Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia

Part of paid clinical trials in Glendale, California.

Sponsor
Newron Pharmaceuticals SPA
Study ID
NCT04461119
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evenamide — DRUG
    oral capsules for 4 weeks of treatment
  • Placebo — DRUG
    oral capsules for 4 weeks of treatment

Study Details

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

Key Dates

Start date
Jun 16, 2020
Status verified
May 2021
Primary completion
Feb 20, 2021
Completion
Mar 13, 2021

Study Design

Enrollment
138 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evenamide 7.5 mg bid
    Evenamide capsules 7.5 mg BID for a total of 28 dosing days
  • Experimental: Evenamide 15 mg bid
    Evenamide capsules 15.0 mg BID for a total of 28 dosing days
  • Placebo Comparator: Placebo
    Matching placebo capsules BID for a total of 28 dosing days

Primary Outcome Measure

Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs] [ Time Frame: 4 Week study ]

Locations (3)

FacilityCityStateZIPSite coordinators
Behavioral Research Specialists, LLCGlendaleCalifornia91206-
CBH Health, LLCGaithersburgMaryland20877-
Community Clinical Research CCRAustinTexas78754-

Find similar trials in Glendale, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Behavioral Research Specialists, LLC· Glendale, CACBH Health, LLC· Gaithersburg, MDCommunity Clinical Research CCR· Austin, TX

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