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 ]

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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Maria Gawryl, Ph.D., Vice President, Regulatory Affairs & Drug Development
Organization: EnVivo Pharmaceuticals, Inc.
phone: 617-225-4264
e-mail: mgawryl@envivopharma.com


No publications provided by FORUM Pharmaceuticals Inc

Publications automatically indexed to this study:

Responsible Party: FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01556763     History of Changes
Other Study ID Numbers: EVP-6124-005
Study First Received: March 14, 2012
Results First Received: April 18, 2012
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration