SpasticityPhase 1NCT00280280
Botox vs. Baclofen for Upper Limb Spasticity
A Phase 1 study testing intramuscular Botox versus oral baclofen in people with Spasticity, run by Vanderbilt University at 1 site in United States.
Trial summary
The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- intramuscular Botox versus oral baclofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient, male or female subjects of any race, and at least 18 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 50mlU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study;
- Minimal 4-month history stable neurological disorder resulting focal upper limb muscle spasticity (wrist and/or elbow)
- Disability Assessment Scale (DAS) ≥ 2 for the principal therapeutic intervention target as chosen by Investigator and Subject (i.e., hygiene, dressing, pain and cosmesis).
- Subjects who are able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and are not practicing a reliable method of birth control.
- Severe contracture at the wrist or a history of tendon transfer in the study limb.
- Cast of study limb within four weeks of Visit 1.
- Profound atrophy of the muscles in the target area(s) of injection.
- Progressive neurological disorder (e.g., multiple sclerosis).
- Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
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- Orthostatic hypotension or current use of alpha-2 adrenergic agonists (e.g. clonidine).
- Current anticoagulant therapy and INR > 3.5
- Significantly impaired renal and/or hepatic function, in the opinion of the Investigator.
- Failure to meet prohibited concomitant medication criteria (Supplement I)
- Subjects planning inpatient surgery during the study.
- Any uncontrolled systemic disease.
- Allergy or sensitivity to any component of the study medication.
- Recent alcohol or drug abuse.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37232-2551
About this study
Official title: Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study
The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance.
Read the detailed description
Spasticity results from any injury to the central nervous system, including brain or spinal cord. Illnesses or injuries that typically cause spasticity include cerebral palsy, stroke, multiple sclerosis and traumatic brain or spinal cord injury. Common treatments for spasticity include physical and occupational therapy as well as oral medications such as baclofen, injected medications such as botulinum neurotoxin, intrathecal medications and surgical procedures. The approach to the treatment of spasticity is comprehensive in nature and these therapies have been widely applied to a broad population of patients including children, adults and older adults.
This is a single-center, randomized, prospective, parallel, double-blind study. Study duration is approximately 16 weeks.At Visit 2 (Baseline Visit), all eligible study subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo, or intramuscular placebo plus oral baclofen.
- Conditions
- Spasticity
- Being tested
- intramuscular Botox versus oral baclofen
- Keywords
- spasticity, Botox, baclofen
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular Botox versus oral baclofenDrug
Each vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This study will explore the safety and effectiveness of Botox versus baclofen in treatment subjects with upper-limb spasticity due to neurological damage or a stable neurological disorder. Subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen. Receives: Drug: intramuscular Botox versus oral baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Assessment Scale (DAS)
Measured: 4 months
Secondary outcomes (4)
Modified Ashworth Tone
Measured: 4 months
Subject Questionnaires
Measured: 4 months
Contralateral Finger Tap Test
Measured: 4 months
Contralateral Grip Strength
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: low patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Charles, Vanderbilt University
- Investigators
- P. David Charles, MD, Principal investigator, Vanderbilt University Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280280
- Sponsor's protocol ID
- 050935
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2006
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study
- ClinicalTrials.gov ID
- NCT00280280
- Acronym / sponsor ID
- 050935
- Conditions
- Spasticity
- Keywords
- spasticity, Botox, baclofen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low patient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Jan 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.
The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance.
Detailed description
Spasticity results from any injury to the central nervous system, including brain or spinal cord. Illnesses or injuries that typically cause spasticity include cerebral palsy, stroke, multiple sclerosis and traumatic brain or spinal cord injury. Common treatments for spasticity include physical and occupational therapy as well as oral medications such as baclofen, injected medications such as botulinum neurotoxin, intrathecal medications and surgical procedures. The approach to the treatment of spasticity is comprehensive in nature and these therapies have been widely applied to a broad population of patients including children, adults and older adults.
This is a single-center, randomized, prospective, parallel, double-blind study. Study duration is approximately 16 weeks.At Visit 2 (Baseline Visit), all eligible study subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo, or intramuscular placebo plus oral baclofen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: intramuscular Botox versus oral baclofenThis study will explore the safety and effectiveness of Botox versus baclofen in treatment subjects with upper-limb spasticity due to neurological damage or a stable neurological disorder. Subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient, male or female subjects of any race, and at least 18 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 50mlU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study;
- Minimal 4-month history stable neurological disorder resulting focal upper limb muscle spasticity (wrist and/or elbow)
- Disability Assessment Scale (DAS) ≥ 2 for the principal therapeutic intervention target as chosen by Investigator and Subject (i.e., hygiene, dressing, pain and cosmesis).
- Subjects who are able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
Key exclusion criteria (16 listed)
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and are not practicing a reliable method of birth control.
- Severe contracture at the wrist or a history of tendon transfer in the study limb.
- Cast of study limb within four weeks of Visit 1.
- Profound atrophy of the muscles in the target area(s) of injection.
- Progressive neurological disorder (e.g., multiple sclerosis).
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 |
|---|---|---|
| intramuscular Botox versus oral baclofenEach vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets. | Drug | 1 |
Primary outcome
Disability Assessment Scale (DAS)
Time frame: 4 months
4 secondary outcomes
Modified Ashworth Tone
Time frame: 4 months
Subject Questionnaires
Time frame: 4 months
Contralateral Finger Tap Test
Time frame: 4 months
Contralateral Grip Strength
Time frame: 4 months
Results and safety
The study was stopped early (reason given: low patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
P. David Charles, MD principal investigator
Vanderbilt University Department of Neurology
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 intramuscular Botox versus oral baclofen in people with Spasticity, run by Vanderbilt University 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 16 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 20 Jan 2012. 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?
The study was stopped early (reason given: low patient accrual). Results are not available in the source record.
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?
Disability Assessment Scale (DAS) (time frame: 4 months). 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 20 Jan 2012.