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Nepicastat

Phase 2

Posttraumatic Stress Disorder | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 13, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Nepicastat · 1 trial · 1 indication

Phase 2 1
NCT00659230Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF VeteransPosttraumatic Stress Disorder
COMPLETED100 Analytics
PHASE2COMPLETED
Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans
Posttraumatic Stress Disorder
NCT00659230100
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Study Endpoints

Primary Endpoints

Clinician Administered PTSD Scale Subscore D (Hyperarousal)
Baseline, week 2, 4 and 6

The Clinician Administered PTSD Scale subscore D (CAPS-D) measures the hyperarousal cluster for PTSD symptoms (5 items). Higher scores indicate greater severity. Range for CAPS-D is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).

Secondary Endpoints

Clinician Administered PTSD Scale Total Score
Baseline, week 2,4, and 6
Clinician Administered PTSD Scale Subscale B Score
6 weeks
Clinician Administered PTSD Scale Subscale C Score
Baseline, week 2, 4, and 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORArm 1
NepicastatACTIVE_COMPARATORArm 2

Interventions

NameTypeDescription
NepicastatDRUG100-800mg
PlaceboDRUG100-800mg placebo
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Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Signed informed consent * Patient understands the risks and benefits and agrees to visit frequency and procedures * Male or female * Any race or ethnic origin * Served in OIF/OEF or Afghanistan conflicts or other Southwest Asia conditions * Currently Active Duty, National Guar...

Countries:United States
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Frequently asked questions about Nepicastat

What is Nepicastat used for in Posttraumatic Stress Disorder?

Nepicastat is an investigational small molecule being studied for the treatment of Posttraumatic Stress Disorder (PTSD). It has been evaluated in a Phase 2 clinical trial involving veterans with PTSD. The drug is not approved and remains in clinical development.

What does Nepicastat target?

Nepicastat targets the enzyme dopamine beta-hydroxylase, which converts dopamine to norepinephrine. By inhibiting this enzyme, the drug may modulate norepinephrine levels, which are thought to play a role in the symptoms of Posttraumatic Stress Disorder.

Who makes Nepicastat?

Nepicastat is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored clinical trials of the drug for Posttraumatic Stress Disorder.

What phase is Nepicastat in?

Nepicastat is in Phase 2 clinical development. A Phase 2 trial for Posttraumatic Stress Disorder has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Nepicastat in?

Nepicastat has been studied in one completed Phase 2 trial, NCT00659230, titled 'Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans.' The trial enrolled 100 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Nepicastat the same as any other drug?

Nepicastat is also known by the developmental code name SYN-117. It is a single investigational compound and is not the same as any approved drug.