Trial record 5 of 5 for:    evp-6124, schizophrenia

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01556763
First received: March 14, 2012
Last updated: May 21, 2012
Last verified: May 2012
Results First Received: April 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Central Nervous System Diseases
Interventions: Drug: EVP-6124 (0.3 mg/day)
Drug: EVP-6124 (1.0 mg/day)
Drug: Placebo
Drug: Antipsychotic therapy

  Participant Flow
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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 Matching placebo was administered as one capsule per day for 21 days.
EVP-6124 (1.0 mg/Day) EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
EVP-6124 (0.3 mg/Day) EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

Participant Flow:   Overall Study
    Placebo     EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
STARTED     4     9     8  
COMPLETED     4     8     8  
NOT COMPLETED     0     1     0  
Withdrawal by Subject                 0                 1                 0  



  Baseline Characteristics
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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 Matching placebo was administered as one capsule per day for 21 days.
EVP-6124 (1.0 mg/Day) EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
EVP-6124 (0.3 mg/Day) EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
Total Total of all reporting groups

Baseline Measures
    Placebo     EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)     Total  
Number of Participants  
[units: participants]
  4     9     8     21  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     4     9     8     21  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40.0  ± 11.6     43.1  ± 11.0     51.4  ± 6.9     45.7  ± 10.4  
Gender  
[units: participants]
       
Female     0     3     3     6  
Male     4     6     5     15  
Region of Enrollment  
[units: participants]
       
United States     4     9     8     21  



  Outcome Measures
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1.  Primary:   Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.   [ Time Frame: Screening (Day -5 for continuous cardiac monitoring) to Day 22 ]

2.  Primary:   EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole   [ Time Frame: Days 1 and 21 ]

3.  Primary:   EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole   [ Time Frame: Days 1 and 21 ]

4.  Primary:   EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole   [ Time Frame: Days 1 and 21 ]

5.  Primary:   EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole   [ Time Frame: Days 1 and 21 ]

6.  Primary:   EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone   [ Time Frame: Days 1 and 21 ]

7.  Primary:   EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone   [ Time Frame: Days 1 and 21 ]

8.  Primary:   EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone   [ Time Frame: Days 1 and 21 ]

9.  Primary:   EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone   [ Time Frame: Days 1 and 21 ]

10.  Secondary:   N100 Gating Ratio   [ Time Frame: Days -1 to 20 ]
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Measure Type Secondary
Measure Title N100 Gating Ratio
Measure Description N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.
Time Frame Days -1 to 20  
Safety Issue No  

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.
Subjects providing valid and measurable N100 responses.

Reporting Groups
  Description
Placebo Matching placebo was administered as one capsule per day for 21 days.
EVP-6124 (1.0 mg/Day) EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
EVP-6124 (0.3 mg/Day) EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

Measured Values
    Placebo     EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  2     5     5  
N100 Gating Ratio  
[units: ratio]
Mean ± Standard Error
  1.648  ± 0.29     0.801  ± 0.19     0.951  ± 0.20  


Statistical Analysis 1 for N100 Gating Ratio
Groups [1] Placebo vs. EVP-6124 (1.0 mg/Day)
Method [2] ANCOVA
P Value [3] =0.10
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   P50 Amplitude Difference   [ Time Frame: Days -1 to 20 ]

12.  Secondary:   MMN Summed Amplitude   [ Time Frame: Days -1 to 20 ]

13.  Secondary:   P300 Peak Amplitude   [ Time Frame: Days -1 to 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information