Attention Deficit Hyperactivity Disorder
Conditions
Keywords
CLONICEL, Attention Deficit Hyperactivity Disorder, clonidine HCl sustained release
Brief summary
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).
Interventions
0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4
Sponsors
Shionogi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation * Age between 6 and 17 years, inclusive * Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria * General good health as judged by the Principal Investigator * Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / \[height (m)\]2 * Subject as well as parent/guardian able to sign informed assent or consent form
Exclusion criteria
* If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device * Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study. * Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings * History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator * Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine * Presence of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4 | At baseline and at Week 4 | — |
| Change From Baseline in Systolic Blood Pressure at Week 4 | At baseline and at Week 4 | Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement |
| Change From Baseline in Body Temperature at Week 4 | At baseline and at Week 4 | Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement |
| Change From Baseline in Heart Rate at Week 4 | At baseline and at Week 4 | Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement |
| Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | 1 year | Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population |
| Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 | At baseline and at Week 4 | — |
| Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12 | — |
| Change From Baseline in Diastolic Blood Pressure at Week 4 | At baseline and at Week 4 | Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | CGI-S scale: 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients |
| Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | CGI-I scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | At baseline, months 1, 2, 3, 4, 6, 9, and 12 | The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18 |
Countries
United States
Participant flow
Recruitment details
This was a multicenter study conducted at 27 study centers in the United States. First subject visit was on January 09, 2008 and last subject completed the study on March 08, 2010
Pre-assignment details
Candidates enrolled in this study (CLON-303) were subjects who completed studies using KAPVAY (CLONICEL) as add-on therapy with stimulants (CLON-302) and as monotherapy (CLON-301). There was no screening period for this study. The safety follow-up visit from these two prior studies (CLON-301 and CLON-302) was the baseline visit for current study
Participants by arm
| Arm | Count |
|---|---|
| KAPVAY (CLONICEL) One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily) | 301 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 16 |
| Overall Study | Lost to Follow-up | 37 |
| Overall Study | Other-Not included in safety population | 2 |
| Overall Study | Other-Premature Discontinuation | 9 |
| Overall Study | Protocol Violation | 15 |
| Overall Study | Withdrawal by Subject | 45 |
Baseline characteristics
| Characteristic | KAPVAY (CLONICEL) |
|---|---|
| Age, Continuous | 10.0 Years |
| Age, Customized > 12-17 Years | 62 Participants |
| Age, Customized 6-12 Years | 239 Participants |
| Race/Ethnicity, Customized Black/African American | 69 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 25 Participants |
| Race/Ethnicity, Customized Other | 21 Participants |
| Race/Ethnicity, Customized White | 186 Participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 221 Participants |
| Weight | 38.1 Kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 246 / 301 |
| serious Total, serious adverse events | 2 / 301 |
Outcome results
Primary
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Time frame: At baseline and at Week 4
Population: Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4 | -10.6 beats per minute | Standard Deviation 14.32 |
Primary
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
Time frame: At baseline and at Week 4
Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 | QT | 17.9 milliseconds | Standard Deviation 25.69 |
| KAPVAY (CLONICEL) | Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 | QTcF | 1.4 milliseconds | Standard Deviation 16.42 |
| KAPVAY (CLONICEL) | Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 | QTcB | -8.0 milliseconds | Standard Deviation 22.15 |
Primary
Change From Baseline in Body Temperature at Week 4
Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Time frame: At baseline and at Week 4
Population: Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Body Temperature at Week 4 | -0.08 Fahrenheit | Standard Deviation 0.791 |
Primary
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
