Cerebrovascular AccidentPhase 3NCT02586142
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
A Phase 3 study testing Botulinum Toxin Type A and Stretching exercise in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Claw toes deformity result in spasticity often seem in patients with central nerve disease. It also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. There are few relative reports about the Botulinum toxin type A (BTX-A) injection on claw toe. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Botulinum Toxin Type A and Stretching exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Jul 2013
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with spasticity toe clawing(metatarsophalange jointextension, proximal and distal phalange joint flexion)
- MAS scale of metatarsophalange joint and interphalangeal joint more than 2
- Pain during walking, abnormal gait patterns and can't wear shoess due to claw toe
- Haven't received botox or phenol or alcohol injections before
Who cannot join
- Lower extremities joint contrature, bone deformity
- Had received botox injections or phenol injections or before due to lower extremities spasticity
- Combine other neuromuscular system disease
- Severe cognition disorder or aphasia after stroke
- Significant atrophy of flexor digitorum longus and brevis
- Allergy to botox
Show all 9Show fewer
- Infection on injection site
- Have systemic infection
- Now accept aminioglycoside or other medicine will affect neuromusclar transition
Trial locations and contacts
1 site in 1 country.
About this study
Claw toes deformity result in spasticity often seem in patients with central nerve disease. It also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. There are few relative reports about the Botulinum toxin type A (BTX-A) injection on claw toe. The investigators' study has two main purposes:
- assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes.
- assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.
Read the detailed description
The investigators will enroll 50 hemiplegic stroke patients met the inclusion criteria(onset more than 6 month, lower extremity Brunnstrome stage more than stage IV, walking without assistance devices and pain during walking due to claw toe. The investigators will focus and inject BTX-A with ultrasonographyic guidance on flexor digitorum longus and brevis(both 50 unit). If patients combine ankle plantar flexors spasticity, the investigators will inject another 50 unit on both the medial and lateral head of gastrocnemius . Every patients will receive regular stretching exercise in hospital and do self stretching exercise at home for 3 months after injection. Patients will be evaluated at 2 weeks, 4 weeks and 12 weeks, 24 weeks and 1 year after injection. Outcome measure include severity of spasticity and pain, sensory and motor function, range of motion, functional assessment of lower extremity and analyze pressure under foot.
- Conditions
- Cerebrovascular Accident
- Being tested
- Botulinum Toxin Type A, Stretching exercise
- Keywords
- spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise
- Medical subject headings
- Stroke, Muscle Spasticity, Hammer Toe Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botulinum toxin
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Stretching exerciseOther
After accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(BTX-A) injection | Experimental | To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance. Receives: Drug: Botulinum Toxin Type A |
| BTX-A injection plus stretching exercise | Active comparator | Inject Botulinum toxin type A on the spasticity lower extremity for participants by ultrasounds guidance. After injection, arrange them to receive stretching exercise in Kaoshiung Chang Gung Memorial Hospital 3 time per week for 3 months. Receives: Drug: Botulinum Toxin Type A; Other: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity severity scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=none, 1=mild, 2= median, 3=severe
Measured: Change from Baseline data at 1 year
Secondary outcomes (14)
Sensory function scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no feeling, 1=abnormal, 2= normal
Measured: Change from Baseline data at 1 year
Brunnstrome stage
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Manual muscle test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection including toe flexion/ extension, ankle plantar flexion/ dorsiflexion
Measured: Change from Baseline data at 1 year
Functional ambulation classification scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Active range of motion measured by goniometer
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Modified Ashworth scale(MAS)
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Pain severity measurement recorded by VAS
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no pain; 100=maximum
Measured: Change from Baseline data at 1 year
To develop a questionnaire (ABILOCO questionnaire)
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection.
Its a Rasch-built 13-item questionnaire to assess locomotion ability in stroke patients.
Measured: Change from Baseline data at 1 year
Berg Balance test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Get up and go test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
10-meter walking test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Fugl-Meyer Assessment
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Barthel Index
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
6 minute walking test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Measured: Change from Baseline data at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pong Ya-Ping, MD, Study chair, Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586142
- Sponsor's protocol ID
- NMRPG890041
- Status last verified
- Aug 2010
- First submitted
- 12 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yelnik AP, Bonan IV. [Post stroke hemiplegia: lower limb benefit from botulinum toxin (review)]. Ann Readapt Med Phys. 2003 Jul;46(6):281-5. doi: 10.1016/s0168-6054(03)00111-9. French.
