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NCT01556763 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
A Phase 1 study, sponsored by FORUM Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01556763: Completed Phase 1 study, sponsored by FORUM Pharmaceuticals.
NCT01556763 is a Phase 1 study that has completed, run by FORUM Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01556763, a Phase 1 study, has completed, sponsored by FORUM Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG EVP-6124 (0.3 mg/day)
- DRUG EVP-6124 (1.0 mg/day)
- DRUG Antipsychotic therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-04 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
What the finished NCT01556763 record still lists
NCT01556763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01556763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01556763 about?
NCT01556763 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia". This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.
What is the current status of trial NCT01556763?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2008-04. Estimated completion is 2008-08.
What interventions are being tested in trial NCT01556763?
The interventions under investigation include: Placebo (DRUG), EVP-6124 (0.3 mg/day) (DRUG), EVP-6124 (1.0 mg/day) (DRUG), Antipsychotic therapy (DRUG).
Who is sponsoring clinical trial NCT01556763?
This trial is sponsored by FORUM Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01556763's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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