Trial · NCT01556763

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia

NCT01556763, Phase 1, Completed, FORUM Pharmaceuticals Inc; results first posted 2012-06-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia. Trials, record NCT01556763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01556763

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
NCT number: NCT01556763
Status: Completed
Phases: Phase 1
Enrollment: 21 participants, actual
Lead sponsor: FORUM Pharmaceuticals Inc
Conditions: Schizophrenia, Schizoaffective Disorder, Central Nervous System Diseases
Interventions: EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day), Placebo, Antipsychotic therapy
First posted: 2012-03-16
Last updated: 2012-06-21
Results first posted: 2012-06-21

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	All randomized patients who ingested at least one dose of study drug or placebo.	participants	NUMBER
PRIMARY	EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole	Days 1 and 21	All patients receiving aripiprazole.	pg/mL	MEAN
PRIMARY	EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole	Days 1 and 21	All patients receiving aripiprazole.	hr	MEDIAN
PRIMARY	EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole	Days 1 and 21	All patients receiving aripiprazole.	pg*hr/mL	MEAN
PRIMARY	EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole	Days 1 and 21	Patients receiving aripiprazole for whom blood samples were available for analysis.	hr	MEAN
PRIMARY	EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone	Days 1 and 21	All patients receiving paliperidone/risperidone.	pg/mL	MEAN
PRIMARY	EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone	Days 1 and 21	All patients receiving paliperidone/risperidone.	hr	MEDIAN
PRIMARY	EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone	Days 1 and 21	All patients receiving paliperidone/risperidone.	pg*hr/ml	MEAN
PRIMARY	EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone	Days 1 and 21	Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.	hr	MEAN
SECONDARY	N100 Gating Ratio	Days -1 to 20	Subjects providing valid and measurable N100 responses.	ratio	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group53

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	Placebo	Serious Adverse Events	0	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (1.0 mg/Day)	Serious Adverse Events	0	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (0.3 mg/Day)	Serious Adverse Events	1	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	Placebo	Non-Serious Adverse Events	0	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (1.0 mg/Day)	Non-Serious Adverse Events	5	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (0.3 mg/Day)	Non-Serious Adverse Events	5	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	Placebo	No Adverse Events Reported	4	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (1.0 mg/Day)	No Adverse Events Reported	4	0	participants
Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.	EVP-6124 (0.3 mg/Day)	No Adverse Events Reported	3	0	participants
EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole	EVP-6124 (1.0 mg/Day)	Day 1	581.0	Standard Deviation 149.8	pg/mL

1 to 10 of 53Source ClinicalTrials.gov

See all 53 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	4
Overall Study	STARTED	EVP-6124 (1.0 mg/Day)	9
Overall Study	STARTED	EVP-6124 (0.3 mg/Day)	8
Overall Study	COMPLETED	Placebo	4
Overall Study	COMPLETED	EVP-6124 (1.0 mg/Day)	8
Overall Study	COMPLETED	EVP-6124 (0.3 mg/Day)	8
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	EVP-6124 (1.0 mg/Day)	1
Overall Study	NOT COMPLETED	EVP-6124 (0.3 mg/Day)	0

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Tinea cruris	Infections and infestations	Placebo	0	4	0
other	Tinea cruris	Infections and infestations	EVP-6124 (1.0 mg/Day)	0	9	0
other	Tinea cruris	Infections and infestations	EVP-6124 (0.3 mg/Day)	1	8	1
other	Neutrophil count increased	Investigations	Placebo	0	4	0
other	Neutrophil count increased	Investigations	EVP-6124 (1.0 mg/Day)	1	9	1
other	Neutrophil count increased	Investigations	EVP-6124 (0.3 mg/Day)	0	8	0
other	White blood cell count increased	Investigations	Placebo	0	4	0
other	White blood cell count increased	Investigations	EVP-6124 (1.0 mg/Day)	1	9	1
other	White blood cell count increased	Investigations	EVP-6124 (0.3 mg/Day)	0	8	0
other	Psychiatric symptom	Psychiatric disorders	Placebo	0	4	0

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	EVP-6124 (1.0 mg/Day)
Total, all-cause mortality	EVP-6124 (0.3 mg/Day)
Total, other adverse events	Placebo	0	4
Total, other adverse events	EVP-6124 (1.0 mg/Day)	5	9
Total, other adverse events	EVP-6124 (0.3 mg/Day)	5	8
Total, serious adverse events	Placebo	0	4
Total, serious adverse events	EVP-6124 (1.0 mg/Day)	0	9
Total, serious adverse events	EVP-6124 (0.3 mg/Day)	1	8

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24419307	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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