PubMed 12928130Rivera-Dominguez M, DiBenedetto M, Frisbie JH, Rossier AB. Pes cavus and claw toes deformity in patients with spinal cord injury and multiple sclerosis. Paraplegia. 1979 Feb;16(4):375-82. doi: 10.1038/sc.1978.71.
PubMed 431969Mizel MS, Yodlowski ML. Disorders of the Lesser Metatarsophalangeal Joints. J Am Acad Orthop Surg. 1995 May;3(3):166-173. doi: 10.5435/00124635-199505000-00006.
PubMed 10790665Feeney MS, Williams RL, Stephens MM. Selective lengthening of the proximal flexor tendon in the management of acquired claw toes. J Bone Joint Surg Br. 2001 Apr;83(3):335-8. doi: 10.1302/0301-620x.83b3.11506.
PubMed 11341415Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg. 2004 May;187(5A):17S-24S. doi: 10.1016/S0002-9610(03)00297-6.
PubMed 15147987Myerson MS, Shereff MJ. The pathological anatomy of claw and hammer toes. J Bone Joint Surg Am. 1989 Jan;71(1):45-9.
PubMed 2913002Truckenbrodt H, Hafner R, von Altenbockum C. Functional joint analysis of the foot in juvenile chronic arthritis. Clin Exp Rheumatol. 1994 Sep-Oct;12 Suppl 10:S91-6.
PubMed 7955636Cyphers SM, Feiwell E. Review of the Girdlestone-Taylor procedure for clawtoes in myelodysplasia. Foot Ankle. 1988 Apr;8(5):229-33. doi: 10.1177/107110078800800501.
PubMed 3366427Bernbach EH, Bernbach MR. A box joint arthrodesis for the proximal interphalangeal joint in claw toe deformity. J Am Podiatr Med Assoc. 1985 Nov;75(11):575-80. doi: 10.7547/87507315-75-11-575. No abstract available.
PubMed 4067859Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91.
PubMed 9826983Gajiwala KJ, Sams SB, Pandya N, Wagh A. A new dynamic lumbrical simulating splint for claw hand deformity. Plast Reconstr Surg. 1991 Jan;87(1):170-3. doi: 10.1097/00006534-199101000-00030.
PubMed 1984264Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120.
PubMed 9826984O'Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S182-90. doi: 10.1097/00002508-200211001-00011.
PubMed 12569967Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702.
PubMed 15201348Korelitz BI, Sommers SC. Responses to drug therapy in ulcerative colitis. Evaluation by rectal biopsy and histopathological changes. Am J Gastroenterol. 1975 Nov;64(5):365-70.
PubMed 2008
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
- ClinicalTrials.gov ID
- NCT02586142
- Acronym / sponsor ID
- NMRPG890041
- Conditions
- Cerebrovascular Accident
- Keywords
- spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Oct 2015 (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.
Claw toes deformity result in spasticity often seem in patients with central nerve disease. It also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. There are few relative reports about the Botulinum toxin type A (BTX-A) injection on claw toe. The investigators' study has two main purposes:
- assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes.
- assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.
Detailed description
The investigators will enroll 50 hemiplegic stroke patients met the inclusion criteria(onset more than 6 month, lower extremity Brunnstrome stage more than stage IV, walking without assistance devices and pain during walking due to claw toe. The investigators will focus and inject BTX-A with ultrasonographyic guidance on flexor digitorum longus and brevis(both 50 unit). If patients combine ankle plantar flexors spasticity, the investigators will inject another 50 unit on both the medial and lateral head of gastrocnemius . Every patients will receive regular stretching exercise in hospital and do self stretching exercise at home for 3 months after injection. Patients will be evaluated at 2 weeks, 4 weeks and 12 weeks, 24 weeks and 1 year after injection. Outcome measure include severity of spasticity and pain, sensory and motor function, range of motion, functional assessment of lower extremity and analyze pressure under foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A(BTX-A) injection | Experimental | Drug: Botulinum Toxin Type ATo inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance. |
| BTX-A injection plus stretching exercise | Active comparator | Drug: Botulinum Toxin Type A, Other: Stretching exerciseInject Botulinum toxin type A on the spasticity lower extremity for participants by ultrasounds guidance. After injection, arrange them to receive stretching exercise in Kaoshiung Chang Gung Memorial Hospital 3 time per week for 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with spasticity toe clawing(metatarsophalange jointextension, proximal and distal phalange joint flexion)
- MAS scale of metatarsophalange joint and interphalangeal joint more than 2
- Pain during walking, abnormal gait patterns and can't wear shoess due to claw toe
- Haven't received botox or phenol or alcohol injections before
