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Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01457339
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : January 21, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition: Schizophrenia
Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo Capsule(s) for oral use taken once daily for 30 days
SPD489 (Lisdexamfetamine Dimesylate) Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).

Participant Flow for 6 periods

Period 1:   Period 1 (50 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   24 
COMPLETED   7   24 
NOT COMPLETED   0   0 

Period 2:   Period 2 (70 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   24 
COMPLETED   7   24 
NOT COMPLETED   0   0 

Period 3:   Period 3 (100 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   24 
COMPLETED   7   23 
NOT COMPLETED   0   1 
Adverse Event                0                1 

Period 4:   Period 4 (150 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   23 
COMPLETED   7   23 
NOT COMPLETED   0   0 

Period 5:   Period 5 (200 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   23 
COMPLETED   7   22 
NOT COMPLETED   0   1 
Met stopping criteria for PANSS score                0                1 

Period 6:   Period 6 (250 mg)
    Placebo   SPD489 (Lisdexamfetamine Dimesylate)
STARTED   7   22 
COMPLETED   6   21 
NOT COMPLETED   1   1 
Family Emergency                1                0 
Personal appointment                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo Capsule(s) for oral use taken once daily for 30 days
SPD489 (Lisdexamfetamine Dimesylate)(All Doses) Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Total Total of all reporting groups

Baseline Measures
   Placebo   SPD489 (Lisdexamfetamine Dimesylate)(All Doses)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   24   31 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   24   31 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (4.93)   46.4  (7.86)   47.1  (7.35) 
Gender 
[Units: Participants]
     
Female   1   5   6 
Male   6   19   25 
Region of Enrollment 
[Units: Participants]
     
United States   7   24   31 


  Outcome Measures

1.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg   [ Time Frame: Baseline and day 5 ]

2.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg   [ Time Frame: Baseline and day 5 ]

3.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg   [ Time Frame: Baseline and day 5 ]

4.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg   [ Time Frame: Baseline and day 5 ]

5.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg   [ Time Frame: Baseline and day 5 ]

6.  Primary:   Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg   [ Time Frame: Baseline and day 5 ]

7.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg   [ Time Frame: Baseline and day 5 ]

8.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg   [ Time Frame: Baseline and day 5 ]

9.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg   [ Time Frame: Baseline and day 5 ]

10.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg   [ Time Frame: Baseline and day 5 ]

11.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg   [ Time Frame: Baseline and day 5 ]

12.  Primary:   Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg   [ Time Frame: Baseline and day 5 ]

13.  Primary:   Change From Baseline in Pulse Rate at Day 5: 50 mg   [ Time Frame: Baseline and day 5 ]

14.  Primary:   Change From Baseline in Pulse Rate at Day 5: 70 mg   [ Time Frame: Baseline and day 5 ]

15.  Primary:   Change From Baseline in Pulse Rate at Day 5: 100 mg   [ Time Frame: Baseline and day 5 ]

16.  Primary:   Change From Baseline in Pulse Rate at Day 5: 150 mg   [ Time Frame: Baseline and day 5 ]

17.  Primary:   Change From Baseline in Pulse Rate at Day 5: 200 mg   [ Time Frame: Baseline and day 5 ]

18.  Primary:   Change From Baseline in Pulse Rate at Day 5: 250 mg   [ Time Frame: Baseline and day 5 ]

19.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

20.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

21.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

22.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

23.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

24.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

25.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

26.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

27.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

28.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

29.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

30.  Secondary:   Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg   [ Time Frame: Day 5 (12-hour sampling period post-dose) ]

31.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg   [ Time Frame: Baseline and Day 5 ]

32.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg   [ Time Frame: Baseline and Day 5 ]

33.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg   [ Time Frame: Baseline and Day 5 ]

34.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg   [ Time Frame: Baseline and Day 5 ]

35.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg   [ Time Frame: Baseline and Day 5 ]

36.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg   [ Time Frame: Baseline and Day 5 ]

37.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg   [ Time Frame: Baseline and Day 5 ]

38.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg   [ Time Frame: Baseline and Day 5 ]

39.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg   [ Time Frame: Baseline and Day 5 ]

40.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg   [ Time Frame: Baseline and Day 5 ]

41.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg   [ Time Frame: Baseline and Day 5 ]

42.  Secondary:   Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg   [ Time Frame: Baseline and Day 5 ]

43.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg   [ Time Frame: Baseline and Day 5 ]

44.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg   [ Time Frame: Baseline and Day 5 ]

45.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg   [ Time Frame: Baseline and Day 5 ]

46.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg   [ Time Frame: Baseline and Day 5 ]

47.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg   [ Time Frame: Baseline and Day 5 ]

48.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg   [ Time Frame: Baseline and Day 5 ]

49.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg   [ Time Frame: Baseline and Day 5 ]

50.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg   [ Time Frame: Baseline and Day 5 ]

51.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg   [ Time Frame: Baseline and Day 5 ]

52.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg   [ Time Frame: Baseline and Day 5 ]

53.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg   [ Time Frame: Baseline and Day 5 ]

54.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg   [ Time Frame: Baseline and Day 5 ]

55.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg   [ Time Frame: Baseline and Day 5 ]

56.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg   [ Time Frame: Baseline and Day 5 ]

57.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg   [ Time Frame: Baseline and Day 5 ]

58.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg   [ Time Frame: Baseline and Day 5 ]

59.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg   [ Time Frame: Baseline and Day 5 ]

60.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg   [ Time Frame: Baseline and Day 5 ]

61.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg   [ Time Frame: Baseline and Day 5 ]

62.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg   [ Time Frame: Baseline and Day 5 ]

63.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg   [ Time Frame: Baseline and Day 5 ]

64.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg   [ Time Frame: Baseline and Day 5 ]

65.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg   [ Time Frame: Baseline and Day 5 ]

66.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg   [ Time Frame: Baseline and Day 5 ]

67.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg   [ Time Frame: Baseline and Day 5 ]

68.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg   [ Time Frame: Baseline and Day 5 ]

69.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg   [ Time Frame: Baseline and Day 5 ]

70.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg   [ Time Frame: Baseline and Day 5 ]

71.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg   [ Time Frame: Baseline and Day 5 ]

72.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg   [ Time Frame: Baseline and Day 5 ]

73.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg   [ Time Frame: Baseline and Day 5 ]

74.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg   [ Time Frame: Baseline and Day 5 ]

75.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg   [ Time Frame: Baseline and Day 5 ]

76.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg   [ Time Frame: Baseline and Day 5 ]

77.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg   [ Time Frame: Baseline and Day 5 ]

78.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg   [ Time Frame: Baseline and Day 5 ]

79.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg   [ Time Frame: Baseline and Day 5 ]

80.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg   [ Time Frame: Baseline and Day 5 ]

81.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg   [ Time Frame: Baseline and Day 5 ]

82.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg   [ Time Frame: Baseline and Day 5 ]

83.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg   [ Time Frame: Baseline and Day 5 ]

84.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg   [ Time Frame: Baseline and Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: 1 866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01457339     History of Changes
Other Study ID Numbers: SPD489-119
First Submitted: October 19, 2011
First Posted: October 21, 2011
Results First Submitted: December 13, 2012
Results First Posted: January 21, 2013
Last Update Posted: March 23, 2015