LDX 50 mg MAS-IR 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LDX 50 mg MAS-IR 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/17 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDX 50 mg MAS-IR 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/18 (66.67%)      9/17 (52.94%)      8/17 (47.06%)    
Cardiac disorders       
Palpitations  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0
Diarrhea  0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1
Dry Mouth  6/18 (33.33%)  8 4/17 (23.53%)  6 3/17 (17.65%)  3
Nausea  1/18 (5.56%)  1 1/17 (5.88%)  1 0/17 (0.00%)  0
General disorders       
Chest Pain  0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1
Fatigue  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Feeling Jittery  1/18 (5.56%)  1 2/17 (11.76%)  3 0/17 (0.00%)  0
Irritability  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Investigations       
Heart Rate Increased  2/18 (11.11%)  2 0/17 (0.00%)  0 0/17 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  3/18 (16.67%)  3 4/17 (23.53%)  5 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders       
Sensation of Heaviness  0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0
Nervous system disorders       
Dizziness  1/18 (5.56%)  1 1/17 (5.88%)  1 1/17 (5.88%)  1
Headache  1/18 (5.56%)  1 1/17 (5.88%)  1 3/17 (17.65%)  3
Paraesthesia  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Sedation  0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0
Psychiatric disorders       
Bruxism  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Insomnia  1/18 (5.56%)  1 1/17 (5.88%)  1 0/17 (0.00%)  0
Nervousness  0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0
Obsessive-Compulsive Disorder  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Renal and urinary disorders       
Dysuria  1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0
Micturition Disorder  1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1/18 (5.56%)  1 2/17 (11.76%)  2 0/17 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerald Tremblay, M.D.
Organization: Shire Pharmaceutical
EMail: gtremblay@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01010750     History of Changes
Other Study ID Numbers: SPD489-115
First Submitted: November 9, 2009
First Posted: November 10, 2009
Results First Submitted: January 7, 2011
Results First Posted: February 25, 2011
Last Update Posted: March 10, 2014