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Trial record 5 of 5 for:    evp-6124, schizophrenia
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Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01556763
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : June 21, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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

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

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events

Time Frame Screening to Day 22
Additional Description 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.

Serious Adverse Events
    Placebo   EVP-6124 (1.0 mg/Day)   EVP-6124 (0.3 mg/Day)
Total, Serious Adverse Events       
# participants affected / at risk   0/4 (0.00%)   0/9 (0.00%)   1/8 (12.50%) 
Psychiatric disorders       
Psychiatric symptom       
# participants affected / at risk   0/4 (0.00%)   0/9 (0.00%)   1/8 (12.50%) 
# events   0   0   1 




  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