Time frame: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | week 1 (n = 283) | 0.3 Kilograms | Standard Deviation 2.25 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | week 2 (n = 283) | 0.4 Kilograms | Standard Deviation 2.28 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | week 3 (n = 278) | 0.6 Kilograms | Standard Deviation 2.39 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | week 4 (n = 269) | 0.7 Kilograms | Standard Deviation 2.42 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 2 (n = 246) | 0.9 Kilograms | Standard Deviation 2.61 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 3 (n = 232) | 1.2 Kilograms | Standard Deviation 2.97 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 5 (n = 47) | 1.7 Kilograms | Standard Deviation 5.63 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 6 (n = 204) | 2.1 Kilograms | Standard Deviation 3.84 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 9 (n = 123) | 3.6 Kilograms | Standard Deviation 3.72 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 12 (n = 123) | 4.5 Kilograms | Standard Deviation 4.83 |
| KAPVAY (CLONICEL) | Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 | month 4 (n = 212) | 1.4 Kilograms | Standard Deviation 3.25 |
Primary
Change From Baseline in Diastolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time frame: At baseline and at Week 4
Population: Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Diastolic Blood Pressure at Week 4 | -4.2 mmHg | Standard Deviation 9.13 |
Primary
Change From Baseline in Heart Rate at Week 4
Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Time frame: At baseline and at Week 4
Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Heart Rate at Week 4 | -7.0 beats per minute | Standard Deviation 13.59 |
Primary
Change From Baseline in Systolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time frame: At baseline and at Week 4
Population: Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Systolic Blood Pressure at Week 4 | -5.0 mmHg | Standard Deviation 10.71 |
Primary
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
Time frame: 1 year
Population: The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Total number of TEAEs | 954 Events |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Total number of related TEAEs | 438 Events |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Total number of SAEs | 2 Events |
Primary
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population
Time frame: 1 year
Population: The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Total Safety Population | 301 Participants |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Subjects with ≥1 TEAEs | 246 Participants |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Subjects with ≥1 related TEAEs | 178 Participants |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Subjects with ≥1 SAEs | 2 Participants |
| KAPVAY (CLONICEL) | Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) | Subjects with ≥1 TEAEs leading to discontinuation | 17 Participants |
Secondary
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12
The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Population: Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 1-month (n = 229) | -13.7 Units on a scale | Standard Deviation 11.52 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 2-month (n = 221) | -14.4 Units on a scale | Standard Deviation 11.73 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 3-month (n = 203) | -14.8 Units on a scale | Standard Deviation 12.55 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 4-month (n = 142) | -16.3 Units on a scale | Standard Deviation 12.59 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 6-month (n = 184) | -14.6 Units on a scale | Standard Deviation 12.04 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 9-month (n = 119) | -18.1 Units on a scale | Standard Deviation 12.66 |
| KAPVAY (CLONICEL) | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 | 12-month (n = 98) | -14.6 Units on a scale | Standard Deviation 14.05 |
Secondary
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-I scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Population: Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 1-month (n = 229) | 2.5 Units on a scale | Standard Deviation 1.05 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 2-month (n = 220) | 2.5 Units on a scale | Standard Deviation 1.11 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 3-month (n = 202) | 2.5 Units on a scale | Standard Deviation 1.1 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 4-month (n = 143) | 2.3 Units on a scale | Standard Deviation 1.04 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 6-month (n = 185) | 2.4 Units on a scale | Standard Deviation 1.11 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 9-month (n = 119) | 2.1 Units on a scale | Standard Deviation 1.11 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 | 12-month (n = 97) | 2.4 Units on a scale | Standard Deviation 1.39 |
Secondary
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-S scale: 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Population: Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 1-month (n = 229) | -1.2 Units on a scale | Standard Deviation 1.17 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 2-month (n = 220) | -1.3 Units on a scale | Standard Deviation 1.12 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 3-month (n = 202) | -1.3 Units on a scale | Standard Deviation 1.29 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 4-month (n = 143) | -1.5 Units on a scale | Standard Deviation 1.19 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 6-month (n = 185) | -1.4 Units on a scale | Standard Deviation 1.15 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 9-month (n = 119) | -1.7 Units on a scale | Standard Deviation 1.35 |
| KAPVAY (CLONICEL) | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 | 12-month (n = 97) | -1.4 Units on a scale | Standard Deviation 1.46 |