Central Nervous System Diseases, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective, CNS
Brief summary
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.
Detailed description
Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and cognitive testing will be performed.
Interventions
EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
DRUGPlacebo
Matching placebo was administered as one capsule per day for 21 days.
DRUGAntipsychotic therapy
Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.
Sponsors
FORUM Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 to 55 years (both inclusive). * Females must be surgically sterile, post-menopausal, or using reliable contraception and have negative pregnancy tests at screening and at Day -1. * A clinical diagnosis of schizophrenia or schizoaffective disorder and prescribed a stable dose of aripiprazole (10 to 30 mg/day), olanzapine (10 to 20 mg/day), paliperidone (3 to 12 mg/day), or risperidone (2 to 16 mg/day) for a minimum of 2 weeks before initial screening. * In good general health and expected to complete the clinical trial as designed. * Body Mass Index (BMI) of 18 kg/m\^2 to 38 kg/m\^2 (both inclusive) at screening. * Adequate hearing, vision, and language skills to perform the cognitive testing and other procedures specified in the protocol. * Voluntarily provided informed consent and signed an informed consent form (ICF) indicating that the purpose of the study was explained, and was willing and able to adhere to the study regimen and study procedures described in the ICF, including all confinement requirements. * Negative urine drug screen at screening and inpatient observation baseline period (Day -6), except for a short-acting benzodiazepine if prescribed for insomnia. * Fluent in English (speaking, writing, and reading).
Exclusion criteria
* Female subject who was pregnant or breast-feeding. * Any active clinically significant medical condition within 1 month (30 days) prior to screening. * A history of substance (drug) dependence or substance or alcohol abuse within the 12 months before randomization as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). * A score of \>5 on any item on the PANSS (Positive and Negative Syndrome Scale) Positive subscale at baseline during the inpatient observation period (Day -1). * Any laboratory test abnormalities at screening indicating hepatic or renal dysfunction, or any other laboratory test abnormalities deemed by the investigator to be clinically significant. * Any hematologic malignancy or solid tumor diagnosed within 3 years prior to study entry with the exception of localized skin cancer or carcinoma in situ of the cervix. * Known to have had or was a carrier of HBsAg, HCV antibody, or had a positive result to the HIV-1 and/or HIV-2 antibodies. * Uncooperative with or could not complete the study procedures. * Received an investigational drug within 30 days before screening. * Donated blood within 30 days before randomization on Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Screening (Day -5 for continuous cardiac monitoring) to Day 22 | 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). |
| EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Days 1 and 21 | Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| P50 Amplitude Difference | Days -1 to 20 | 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. |
| MMN Summed Amplitude | Days -1 to 20 | 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. |
| P300 Peak Amplitude | Days -1 to 20 | 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. |
| N100 Gating Ratio | Days -1 to 20 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo was administered as one capsule per day for 21 days. | 4 |
| EVP-6124 (1.0 mg/Day) EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. | 9 |
| EVP-6124 (0.3 mg/Day) EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. | 8 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | EVP-6124 (1.0 mg/Day) | EVP-6124 (0.3 mg/Day) | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 4 Participants | 21 Participants |
| Age Continuous | 43.1 years STANDARD_DEVIATION 11 | 51.4 years STANDARD_DEVIATION 6.9 | 40.0 years STANDARD_DEVIATION 11.6 | 45.7 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 9 participants | 8 participants | 4 participants | 21 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 5 / 9 | 5 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 9 | 1 / 8 |
Outcome results
Primary
EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving aripiprazole.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Day 1 | 10,966 pg*hr/mL | Standard Deviation 2831 |
| Placebo | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Day 21 | 42,042 pg*hr/mL | Standard Deviation 9623 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Day 1 | 3838 pg*hr/mL | Standard Deviation 1044 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Day 21 | 20,560 pg*hr/mL | Standard Deviation 2699 |
Primary
EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving paliperidone/risperidone.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Day 1 | 6359 pg*hr/ml | — |
| Placebo | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Day 21 | 33,042 pg*hr/ml | — |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Day 1 | 3110 pg*hr/ml | Standard Deviation 852 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Day 21 | 11,888 pg*hr/ml | Standard Deviation 3095 |
Primary
EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: Patients receiving aripiprazole for whom blood samples were available for analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Day 1 | 39.0 hr |
| Placebo | EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Day 21 | NA hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Day 1 | 43.1 hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Day 21 | 116.6 hr |
Primary
EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Day 1 | 92.0 hr | — |
| Placebo | EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Day 21 | NA hr | — |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Day 1 | 45.8 hr | Standard Deviation 17.7 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Day 21 | 78.1 hr | Standard Deviation 8.3 |
Primary
EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole
Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving aripiprazole.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Day 1 | 581.0 pg/mL | Standard Deviation 149.8 |
| Placebo | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Day 21 | 2058.6 pg/mL | Standard Deviation 393.2 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Day 1 | 210.0 pg/mL | Standard Deviation 39.3 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Day 21 | 968.3 pg/mL | Standard Deviation 90.1 |
Primary
EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving paliperidone/risperidone.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Day 1 | 315.0 pg/mL | — |
| Placebo | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Day 21 | 1510.0 pg/mL | — |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Day 1 | 165.0 pg/mL | Standard Deviation 40.2 |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Day 21 | 545.4 pg/mL | Standard Deviation 130.2 |
Primary
EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving aripiprazole.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Day 1 | 8.0 hr |
| Placebo | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Day 21 | 6.0 hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Day 1 | 8.0 hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Day 21 | 8.0 hr |
Primary
EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone
Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.
Time frame: Days 1 and 21
Population: All patients receiving paliperidone/risperidone.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Day 1 | 6.0 hr |
| Placebo | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Day 21 | 6.0 hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Day 1 | 8.0 hr |
| EVP-6124 (1.0 mg/Day) | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Day 21 | 8.0 hr |
Primary
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.
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
Population: All randomized patients who ingested at least one dose of study drug or placebo.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Non-Serious Adverse Events | 0 participants | 0 |
| Placebo | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Serious Adverse Events | 0 participants | 0 |
| Placebo | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | No Adverse Events Reported | 4 participants | 0 |
| EVP-6124 (1.0 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Non-Serious Adverse Events | 5 participants | 0 |
| EVP-6124 (1.0 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Serious Adverse Events | 0 participants | 0 |
| EVP-6124 (1.0 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | No Adverse Events Reported | 4 participants | 0 |
| EVP-6124 (0.3 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Serious Adverse Events | 1 participants | 0 |
| EVP-6124 (0.3 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | No Adverse Events Reported | 3 participants | 0 |
| EVP-6124 (0.3 mg/Day) | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Non-Serious Adverse Events | 5 participants | 0 |
Secondary
MMN Summed Amplitude
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
Population: Subjects providing valid and measurable MMN responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | MMN Summed Amplitude | 0.14 microvolts | Standard Error 0.33 |
| EVP-6124 (1.0 mg/Day) | MMN Summed Amplitude | -1.15 microvolts | Standard Error 0.24 |
| EVP-6124 (0.3 mg/Day) | MMN Summed Amplitude | -0.61 microvolts | Standard Error 0.25 |
Comparison: 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.p-value: =0.02ANCOVA
Secondary
N100 Gating Ratio
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
Population: Subjects providing valid and measurable N100 responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | N100 Gating Ratio | 1.648 ratio | Standard Error 0.29 |
| EVP-6124 (1.0 mg/Day) | N100 Gating Ratio | 0.801 ratio | Standard Error 0.19 |
| EVP-6124 (0.3 mg/Day) | N100 Gating Ratio | 0.951 ratio | Standard Error 0.2 |
Comparison: 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.p-value: =0.1ANCOVA
Secondary
P300 Peak Amplitude
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
Population: Subjects providing valid and measurable P300 responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | P300 Peak Amplitude | -0.3 microvolts | Standard Error 0.31 |
| EVP-6124 (1.0 mg/Day) | P300 Peak Amplitude | 1.08 microvolts | Standard Error 0.22 |
| EVP-6124 (0.3 mg/Day) | P300 Peak Amplitude | 0.78 microvolts | Standard Error 0.24 |
Comparison: 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.p-value: =0.008ANCOVA
Secondary
P50 Amplitude Difference
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
Population: Subjects providing valid and measurable P50 responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | P50 Amplitude Difference | -0.17 microvolts | Standard Error 0.38 |
| EVP-6124 (1.0 mg/Day) | P50 Amplitude Difference | 0.67 microvolts | Standard Error 0.21 |
| EVP-6124 (0.3 mg/Day) | P50 Amplitude Difference | -0.06 microvolts | Standard Error 0.25 |
Comparison: 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.p-value: =0.07ANCOVA