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
  Show 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 ]

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

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 ]

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 ]

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
  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