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

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

History of Changes

Results First Received: April 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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

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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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Secondary:

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

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11. Secondary:

P50 Amplitude Difference [ Time Frame: Days -1 to 20 ]

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12. Secondary:

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

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13. Secondary:

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

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Serious Adverse Events

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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

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Limitations and Caveats

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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
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More Information

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