Trial Outcomes & Findings for Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy (NCT NCT01405950)
NCT ID: NCT01405950
Last Updated: 2013-06-17
Results Overview
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Results posted on
2013-06-17
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
Zanaflex Capsules : 0.05 mg/kg
|
Dose Level 3
Zanaflex Capsules : 0.075 mg/kg
|
Dose Level 4
Zanaflex Capsules : 0.1 mg/kg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
7
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
Zanaflex Capsules : 0.05 mg/kg
|
Dose Level 3
Zanaflex Capsules : 0.075 mg/kg
|
Dose Level 4
Zanaflex Capsules : 0.1 mg/kg
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=8 Participants
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
n=2 Participants
Zanaflex Capsules : 0.05 mg/kg
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2-3 years
|
3 participants
n=39 Participants
|
0 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Age, Customized
4-5 years
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Age, Customized
6-12 years
|
3 participants
n=39 Participants
|
2 participants
n=41 Participants
|
5 participants
n=35 Participants
|
|
Age, Customized
13-16 years
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: Pharmacokinetics Population
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
n=2 Participants
Zanaflex Capsules : 0.05 mg/kg
|
Dose Level 3
Zanaflex Capsules: 0.075 mg/kg
|
Dose Level 4
Zanaflex Capsules: 0.1 mg/kg
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.
|
5.60 hour*nanogram/mililiter
Standard Error 1.79
|
6.11 hour*nanogram/mililiter
Standard Error 1.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: Pharmacokinetics Population
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
n=2 Participants
Zanaflex Capsules : 0.05 mg/kg
|
Dose Level 3
Zanaflex Capsules: 0.075 mg/kg
|
Dose Level 4
Zanaflex Capsules: 0.1 mg/kg
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.
|
1.87 nanogram/mililiter
Standard Error 0.60
|
5.29 nanogram/mililiter
Standard Error 0.05
|
—
|
—
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Level 1
n=8 participants at risk
Zanaflex Capsules : 0.025 mg/kg
|
Dose Level 2
n=2 participants at risk
Zanaflex Capsules : 0.05 mg/kg
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/8 • Up to 30 days.
Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start-date/time of administration of study drug and no more than 1 day after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to 30 days.
Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start-date/time of administration of study drug and no more than 1 day after the last dose of study drug.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • Up to 30 days.
Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start-date/time of administration of study drug and no more than 1 day after the last dose of study drug.
|
100.0%
2/2 • Number of events 2 • Up to 30 days.
Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start-date/time of administration of study drug and no more than 1 day after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
- Publication restrictions are in place
Restriction type: OTHER