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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
  Hide 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 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
  Hide 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 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
  Hide All Outcome Measures

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 ]

Measure Type Primary
Measure Title Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.
Measure Description Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis).
Time Frame Screening (Day -5 for continuous cardiac monitoring) to Day 22  
Safety Issue Yes  

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.
All randomized patients who ingested at least one dose of study drug or placebo.

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]
  4     9     8  
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.  
[units: participants]
     
Serious Adverse Events     0     0     1  
Non-Serious Adverse Events     0     5     5  
No Adverse Events Reported     4     4     3  

No statistical analysis provided for Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.



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

Measure Type Primary
Measure Title EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole
Measure Description Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving aripiprazole.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  7     3  
EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole  
[units: pg/mL]
Mean ± Standard Deviation
   
Day 1     581.0  ± 149.8     210.0  ± 39.3  
Day 21     2058.6  ± 393.2     968.3  ± 90.1  

No statistical analysis provided for EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole



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

Measure Type Primary
Measure Title EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving aripiprazole.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  7     3  
EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole  
[units: hr]
Median ( Full Range )
   
Day 1     8.0  
  ( 2 to 8 )  
  8.0  
  ( 6 to 8 )  
Day 21     6.0  
  ( 2 to 8 )  
  8.0  
  ( 1 to 8 )  

No statistical analysis provided for EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole



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

Measure Type Primary
Measure Title EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving aripiprazole.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  7     3  
EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole  
[units: pg*hr/mL]
Mean ± Standard Deviation
   
Day 1     10,966  ± 2831     3838  ± 1044  
Day 21     42,042  ± 9623     20,560  ± 2699  

No statistical analysis provided for EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole



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

Measure Type Primary
Measure Title EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
Patients receiving aripiprazole for whom blood samples were available for analysis.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  1     1  
EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole  
[units: hr]
Mean ± Standard Deviation
   
Day 1     39.0  ± NA [1]   43.1  ± NA [1]
Day 21     NA  ± NA [2]   116.6  ± NA [1]
[1] Data for only one patient were available.
[2] The patient withdrew consent after receiving study drug for 3 days.

No statistical analysis provided for EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole



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

Measure Type Primary
Measure Title EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving paliperidone/risperidone.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  1     5  
EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone  
[units: pg/mL]
Mean ± Standard Deviation
   
Day 1     315.0  ± NA [1]   165.0  ± 40.2  
Day 21     1510.0  ± NA [1]   545.4  ± 130.2  
[1] Data for only one patient were available.

No statistical analysis provided for EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone



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

Measure Type Primary
Measure Title EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving paliperidone/risperidone.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  1     5  
EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone  
[units: hr]
Median ( Full Range )
   
Day 1     6.0  
  ( NA to NA ) [1]
  8.0  
  ( 6 to 8 )  
Day 21     6.0  
  ( NA to NA ) [1]
  8.0  
  ( 8 to 8 )  
[1] Data for only one patient were available.

No statistical analysis provided for EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone



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

Measure Type Primary
Measure Title EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
All patients receiving paliperidone/risperidone.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  1     5  
EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone  
[units: pg*hr/ml]
Mean ± Standard Deviation
   
Day 1     6359  ± NA [1]   3110  ± 852  
Day 21     33,042  ± NA [1]   11,888  ± 3095  
[1] Data for only one patient were available.

No statistical analysis provided for EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone



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

Measure Type Primary
Measure Title EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone
Measure Description Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time Frame Days 1 and 21  
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.
Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.

Reporting Groups
  Description
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
    EVP-6124 (1.0 mg/Day)     EVP-6124 (0.3 mg/Day)  
Number of Participants Analyzed  
[units: participants]
  1     2  
EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone  
[units: hr]
Mean ± Standard Deviation
   
Day 1     92.0  ± NA [1]   45.8  ± 17.7  
Day 21     NA  ± NA [2]   78.1  ± 8.3  
[1] Data for only one patient were available.
[2] Sample not analyzed.

No statistical analysis provided for EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone



10.  Secondary:   N100 Gating Ratio   [ Time Frame: Days -1 to 20 ]

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 ]

Measure Type Secondary
Measure Title P50 Amplitude Difference
Measure Description P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher 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 P50 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  
P50 Amplitude Difference  
[units: microvolts]
Mean ± Standard Error
  -0.17  ± 0.38     0.67  ± 0.21     -0.06  ± 0.25  


Statistical Analysis 1 for P50 Amplitude Difference
Groups [1] Placebo vs. EVP-6124 (1.0 mg/Day)
Method [2] ANCOVA
P Value [3] =0.07
[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.



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

Measure Type Secondary
Measure Title MMN Summed Amplitude
Measure Description Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative 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 MMN 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]
  4     8     7  
MMN Summed Amplitude  
[units: microvolts]
Mean ± Standard Error
  0.14  ± 0.33     -1.15  ± 0.24     -0.61  ± 0.25  


Statistical Analysis 1 for MMN Summed Amplitude
Groups [1] All groups
Method [2] ANCOVA
P Value [3] =0.02
[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.



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

Measure Type Secondary
Measure Title P300 Peak Amplitude
Measure Description P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive 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 P300 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]
  4     8     7  
P300 Peak Amplitude  
[units: microvolts]
Mean ± Standard Error
  -0.3  ± 0.31     1.08  ± 0.22     0.78  ± 0.24  


Statistical Analysis 1 for P300 Peak Amplitude
Groups [1] All groups
Method [2] ANCOVA
P Value [3] =0.008
[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.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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