Spasticity Due to Cerebral PalsyPhase 1NCT01405950
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Phase 1 study testing Zanaflex Capsules in people with Spasticity Due to Cerebral Palsy, run by Acorda Therapeutics at 1 site in United States.
Trial summary
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Spasticity Due to Cerebral Palsy
- What is being tested?
- Zanaflex Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have clinically diagnosed spasticity resulting from cerebral palsy
- Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years
- Have mild to moderate spasticity at screening
- Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study
Who cannot join
- Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components
- Have dietary restrictions or food allergies that conflict with a standardized meal
- Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention
- Have an ongoing seizure disorder that requires medical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)
Louisville, Kentucky, 40202
About this study
Official title: Single-Dose, Phase 1b Study to Assess Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects With Mild to Moderate Spasticity Due to Cerebral Palsy
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
Read the detailed description
Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.
- Conditions
- Spasticity Due to Cerebral Palsy
- Being tested
- Zanaflex Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanaflex CapsulesDrug
Also called tizanidine HCI (hydrochloride)
0.025 mg/kg
Zanaflex CapsulesDrug
Also called tizanidine HCI (hydrochloride)
0.05 mg/kg
Zanaflex CapsulesDrug
Also called tizanidine HCI (hydrochloride)
0.075 mg/kg
Zanaflex CapsulesDrug
Also called tizanidine HCI (hydrochloride)
0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: Zanaflex Capsules |
| Dose Level 2 | Experimental | Not described Receives: Drug: Zanaflex Capsules |
| Dose Level 3 | Experimental | Not described Receives: Drug: Zanaflex Capsules |
| Dose Level 4 | Experimental | Not described Receives: Drug: Zanaflex Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Secondary outcomes (1)
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.
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).
Measured: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spasticity Due to Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Herbert Henney, PharmD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405950
- Sponsor's protocol ID
- AT10-ZC-08
- Status last verified
- Jun 2013
- First submitted
- 25 Jul 2011
- Last updated
- 17 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Phase 1b Study to Assess Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects With Mild to Moderate Spasticity Due to Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01405950
- Acronym / sponsor ID
- AT10-ZC-08
- Conditions
- Spasticity Due to Cerebral Palsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Posted 13 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
Detailed description
Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: Zanaflex Capsules |
| Dose Level 2 | Experimental | Drug: Zanaflex Capsules |
| Dose Level 3 | Experimental | Drug: Zanaflex Capsules |
| Dose Level 4 | Experimental | Drug: Zanaflex Capsules |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Have clinically diagnosed spasticity resulting from cerebral palsy
- Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years
- Have mild to moderate spasticity at screening
- Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study
Key exclusion criteria (4 listed)
- Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components
- Have dietary restrictions or food allergies that conflict with a standardized meal
- Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention
- Have an ongoing seizure disorder that requires medical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanaflex CapsulesAlso: tizanidine HCI (hydrochloride)0.025 mg/kg | Drug | Dose Level 1 |
| Zanaflex CapsulesAlso: tizanidine HCI (hydrochloride)0.05 mg/kg | Drug | Dose Level 2 |
| Zanaflex CapsulesAlso: tizanidine HCI (hydrochloride)0.075 mg/kg | Drug | Dose Level 3 |
| Zanaflex CapsulesAlso: tizanidine HCI (hydrochloride)0.1 mg/kg | Drug | Dose Level 4 |
Primary outcome
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.
Time frame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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).
1 secondary outcome
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.
Time frame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Henney, PharmD study director
Acorda Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanaflex Capsules in people with Spasticity Due to Cerebral Palsy, run by Acorda Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.