Trial Outcomes & Findings for Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder (NCT NCT01439126)
NCT ID: NCT01439126
Last Updated: 2014-10-27
Results Overview
Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse). The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
COMPLETED
PHASE4
135 participants
From randomization to end of the randomized-withdrawal period (26 weeks)
2014-10-27
Participant Flow
The study was conducted at 34 sites in the US. First patient was enrolled on September 8, 2011 and last patient completed on October 29, 2012
The study population included male or female subjects 6 to 17 years of age, who met the Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV-TR) criteria for Attention Deficit Hyperactivity Disorder (ADHD).
Participant milestones
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.
All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.
Of 68 Subjects randomized to KAPVAY:
24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day
|
Subjects on Placebo
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
Of 67 Subjects randomized to Placebo:
26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
COMPLETED
|
37
|
25
|
|
Overall Study
NOT COMPLETED
|
31
|
42
|
Reasons for withdrawal
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.
All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.
Of 68 Subjects randomized to KAPVAY:
24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day
|
Subjects on Placebo
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
Of 67 Subjects randomized to Placebo:
26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
21
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Other-Use of prohibited treatment
|
0
|
2
|
|
Overall Study
Other-Miscellaneous
|
12
|
12
|
Baseline Characteristics
Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.7 Years
STANDARD_DEVIATION 2.77 • n=5 Participants
|
10.9 Years
STANDARD_DEVIATION 2.98 • n=7 Participants
|
10.8 Years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
40.49 kg
STANDARD_DEVIATION 15.721 • n=5 Participants
|
41.61 kg
STANDARD_DEVIATION 16.978 • n=7 Participants
|
41.05 kg
STANDARD_DEVIATION 16.350 • n=5 Participants
|
|
Height
|
145.64 cm
STANDARD_DEVIATION 17.737 • n=5 Participants
|
145.45 cm
STANDARD_DEVIATION 17.928 • n=7 Participants
|
145.55 cm
STANDARD_DEVIATION 17.833 • n=5 Participants
|
|
BMI
|
18.29 kg/m^2
STANDARD_DEVIATION 2.921 • n=5 Participants
|
18.79 kg/m^2
STANDARD_DEVIATION 3.485 • n=7 Participants
|
18.54 kg/m^2
STANDARD_DEVIATION 3.203 • n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to end of the randomized-withdrawal period (26 weeks)Population: Double-Blind Full Analysis Set. This set included all randomized subjects who took at least 1 dose of study medication during the double blind (randomized-withdrawal) phase
Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse). The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Maintenance of Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Percentage of Treatment Failures in the KAPVAY vs. Placebo Groups
|
31 % of Participants
|
42 % of Participants
|
SECONDARY outcome
Timeframe: Time From randomization to treatment failure (up to 26 weeks)Population: Double-Blind Full Analysis Set
Time to treatment failure was calculated as follows: Treatment failure (not premature termination) = visit date where the failure criteria was met - visit 9 date + 1; Treatment failure (premature termination) = termination date - visit 9 date + 1
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
To Evaluate the Long-term Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Time to Treatment Failure From the Start of Randomized-withdrawal Period
|
212 days
Interval 84.0 to
NA implies the median or the one or both limits in the confidence interval could not be estimated.
|
75 days
Interval 36.0 to 154.0
|
SECONDARY outcome
Timeframe: From randomization to end of the randomized-withdrawal period (26 weeks)Population: Double-Blind Full Analysis Set
The ADHD-RS-IV (clinician version), has been widely used as a measure of efficacy in clinical trials of treatments in children and adolescents with ADHD. It is derived from the 18 inattentive and hyperactive/impulsive diagnostic criteria for ADHD from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). The clinician version of the ADHD-RS-IV has a large base of normative data and has demonstrated reliability and discriminant validity in children and adolescents. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse and a lower score more favourable). Two subscales are summed.
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the ADHD-Rating Scale-4th Edition (ADHD-RS-IV)
|
3.0 scores on a scale
Standard Deviation 10.75
|
7.0 scores on a scale
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: From randomization to end of the randomized-withdrawal period (26 weeks)Population: Double-Blind Full Analysis Set
The CGI-S is a clinician rated instrument designed to assess the subject's current illness state. The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Clinical Global Impressions-Severity of Illness Scale (CGI-S)
|
0.4 scores on a scale
Standard Deviation 1.20
|
0.9 scores on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: From randomization to end of the randomized-withdrawal period (26 weeks)Population: Double-Blind Full Analysis Set
The WFIRS-P is designed to assess the impact of child's behavior or emotional problems on 7 domains related to function: Family (10 items), School Learning (4 items), School Behavior (6 items), Life Skills (10 items), Child's Self-concept (3 items), Social Activities (7 items), and Risky Activities (10 items). Each item was scored on a scale ranging from 0 ("never" or "not at all") to 3 ("very often" or "very much"). Each scale score was calculated as the average for that scale. The total score is the average of all non-missing items. Higher scores are associated with greater impact of disease on functioning.
