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Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN) (BEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404155
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : January 31, 2023
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland, Baltimore

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Clozapine
Enrollment 274
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clozapine
Hide Arm/Group Description Clozapine
Period Title: Overall Study
Started 274
Completed 227
Not Completed 47
Arm/Group Title Clozapine
Hide Arm/Group Description Clozapine
Overall Number of Baseline Participants 274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
<=18 years
0
   0.0%
Between 18 and 65 years
274
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants
40.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
Female
106
  38.7%
Male
168
  61.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
Hispanic or Latino
7
   2.6%
Not Hispanic or Latino
137
  50.0%
Unknown or Not Reported
130
  47.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
American Indian or Alaska Native
1
   0.4%
Asian
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
255
  93.1%
White
6
   2.2%
More than one race
11
   4.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 274 participants
United States 150
Nigeria 124
1.Primary Outcome
Title Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele.
Hide Description [Not Specified]
Time Frame 24 week period baseline and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Genetic information was only able to be collected and analyzed on 249 of t he 274 overall participants.
Arm/Group Title Clozapine
Hide Arm/Group Description:
Clozapine
Overall Number of Participants Analyzed 249
Mean (Standard Deviation)
Unit of Measure: cells/mm3
Baseline ANC for CC genotype Number Analyzed 199 participants
2755.1  (1271.5)
Endpoint ANC for CC genotype Number Analyzed 199 participants
3079.9  (1563.0)
Baseline ANC for CT genotype Number Analyzed 50 participants
4360.6  (1779.0)
Endpoint ANC for CT genotype Number Analyzed 50 participants
4450.3  (2398.0)
Baseline WBC for CC genotype Number Analyzed 199 participants
5478.9  (1688.1)
Endpoint WBC for CC genotype Number Analyzed 199 participants
5766.1  (1946.4)
Baseline WBC for CT genotype Number Analyzed 50 participants
7802.0  (2142.0)
Endpoint WBC for CT genotype Number Analyzed 50 participants
7702.7  (2607.5)
2.Primary Outcome
Title Number of Episodes of Agranulocytosis (Count).
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clozapine
Hide Arm/Group Description:
Clozapine
Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: Episodes
1
Time Frame For each participants 6 months of enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clozapine
Hide Arm/Group Description Clozapine
All-Cause Mortality
Clozapine
Affected / at Risk (%)
Total   0/274 (0.00%) 
Hide Serious Adverse Events
Clozapine
Affected / at Risk (%)
Total   19/274 (6.93%) 
Blood and lymphatic system disorders   
Severe Neutropenia †  1/274 (0.36%) 
Cardiac disorders   
Pulmonary Emobolism †  1/274 (0.36%) 
Myocarditis †  1/274 (0.36%) 
Gastrointestinal disorders   
Prolapsed Rectum †  1/274 (0.36%) 
Diverticulitis †  1/274 (0.36%) 
Severe Constipation †  1/274 (0.36%) 
Diffuse Ileus †  1/274 (0.36%) 
General disorders   
Hospitalization for Clinical Worsening †  3/274 (1.09%) 
Dehydration †  3/274 (1.09%) 
Atypical Neuroleptic Malignant Syndrome/ Drug Fever †  1/274 (0.36%) 
Pneumonia †  1/274 (0.36%) 
Pleural Effusion †  1/274 (0.36%) 
Unresponsiveness †  1/274 (0.36%) 
Infections and infestations   
Urinary Tract Infection †  1/274 (0.36%) 
Infection/Cellulitis †  2/274 (0.73%) 
Musculoskeletal and connective tissue disorders   
Stroke †  2/274 (0.73%) 
Nervous system disorders   
Seizure †  2/274 (0.73%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clozapine
Affected / at Risk (%)
Total   264/274 (96.35%) 
Cardiac disorders   
Chest Pain †  6/274 (2.19%) 
Myocarditis †  1/274 (0.36%) 
Endocrine disorders   
Salivation †  187/274 (68.25%) 
Gastrointestinal disorders   
Abdominal Pain †  91/274 (33.21%) 
Constipation †  88/274 (32.12%) 
Diarrhea †  64/274 (23.36%) 
Enuresis †  70/274 (25.55%) 
Nausea †  77/274 (28.10%) 
Vomiting †  61/274 (22.26%) 
Weight loss †  29/274 (10.58%) 
General disorders   
Anorexia †  51/274 (18.61%) 
Bruising †  12/274 (4.38%) 
Dizziness †  112/274 (40.88%) 
Dry Mouth †  65/274 (23.72%) 
Fever †  35/274 (12.77%) 
Headache †  86/274 (31.39%) 
Insomnia †  53/274 (19.34%) 
Malaise †  144/274 (52.55%) 
Mucosal †  22/274 (8.03%) 
Rash †  36/274 (13.14%) 
Sedation †  145/274 (52.92%) 
Sore Throat †  49/274 (17.88%) 
Urticaria †  59/274 (21.53%) 
Tinnitus †  37/274 (13.50%) 
Abnormal Ejaculation/Erectile Dysfunction †  2/274 (0.73%) 
Disorientation/Confusion †  2/274 (0.73%) 
Edema †  2/274 (0.73%) 
Myoclonus †  3/274 (1.09%) 
Metabolism and nutrition disorders   
Diabetes/Hyperglycemia †  3/274 (1.09%) 
Musculoskeletal and connective tissue disorders   
Stiffness †  66/274 (24.09%) 
Nervous system disorders   
Restlessness †  79/274 (28.83%) 
Tremors †  73/274 (26.64%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Deanna L. Kelly, Pharm.D., BCPP
Organization: Maryland Psychiatric Research Center
Phone: 410-402-6860
EMail: dlkelly@som.umaryland.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deanna Kelly, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02404155    
Other Study ID Numbers: HP-00063484
First Submitted: February 26, 2015
First Posted: March 31, 2015
Results First Submitted: November 2, 2022
Results First Posted: January 31, 2023
Last Update Posted: January 31, 2023