Traumatic Brain InjuryPhase 1NCT00287157
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
A Phase 1 study testing Sublingual Tizanidine HCl in people with Traumatic Brain Injury, run by Teva GTC at 1 site in Israel.
Trial summary
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Sublingual Tizanidine HCl
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to May 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males/Females 8-18 years of age with documented history of TBI
- Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
- Current Spasticity that interferes with task performance
- Patient is able to cooperate and understand general explanations
Who cannot join
- History of allergy to tizanidine or any inactive component (including lactose intolerance)
- Use of other hypnotic medication within 3 days of baseline visit and during the study
- Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
- Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
- Female patients on oral contraceptives
- Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin>2 x uln; Creatinine>2 mg/dl;WBC <2300/mm3, platelets<80,000/mm3)
- Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit
Trial locations and contacts
1 site in 1 country.
Israel1 site
Alyn Hospital Pediatric and Adolescent Rehabilitation Center
Jerusalem, 01090
About this study
Official title: A Double-Blind, Randomized, Two-Way Crossover, Comparative Study to Evaluate the Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl Versus Placebo in Children With Chronic Traumatic Brain Injury
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).
Read the detailed description
Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax), as compared to oral tizanidine (Zanaflex)]. When administered nightly to CP (Cerebral Palsy) patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. This improvement in night-time sleep was translated into a potential improvement in next-day functioning (improvement in next-day measures of spasticity and movement).
It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity, cognition and function, may also be manifest in a similar patient population, children with traumatic brain injury.
- Conditions
- Traumatic Brain Injury
- Being tested
- Sublingual Tizanidine HCl
- Keywords
- Traumatic Brain Injury, Actigraphy, Spasticity, Cognition and Functioning
- Medical subject headings
- Brain Injuries, Traumatic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Tizanidine HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Spasticity, Cognition and Daily Function
Measured: 4 weeks
Secondary outcomes (1)
Improvement in nighttime actigraphy sleep parameters
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startDec 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva GTC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ido Yatsiv, MD, Principal investigator, Hadassah Medical Center, Ein Kerem, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287157
- Sponsor's protocol ID
- Protocol C2/5/TZ-TBI-01
- Status last verified
- Sep 2007
- First submitted
- 2 Feb 2006
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Two-Way Crossover, Comparative Study to Evaluate the Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl Versus Placebo in Children With Chronic Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00287157
- Acronym / sponsor ID
- Protocol C2/5/TZ-TBI-01
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Actigraphy, Spasticity, Cognition and Functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Teva GTCIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- May 2007 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).
Detailed description
Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax), as compared to oral tizanidine (Zanaflex)]. When administered nightly to CP (Cerebral Palsy) patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. This improvement in night-time sleep was translated into a potential improvement in next-day functioning (improvement in next-day measures of spasticity and movement).
It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity, cognition and function, may also be manifest in a similar patient population, children with traumatic brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males/Females 8-18 years of age with documented history of TBI
- Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
- Current Spasticity that interferes with task performance
- Patient is able to cooperate and understand general explanations
Key exclusion criteria (7 listed)
- History of allergy to tizanidine or any inactive component (including lactose intolerance)
- Use of other hypnotic medication within 3 days of baseline visit and during the study
- Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
- Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
- Female patients on oral contraceptives
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 |
|---|---|---|
| Sublingual Tizanidine HCl | Drug | – |
Primary outcome
Improvement in Spasticity, Cognition and Daily Function
Time frame: 4 weeks
1 secondary outcome
Improvement in nighttime actigraphy sleep parameters
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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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.
Ido Yatsiv, MD principal investigator
Hadassah Medical Center, Ein Kerem, Jerusalem
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 Sublingual Tizanidine HCl in people with Traumatic Brain Injury, run by Teva GTC at 1 site in Israel.
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 7 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: finished, as of the sponsor's last update on 21 Jan 2009. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Spasticity, Cognition and Daily Function (time frame: 4 weeks). 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 21 Jan 2009.