Cerebral PalsyPhase 4NCT00432055
Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
A Phase 4 study testing Botulinum toxin type A (Botox) in people with Cerebral Palsy, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum toxin type A (Botox)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Jan 2009
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral spastic CP
- Modified Ashworth Scale (MAS) ≥ 2 in ankle- or knee joint muscles.
- ≥ 18 year of age, ≤ 65 year of age
- Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.
Who cannot join
- Cognitive impairment.
- No spasticity (MAS < 2 )
- < 18 year of age
- Not ambulant without walking aids
- Pregnant or planning pregnancy
- Btx-A treatment last 6 months
Show all 10Show fewer
- Orthopedic surgery lower extremity last 18 months
- Obvious skeletal/joint deformity where orthopedic surgery is indicated
- Other diseases which can affect level of function (rheumatoid or neurological )
- New treatment the past four weeks which affect the musculoskeletal system (pain killers, physical therapy, acupuncture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.
Read the detailed description
Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia
There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.
Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum toxin type A (Botox), placebo (saline)
- Keywords
- Adult, Cerebral Palsy, Spastic contractures, Botulinum toxin type A
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A (Botox)Drug
placebo (saline)Drug
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Botox Receives: Drug: Botulinum toxin type A (Botox) |
| II | Placebo comparator | Not described Receives: Drug: placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
Measured: 8 week
Summary measure of health related quality of life (SF-36)
Measured: 8 week , 16 week
Secondary outcomes (10)
Stiffness/spasticity according to VAS
Measured: 8 week, 16 week
Questionnaire gait function
Measured: 8 week, 16 week
Spasticity in ankle, knee and hip according to Modified Ashworth Scale
Measured: 8 week,
3D-gait data (Kinetics,Temporospatial (stride length, velocity)
Measured: 8 week
Global Scale
Measured: 8 week, 16 week
Timed Up and Go
Measured: 8 week
6 minutes walking test
Measured: 8 week
Registrations of sample characteristics
Measured: 0 week
Registration of adverse reactions
Measured: 8 week, 16 week
Pain according to VAS
Measured: 8 week, 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Investigators
- Johan K Stanghelle, Professor MD, Study chair, Research Departement, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432055
- Sponsor's protocol ID
- 20624503
- Other IDs
- EudraCTnumber: 2006-001427-19
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2007
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00432055
- Acronym / sponsor ID
- 20624503
- Conditions
- Cerebral Palsy
- Keywords
- Adult, Cerebral Palsy, Spastic contractures, Botulinum toxin type A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Feb 2007 (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 purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.
Detailed description
Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia
There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.
Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Botulinum toxin type A (Botox)Botox |
| II | Placebo comparator | Drug: placebo (saline) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral or bilateral spastic CP
- Modified Ashworth Scale (MAS) ≥ 2 in ankle- or knee joint muscles.
- ≥ 18 year of age, ≤ 65 year of age
- Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.
Key exclusion criteria (10 listed)
- Cognitive impairment.
- No spasticity (MAS < 2 )
- < 18 year of age
- Not ambulant without walking aids
- Pregnant or planning pregnancy
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 A (Botox) | Drug | I |
| placebo (saline) | Drug | II |
Primary outcome
Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
Time frame: 8 week
Summary measure of health related quality of life (SF-36)
Time frame: 8 week , 16 week
10 secondary outcomes
Stiffness/spasticity according to VAS
Time frame: 8 week, 16 week
Questionnaire gait function
Time frame: 8 week, 16 week
Spasticity in ankle, knee and hip according to Modified Ashworth Scale
Time frame: 8 week,
3D-gait data (Kinetics,Temporospatial (stride length, velocity)
Time frame: 8 week
Global Scale
Time frame: 8 week, 16 week
Timed Up and Go
Time frame: 8 week
6 minutes walking test
Time frame: 8 week
Registrations of sample characteristics
Time frame: 0 week
Registration of adverse reactions
Time frame: 8 week, 16 week
Pain according to VAS
Time frame: 8 week, 16 week
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 24 Feb 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.
Johan K Stanghelle, Professor MD study chair
Research Departement, Sunnaas Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A (Botox) in people with Cerebral Palsy, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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 10 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 24 Feb 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis) (time frame: 8 week). The study lists 2 primary outcomes in all. 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 24 Feb 2009.