Key exclusion criteria (9 listed)
- Lower extremities joint contrature, bone deformity
- Had received botox injections or phenol injections or before due to lower extremities spasticity
- Combine other neuromuscular system disease
- Severe cognition disorder or aphasia after stroke
- Significant atrophy of flexor digitorum longus and brevis
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: Botulinum toxinTo inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance. | Drug | BTX-A injection plus stretching exercise, Botulinum toxin type A(BTX-A) injection |
| Stretching exerciseAfter accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month. | Other | BTX-A injection plus stretching exercise |
Primary outcome
Spasticity severity scale
Time frame: Change from Baseline data at 1 year
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=none, 1=mild, 2= median, 3=severe
14 secondary outcomes
Sensory function scale
Time frame: Change from Baseline data at 1 year
Brunnstrome stage
Time frame: Change from Baseline data at 1 year
Manual muscle test
Time frame: Change from Baseline data at 1 year
Functional ambulation classification scale
Time frame: Change from Baseline data at 1 year
Active range of motion measured by goniometer
Time frame: Change from Baseline data at 1 year
Modified Ashworth scale(MAS)
Time frame: Change from Baseline data at 1 year
Pain severity measurement recorded by VAS
Time frame: Change from Baseline data at 1 year
To develop a questionnaire (ABILOCO questionnaire)
Time frame: Change from Baseline data at 1 year
Berg Balance test
Time frame: Change from Baseline data at 1 year
Get up and go test
Time frame: Change from Baseline data at 1 year
10-meter walking test
Time frame: Change from Baseline data at 1 year
Fugl-Meyer Assessment
Time frame: Change from Baseline data at 1 year
Barthel Index
Time frame: Change from Baseline data at 1 year
6 minute walking test
Time frame: Change from Baseline data at 1 year
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 26 Oct 2015.
- Background: PubMed 12928130Yelnik AP, Bonan IV. [Post stroke hemiplegia: lower limb benefit from botulinum toxin (review)]. Ann Readapt Med Phys. 2003 Jul;46(6):281-5. doi: 10.1016/s0168-6054(03)00111-9. French.
- Background: PubMed 431969Rivera-Dominguez M, DiBenedetto M, Frisbie JH, Rossier AB. Pes cavus and claw toes deformity in patients with spinal cord injury and multiple sclerosis. Paraplegia. 1979 Feb;16(4):375-82. doi: 10.1038/sc.1978.71.
- Background: PubMed 10790665Mizel MS, Yodlowski ML. Disorders of the Lesser Metatarsophalangeal Joints. J Am Acad Orthop Surg. 1995 May;3(3):166-173. doi: 10.5435/00124635-199505000-00006.
- Background: PubMed 11341415Feeney MS, Williams RL, Stephens MM. Selective lengthening of the proximal flexor tendon in the management of acquired claw toes. J Bone Joint Surg Br. 2001 Apr;83(3):335-8. doi: 10.1302/0301-620x.83b3.11506.
- Background: PubMed 15147987Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg. 2004 May;187(5A):17S-24S. doi: 10.1016/S0002-9610(03)00297-6.
- Background: PubMed 2913002Myerson MS, Shereff MJ. The pathological anatomy of claw and hammer toes. J Bone Joint Surg Am. 1989 Jan;71(1):45-9.
- Background: PubMed 7955636Truckenbrodt H, Hafner R, von Altenbockum C. Functional joint analysis of the foot in juvenile chronic arthritis. Clin Exp Rheumatol. 1994 Sep-Oct;12 Suppl 10:S91-6.
- Background: PubMed 3366427Cyphers SM, Feiwell E. Review of the Girdlestone-Taylor procedure for clawtoes in myelodysplasia. Foot Ankle. 1988 Apr;8(5):229-33. doi: 10.1177/107110078800800501.
- Background: PubMed 4067859Bernbach EH, Bernbach MR. A box joint arthrodesis for the proximal interphalangeal joint in claw toe deformity. J Am Podiatr Med Assoc. 1985 Nov;75(11):575-80. doi: 10.7547/87507315-75-11-575. No abstract available.
- Background: PubMed 9826983Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91.
- Background: PubMed 1984264Gajiwala KJ, Sams SB, Pandya N, Wagh A. A new dynamic lumbrical simulating splint for claw hand deformity. Plast Reconstr Surg. 1991 Jan;87(1):170-3. doi: 10.1097/00006534-199101000-00030.
- Background: PubMed 9826984Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120.
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Pong Ya-Ping, MD study chair
Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A and Stretching exercise in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 9 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 26 Oct 2015. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Spasticity severity scale (time frame: Change from Baseline data at 1 year). 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 NCT02586142, which also lists 26 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 26 Oct 2015.