Stiff Knee GaitNCT00900666
Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury
A study testing botulinum toxin A (BTX-A) in people with Stiff Knee Gait and Brain Injuries, run by Mary Free Bed Rehabilitation Hospital at 1 site in United States.
Trial summary
Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait deviation is characterized by reduced knee flexion during swing phase of the gait cycle and adversely impacts safe foot clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stiff Knee Gait, Brain Injuries
- What is being tested?
- botulinum toxin A (BTX-A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 6 months post-acquired brain injury
- Male or female subjects, at least 18 years of age
- Independent ambulation with or without assistive device or orthotic device
- Cognitive Rancho Level VI or higher, ability to follow directions, and likely to complete all required visits
- At least 100 degrees of passive knee flexion ROM
- Gait velocity greater than or equal to 0.4 m/sec
Show all 11Show fewer
- Modified Ashworth scale rating of 1+ or higher for RF spasticity
- Written informed consent and/or assent has been obtained
- Meet criteria for stiff knee gait based on baseline computerized gait analysis data less than 2 weeks prior to receiving intervention, including:
- Peak knee flexion less than or equal to 50 degrees (or > 2 standard deviations below normal adult peak knee flexion)
- Peak knee flexion velocity less than or equal to 256 degrees/% gait cycle (or > 2 standard deviations below normal peak knee flexion velocity)
Who cannot join
- Change in spasticity medications during course of the study
- Ankle plantarflexion contracture greater than 0 degrees
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
- Has had treatment with botulinum toxin of any serotype to RF or gastrocsoleus up to 12 months prior to enrollment in study
- Evidence of current alcohol or drug abuse or history of neuropsychiatric condition not related to ABI
- Concurrent participation in another investigational drug or device study up to12 months prior to enrollment in study
Show all 11Show fewer
- Infection or skin disorder at an anticipated injection site
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Known allergy or sensitivity to any of the components in the study medication, including human serum albumin and sodium chloride as well as the botulinum toxin protein
- Any medical condition that may put the subject at increased risk with exposure to BOTOX including, but not limited to, diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, peripheral neuropathy or any other disorder that might interfere with neuromuscular function
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Free Bed Rehabilitation Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: Randomized Controlled Trial on the Effects of Botulinum Toxin Injections in the Rectus Femoris on Gait Function in Stiff Knee Gait Following Acquired Brain Injury
Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait deviation is characterized by reduced knee flexion during swing phase of the gait cycle and adversely impacts safe foot clearance. Stiff knee gait is an inefficient gait pattern and slows walking speed, limiting one's ability to adapt walking to community mobility demands. Fall risk is increased with this gait problem due to low or ineffective foot clearance. Common compensatory strategies are employed, such as circumduction, hip hiking or vaulting, during ambulation.
The purpose of this study is to examine both the immediate (one month post-injection) and longer-term (4 months post-injection) effects of botulinum toxin injections to the rectus femoris (RF) on gait function in persons with brain injury. This study is clinically important to help inform rehabilitation professionals regarding treatment decisions for management of inefficient and often unsafe stiff knee gait problems following brain injury.
Read more
Research Questions:
- Is there a statistically significant difference in mean peak knee flexion between the experimental and control group?
- Is there a statistically significant difference in mean peak knee velocity during the preswing and initial swing phases of gait between the experimental and control group?
- Is there a statistically significant difference in gait function (based on 6-Minute Walk time and temporal distance measures) between the experimental and control group?
Read the detailed description
Pathophysiologic factors that may contribute to stiff knee gait in persons with brain injury are muscle hypertonicity of the quadriceps muscles, hip flexor weakness, and over activity of the gastrocsoleus muscles in terminal stance(1). Kerrigan et al (2) reported that hyperactivity of the Rectus Femoris (RF) during swing phase was a key contributor to this dynamic swing phase deficit in adults with spastic paresis. Overactivity of the RF muscle during early swing phase has also been identified as a major contributor to stiff knee gait dysfunction in children with cerebral palsy (3). Recognition of the role of RF over-activity in stiff knee gait in the cerebral palsy population has led to surgical and medical interventions aimed to minimize this constraint on swing phase mechanics, such as RF transfers, RF release, and Botulinum toxin injections (BTX-A)(4,5). Research in the cerebral palsy population supports the application of these interventions to improve knee flexion during swing phase and improve overall gait function and efficiency (6).