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P)
|
0.0 units on a scale
Standard Deviation 0.34
|
0.0 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: From randomization to end of the randomized-withdrawal period (26 weeks)Population: Double-Blind Full Analysis Set
Change in the ESS-C scale from randomization to end of randomized-withdrawal period. The ESS-C is a simple eight-tem Likert scale designed to assess daytime sleepiness in children aged 2-18 years. The scale takes less than two minutes to be completed by patient or by parent rating. Sleepiness is a common symptom in both medicated and unmedicated children with ADHD given the predominance of impaired sleep quality. The total score achieved when the chance of dozing in each situation is added up serves as the outcome measure. The ESS-C comprises 8 items describing various daytime activities. Item scores ranging from 0 ("would never doze or sleep") to 3 ("high chance of dozing or sleeping"). A total score is derived as the sum of the items, with higher total scores indicative of a greater level of sleepiness (worse outcome). Total scores range from 0 to 24.
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Epworth Sleepiness Scale for Children (ESS-C)
|
-0.6 units on a scale
Standard Deviation 3.18
|
-0.6 units on a scale
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: From study start to study end (40 weeks)Population: Double-Blind Full Analysis Set
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
No. Subjects with At Least 1 Treatment-Emergent AE
|
34 Participants
|
31 Participants
|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
Any Severe Treatment-Emergent AE (TEAE)
|
2 Participants
|
0 Participants
|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
Any SAE
|
0 Participants
|
2 Participants
|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
Treatment Emergent AE leading to discontinuation
|
2 Participants
|
0 Participants
|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
Any Treatment-Related AE
|
18 Participants
|
12 Participants
|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs
Vital Signs Abnormalities
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 20 (Week 40)Population: Double-Blind Full Analysis Set
The outcome reported is the number of subjects that responded "Yes" to the question "Do you have a wish to be dead" at Visit 20. C-SSRS is a clinician-rated instrument designed to provide consistent and systematic assessment of both suicidal ideation and behavior within a study, as well as across studies. The scale is a feasible, low burden series of questions that appropriately assess and track all suicidal events, including ideation. Suicidal ideation is assessed according to yes/no responses to 5 questions of increasing severity (from a wish to die to an active thought of killing oneself with plan and intent) as follows: 1. Wish to be Dead 2. Non-Specific Active Suicidal Thoughts 3. Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 4. Active Suicidal Ideation with Some Intent to Act, without Specific Plan 5. Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 Participants
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 Participants
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Changes in the Columbia Suicide Severity Rating Scale (C-SSRS)
|
0 participants
|
1 participants
|
Adverse Events
Subjects on KAPVAY (Clonidine Hydrochloride)
Subjects on Placebo
Serious adverse events
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 participants at risk
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 participants at risk
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/68 • Throughout the study
|
1.5%
1/67 • Throughout the study
|
|
Blood and lymphatic system disorders
Sickle cell anemia with crisis
|
0.00%
0/68 • Throughout the study
|
1.5%
1/67 • Throughout the study
|
Other adverse events
| Measure |
Subjects on KAPVAY (Clonidine Hydrochloride)
n=68 participants at risk
Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
|
Subjects on Placebo
n=67 participants at risk
Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
4.4%
3/68 • Throughout the study
|
0.00%
0/67 • Throughout the study
|
|
Nervous system disorders
Headache
|
2.9%
2/68 • Throughout the study
|
4.5%
3/67 • Throughout the study
|
|
Nervous system disorders
Sedation
|
1.5%
1/68 • Throughout the study
|
1.5%
1/67 • Throughout the study
|
|
Nervous system disorders
Dizziness postural
|
2.9%
2/68 • Throughout the study
|
3.0%
2/67 • Throughout the study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/68 • Throughout the study
|
1.5%
1/67 • Throughout the study
|
|
General disorders
Fatigue
|
1.5%
1/68 • Throughout the study
|
0.00%
0/67 • Throughout the study
|
|
Investigations
Electrocardiogram QT
|
2.9%
2/68 • Throughout the study
|
0.00%
0/67 • Throughout the study
|
|
Investigations
Weight increased
|
2.9%
2/68 • Throughout the study
|
0.00%
0/67 • Throughout the study
|
|
Psychiatric disorders
Affect lability
|
1.5%
1/68 • Throughout the study
|
0.00%
0/67 • Throughout the study
|
Additional Information
John AR McCleery, CPA, CA, Managing Director and CFO
Concordia Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER