HemiplegiaPhase 3NCT00276185
HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
A Phase 3 study testing Time delay treatment of botulinum toxin in people with Hemiplegia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Time delay treatment of botulinum toxin
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age 18
- Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
- Antispasticity medication stabilized for the last 30 days
- Severe cognitive impairment such that patient is unable to provide scale assessment.
- Significant spasticity impeding improvement by re-education for 2 months or less
- Lack of muscular retraction defined by a minimal range of articular motion as :
Show all 12Show fewer
- finger : complete extension and rolling up
- wrist : extension 40°/flexion : 45°
- elbow : extension - 10°/flexion : 120°
- shoulder : Enjalbert score 2 or more
- Antagonist muscles (to spasticity) activity score 1 or more
- Social Security benefits
Who cannot join
- Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
- Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
- Absence of mobility in proximal part of upper limb that does not predict a functional gain
- Minor stroke with non-disabling deficit or rapidly improving motor symptoms
- other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
- Treatment of spasticity by previous administration of botulinum toxin, if known
- Known allergy to botulinum toxin
- Currently participating in other research studies
Trial locations and contacts
1 site in 1 country.
Franck Durif contact
France1 site, 1 recruiting
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
Franck Durif, (33) 04 73 750 750
About this study
Official title: Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).
- Conditions
- Hemiplegia
- Being tested
- Time delay treatment of botulinum toxin
- Keywords
- spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time delay treatment of botulinum toxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Box and blocks test
Enjalbert test
Modified Ashworth scale (upper limb)
Functional Independence Measure
Fugl-Meyer upper limb test
Clinical Global Impression (CGI)
36-Item Short Form (SF-36) quality of life
Secondary outcomes (2)
Range of pain
Individual functional kinesitherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- J. Rebeyrol Hospital in Limoges, Rennes University Hospital, Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes), Saint Jacques Hospital in Nantes, Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Angers, Centre Hospitalier Universitaire de Besancon
- Investigators
- Franck Durif, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276185
- Sponsor's protocol ID
- CHU63-0003
- Status last verified
- Jan 2011
- First submitted
- 12 Jan 2006
- Last updated
- 19 Jan 2011
- Results posted
- No
Publications
Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9. doi: 10.1016/s0885-3924(00)00146-9.
PubMed 10946168
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
- ClinicalTrials.gov ID
- NCT00276185
- Acronym / sponsor ID
- CHU63-0003
- Conditions
- Hemiplegia
- Keywords
- spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- J. Rebeyrol Hospital in Limoges, Rennes University Hospital, Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes), Saint Jacques Hospital in Nantes, Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Angers, Centre Hospitalier Universitaire de Besancon
- Study start
- Dec 2005
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 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.
Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Minimum age 18
- Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
- Antispasticity medication stabilized for the last 30 days
- Severe cognitive impairment such that patient is unable to provide scale assessment.
- Significant spasticity impeding improvement by re-education for 2 months or less
Key exclusion criteria (8 listed)
- Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
- Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
- Absence of mobility in proximal part of upper limb that does not predict a functional gain
- Minor stroke with non-disabling deficit or rapidly improving motor symptoms
- other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
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 |
|---|---|---|
| Time delay treatment of botulinum toxin | Drug | – |
Primary outcome
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Box and blocks test
Enjalbert test
Modified Ashworth scale (upper limb)
Functional Independence Measure
Fugl-Meyer upper limb test
Clinical Global Impression (CGI)
36-Item Short Form (SF-36) quality of life
2 secondary outcomes
Range of pain
Individual functional kinesitherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
- Results publication: PubMed 10946168Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9. doi: 10.1016/s0885-3924(00)00146-9.
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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.
Franck Durif contact
Franck Durif principal investigator
University Hospital, Clermont-Ferrand
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 Time delay treatment of botulinum toxin in people with Hemiplegia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 12 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Jan 2011. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franck Durif ((33) 04 73 750 750), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;. The study lists 8 primary outcomes in all. 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 NCT00276185, which also lists 1 linked publication.
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 19 Jan 2011.