The applicability of these directed interventions for stiff knee gait, particularly the less invasive BTX-A injections to RF, has not been well examined in adults with spastic paresis. Two research groups (7,8) examined the immediate effects of a motor branch block of RF in persons post-stroke with stiff knee gait and reported improved maximum knee flexion and mean knee flexion velocity during preswing and swing phase following the block. Very few studies9,10 to date examined the short-term effects of BTX-A injection to RF on gait function and energy cost during walking in persons post-stroke who ambulated with stiff knee gait. Stoquart and colleagues9 found that at two months following BTX-A injections, subjects had improved maximum knee flexion during swing phase and improved knee flexion velocity during toe off. Energy cost improved only in that subset of subjects who had greater than 10 degrees of knee flexion during swing phase prior to BTX-A injections. The results of this prospective observational study provided initial support for the efficacy of BTX-A intervention for stiff knee gait in adults post-stroke, however, the authors only examined the short-term effects of this intervention(9). Also, this study had limitations in its methodology, as gait function pre- and post-BOTOX® intervention was assessed using an automated treadmill as opposed to gait analysis during overground walking at self selected gait speed. Further research is needed to determine if there is longer-term benefit of BTX-A injections to RF on gait function in the brain injury population.
Research Design:
- Double-blind randomized controlled trial
- Subjects will be randomly assigned to experimental or control group
- The experimental group will receive BTX-A injection to rectus femoris (RF) followed by usual care
- The control group will receive saline injection to RF followed by usual care
- Subjects and researchers will be blinded to group assignment
- Three-dimensional computerized gait assessments will be conducted pre-treatment (within 2 weeks prior to BOTOX®/placebo injection), 1 month post and 4 months post-injection
- Conditions
- Stiff Knee Gait, Brain Injuries
- Being tested
- placebo, botulinum toxin A (BTX-A)
- Keywords
- Stiff knee gait, Gait analysis, Traumatic Brain Injury, Acquired Brain Injury
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
botulinum toxin A (BTX-A)Drug
200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
| Study group | Role | What they receive |
|---|---|---|
| Saline injection | Placebo comparator | Not described Receives: Drug: placebo |
| Botulinum toxin injection | Experimental | Not described Receives: Drug: botulinum toxin A (BTX-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Knee Flexion During Swing Phase of Gait
Measured via computerized gait analysis, the average of peak knee flexion during swing phase.
Measured: baseline, 1-month and 4-month post-injection
Secondary outcomes (1)
Gait Function (Based on 6-Minute Walk)
Average walking speed as calculated during a 6-min walk
Measured: baseline, 1-mo and 4-mo post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionDec 2011
Why it stopped: Original subject recruitment goal was unrealistic. Study was terminated at N=19.
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.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stiff Knee GaitStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Free Bed Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Krisanne B. Chapin, PhD, Mary Free Bed Rehabilitation Hospital
- Investigators
- Krisanne B Chapin, PhD, Principal investigator, Mary Free Bed Rehabilitation HospitalCathy Harro, PT, MS, NCS, Principal investigator, Grand Valley State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900666
- Sponsor's protocol ID
- MFB2008.08
- Status last verified
- May 2013
- First submitted
- 12 May 2009
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
1. Perry J. Gait Analysis: Normal and Pathological Function. 1st Ed. Thorofare, NJ: SLACK Incorporated; 1992.
Kerrigan DC, Gronley J, Perry J. Stiff-legged gait in spastic paresis. A study of quadriceps and hamstrings muscle activity. Am J Phys Med Rehabil. 1991 Dec;70(6):294-300.
PubMed 1741998Sutherland DH, Davids JR. Common gait abnormalities of the knee in cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):139-47.
PubMed 8458127Perry J. Distal rectus femoris transfer. Dev Med Child Neurol. 1987 Apr;29(2):153-8. doi: 10.1111/j.1469-8749.1987.tb02130.x.
PubMed 3582785Ward AB, Molenaers G, Colosimo C, Berardelli A. Clinical value of botulinum toxin in neurological indications. Eur J Neurol. 2006 Dec;13 Suppl 4:20-6. doi: 10.1111/j.1468-1331.2006.01650.x.
PubMed 17112346Cosgrove AP, Corry IS, Graham HK. Botulinum toxin in the management of the lower limb in cerebral palsy. Dev Med Child Neurol. 1994 May;36(5):386-96. doi: 10.1111/j.1469-8749.1994.tb11864.x.
PubMed 8168657Chantraine F, Detrembleur C, Lejeune TM. Effect of the rectus femoris motor branch block on post-stroke stiff-legged gait. Acta Neurol Belg. 2005 Sep;105(3):171-7.
PubMed 16255155Sung DH, Bang HJ. Motor branch block of the rectus femoris: its effectiveness in stiff-legged gait in spastic paresis. Arch Phys Med Rehabil. 2000 Jul;81(7):910-5. doi: 10.1053/apmr.2000.5615.
PubMed 10896003Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
PubMed 18164331
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effects of Botulinum Toxin Injections in the Rectus Femoris on Gait Function in Stiff Knee Gait Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT00900666
- Acronym / sponsor ID
- MFB2008.08
- Conditions
- Stiff Knee Gait, Brain Injuries
- Keywords
- Stiff knee gait, Gait analysis, Traumatic Brain Injury, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original subject recruitment goal was unrealistic. Study was terminated at N=19.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mary Free Bed Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait deviation is characterized by reduced knee flexion during swing phase of the gait cycle and adversely impacts safe foot clearance. Stiff knee gait is an inefficient gait pattern and slows walking speed, limiting one's ability to adapt walking to community mobility demands. Fall risk is increased with this gait problem due to low or ineffective foot clearance. Common compensatory strategies are employed, such as circumduction, hip hiking or vaulting, during ambulation.
The purpose of this study is to examine both the immediate (one month post-injection) and longer-term (4 months post-injection) effects of botulinum toxin injections to the rectus femoris (RF) on gait function in persons with brain injury. This study is clinically important to help inform rehabilitation professionals regarding treatment decisions for management of inefficient and often unsafe stiff knee gait problems following brain injury.
Research Questions:
- Is there a statistically significant difference in mean peak knee flexion between the experimental and control group?
- Is there a statistically significant difference in mean peak knee velocity during the preswing and initial swing phases of gait between the experimental and control group?
- Is there a statistically significant difference in gait function (based on 6-Minute Walk time and temporal distance measures) between the experimental and control group?
Detailed description
Pathophysiologic factors that may contribute to stiff knee gait in persons with brain injury are muscle hypertonicity of the quadriceps muscles, hip flexor weakness, and over activity of the gastrocsoleus muscles in terminal stance(1). Kerrigan et al (2) reported that hyperactivity of the Rectus Femoris (RF) during swing phase was a key contributor to this dynamic swing phase deficit in adults with spastic paresis. Overactivity of the RF muscle during early swing phase has also been identified as a major contributor to stiff knee gait dysfunction in children with cerebral palsy (3). Recognition of the role of RF over-activity in stiff knee gait in the cerebral palsy population has led to surgical and medical interventions aimed to minimize this constraint on swing phase mechanics, such as RF transfers, RF release, and Botulinum toxin injections (BTX-A)(4,5). Research in the cerebral palsy population supports the application of these interventions to improve knee flexion during swing phase and improve overall gait function and efficiency (6).
The applicability of these directed interventions for stiff knee gait, particularly the less invasive BTX-A injections to RF, has not been well examined in adults with spastic paresis. Two research groups (7,8) examined the immediate effects of a motor branch block of RF in persons post-stroke with stiff knee gait and reported improved maximum knee flexion and mean knee flexion velocity during preswing and swing phase following the block. Very few studies9,10 to date examined the short-term effects of BTX-A injection to RF on gait function and energy cost during walking in persons post-stroke who ambulated with stiff knee gait. Stoquart and colleagues9 found that at two months following BTX-A injections, subjects had improved maximum knee flexion during swing phase and improved knee flexion velocity during toe off. Energy cost improved only in that subset of subjects who had greater than 10 degrees of knee flexion during swing phase prior to BTX-A injections. The results of this prospective observational study provided initial support for the efficacy of BTX-A intervention for stiff knee gait in adults post-stroke, however, the authors only examined the short-term effects of this intervention(9). Also, this study had limitations in its methodology, as gait function pre- and post-BOTOX® intervention was assessed using an automated treadmill as opposed to gait analysis during overground walking at self selected gait speed. Further research is needed to determine if there is longer-term benefit of BTX-A injections to RF on gait function in the brain injury population.
Research Design:
- Double-blind randomized controlled trial
- Subjects will be randomly assigned to experimental or control group
- The experimental group will receive BTX-A injection to rectus femoris (RF) followed by usual care
- The control group will receive saline injection to RF followed by usual care
- Subjects and researchers will be blinded to group assignment
- Three-dimensional computerized gait assessments will be conducted pre-treatment (within 2 weeks prior to BOTOX®/placebo injection), 1 month post and 4 months post-injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline injection | Placebo comparator | Drug: placebo |
| Botulinum toxin injection | Experimental | Drug: botulinum toxin A (BTX-A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Greater than 6 months post-acquired brain injury
- Male or female subjects, at least 18 years of age
- Independent ambulation with or without assistive device or orthotic device
- Cognitive Rancho Level VI or higher, ability to follow directions, and likely to complete all required visits
- At least 100 degrees of passive knee flexion ROM
Key exclusion criteria (11 listed)
- Change in spasticity medications during course of the study
- Ankle plantarflexion contracture greater than 0 degrees
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
- Has had treatment with botulinum toxin of any serotype to RF or gastrocsoleus up to 12 months prior to enrollment in study
- Evidence of current alcohol or drug abuse or history of neuropsychiatric condition not related to ABI
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 |
|---|---|---|
| placeboA total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb. | Drug | Saline injection |
| botulinum toxin A (BTX-A)200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle. | Drug | Botulinum toxin injection |
Primary outcome
Mean Peak Knee Flexion During Swing Phase of Gait
Time frame: baseline, 1-month and 4-month post-injection
Measured via computerized gait analysis, the average of peak knee flexion during swing phase.
1 secondary outcome
Gait Function (Based on 6-Minute Walk)
Time frame: baseline, 1-mo and 4-mo post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1. Perry J. Gait Analysis: Normal and Pathological Function. 1st Ed. Thorofare, NJ: SLACK Incorporated; 1992.
- Background: PubMed 1741998Kerrigan DC, Gronley J, Perry J. Stiff-legged gait in spastic paresis. A study of quadriceps and hamstrings muscle activity. Am J Phys Med Rehabil. 1991 Dec;70(6):294-300.
- Background: PubMed 8458127Sutherland DH, Davids JR. Common gait abnormalities of the knee in cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):139-47.
- Background: PubMed 3582785Perry J. Distal rectus femoris transfer. Dev Med Child Neurol. 1987 Apr;29(2):153-8. doi: 10.1111/j.1469-8749.1987.tb02130.x.
- Background: PubMed 17112346Ward AB, Molenaers G, Colosimo C, Berardelli A. Clinical value of botulinum toxin in neurological indications. Eur J Neurol. 2006 Dec;13 Suppl 4:20-6. doi: 10.1111/j.1468-1331.2006.01650.x.
- Background: PubMed 8168657Cosgrove AP, Corry IS, Graham HK. Botulinum toxin in the management of the lower limb in cerebral palsy. Dev Med Child Neurol. 1994 May;36(5):386-96. doi: 10.1111/j.1469-8749.1994.tb11864.x.
- Background: PubMed 16255155Chantraine F, Detrembleur C, Lejeune TM. Effect of the rectus femoris motor branch block on post-stroke stiff-legged gait. Acta Neurol Belg. 2005 Sep;105(3):171-7.
- Background: PubMed 10896003Sung DH, Bang HJ. Motor branch block of the rectus femoris: its effectiveness in stiff-legged gait in spastic paresis. Arch Phys Med Rehabil. 2000 Jul;81(7):910-5. doi: 10.1053/apmr.2000.5615.
- Background: PubMed 18164331Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
Related trials for Stiff Knee Gait
RecruitingObservational study
Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait
Botulinum Toxin Injection, Stiff Knee Gait
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.
Krisanne B Chapin, PhD principal investigator
Mary Free Bed Rehabilitation Hospital
Cathy Harro, PT, MS, NCS principal investigator
Grand Valley State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin A (BTX-A) in people with Stiff Knee Gait and Brain Injuries, run by Mary Free Bed Rehabilitation Hospital 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 11 inclusion and 11 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 24 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 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?
Mean Peak Knee Flexion During Swing Phase of Gait (time frame: baseline, 1-month and 4-month post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900666, which also lists 9 linked publications.
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 24 Jun 2013.