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An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT01323192
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention-Deficit Hyperactivity Disorder
Interventions Drug: JNS001
Drug: Placebo
Enrollment 284
Recruitment Details The study was conducted at 39 study sites in Japan.
Pre-assignment Details 284 participants were randomly assigned and treated with JNS001 or placebo in this study. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. Participants received matching placebo orally once daily for 8 weeks.
Period Title: Overall Study
Started 143 141
Completed 134 135
Not Completed 9 6
Reason Not Completed
Adverse Event             6             1
Withdrawal by Subject             3             1
Noncompliance with study medication             0             3
Nonmedical reasons             0             1
Arm/Group Title JNS001 Placebo Total
Hide Arm/Group Description Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. Participants received matching placebo orally once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 143 141 284
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants 141 participants 284 participants
18-24 years of age 24 19 43
25-35 years of age 60 65 125
36-49 years of age 55 51 106
50-64 years of age 4 6 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 141 participants 284 participants
Female
72
  50.3%
73
  51.8%
145
  51.1%
Male
71
  49.7%
68
  48.2%
139
  48.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants 141 participants 284 participants
Asian 143 139 282
Other 0 2 2
1.Primary Outcome
Title Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)
Hide Description CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Time Frame Baseline (Day 0) to Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-12.5  (9.27) -7.9  (9.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-6.7 to -2.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.10
Estimation Comments LS mean of JNS001 minus LS mean of Placebo
2.Secondary Outcome
Title Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score
Hide Description CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Time Frame Baseline (Day 0) to Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-19.5  (15.42) -12.5  (15.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -6.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.83
Estimation Comments LS mean of JNS001 minus LS mean of Placebo
3.Secondary Outcome
Title Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores
Hide Description The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Time Frame Baseline (Day 0) to Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Median (Full Range)
Unit of Measure: Scores on a scale
-1.0
(-5 to 1)
-1.0
(-4 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C) Scores
Hide Description The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.
Time Frame Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Median (Full Range)
Unit of Measure: Scores on a scale
3
(1 to 6)
3
(1 to 6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score
Hide Description CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Time Frame Baseline (Day 0) to Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-18.0  (16.45) -10.9  (16.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -6.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.83
Estimation Comments LS mean of JNS001 minus LS mean of Placebo
6.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores
Hide Description Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score −minimum score) / (maximum possible raw score −minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life.
Time Frame Baseline (Day 0) to Endpoint (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description:
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
Participants received matching placebo orally once daily for 8 weeks.
Overall Number of Participants Analyzed 143 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.4  (14.00) 0.8  (12.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JNS001, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4041
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 9 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JNS001 Placebo
Hide Arm/Group Description Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. Participants received matching placebo orally once daily for 8 weeks.
All-Cause Mortality
JNS001 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
JNS001 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/143 (1.40%)   0/141 (0.00%) 
Psychiatric disorders     
Psychotic disorder  1  1/143 (0.70%)  0/141 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax spontaneous tension  1  1/143 (0.70%)  0/141 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
JNS001 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   117/143 (81.82%)   76/141 (53.90%) 
Cardiac disorders     
Palpitations  1  26/143 (18.18%)  2/141 (1.42%) 
Tachycardia  1  8/143 (5.59%)  0/141 (0.00%) 
Gastrointestinal disorders     
Nausea  1  21/143 (14.69%)  4/141 (2.84%) 
Diarrhoea  1  6/143 (4.20%)  6/141 (4.26%) 
Abdominal discomfort  1  7/143 (4.90%)  0/141 (0.00%) 
Vomiting  1  5/143 (3.50%)  0/141 (0.00%) 
Abdominal pain  1  3/143 (2.10%)  1/141 (0.71%) 
Constipation  1  4/143 (2.80%)  0/141 (0.00%) 
Dyspepsia  1  3/143 (2.10%)  1/141 (0.71%) 
General disorders     
Thirst  1  20/143 (13.99%)  6/141 (4.26%) 
Pyrexia  1  7/143 (4.90%)  0/141 (0.00%) 
Malaise  1  6/143 (4.20%)  0/141 (0.00%) 
Chest discomfort  1  4/143 (2.80%)  0/141 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  24/143 (16.78%)  19/141 (13.48%) 
Upper respiratory tract infection  1  3/143 (2.10%)  3/141 (2.13%) 
Investigations     
Weight decreased  1  10/143 (6.99%)  0/141 (0.00%) 
Blood creatine phosphokinase increased  1  3/143 (2.10%)  2/141 (1.42%) 
Blood triglycerides increased  1  0/143 (0.00%)  3/141 (2.13%) 
Metabolism and nutrition disorders     
Decreased appetite  1  57/143 (39.86%)  10/141 (7.09%) 
Nervous system disorders     
Headache  1  12/143 (8.39%)  9/141 (6.38%) 
Dizziness  1  6/143 (4.20%)  2/141 (1.42%) 
Somnolence  1  0/143 (0.00%)  3/141 (2.13%) 
Tremor  1  3/143 (2.10%)  0/141 (0.00%) 
Psychiatric disorders     
Insomnia  1  15/143 (10.49%)  14/141 (9.93%) 
Anxiety  1  6/143 (4.20%)  3/141 (2.13%) 
Vascular disorders     
Hot flush  1  4/143 (2.80%)  0/141 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Medical Director
Organization: Janssen Pharm KK Japan
Phone: +81-3-4411-5509
Layout table for additonal information
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01323192    
Other Study ID Numbers: CR017755
JNS001-JPN-A01 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: March 10, 2011
First Posted: March 25, 2011
Results First Submitted: June 27, 2013
Results First Posted: September 6, 2013
Last Update Posted: September 6, 2013