A prospective randomised double blind study of dosage efficacy of Botox® Vs Dysport® in children with spastic diplegic cerebral palsy (CP)
| ISRCTN | ISRCTN34438724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34438724 |
| Protocol serial number | N0123134254 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Andrew Furlong
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| andrew.furlong@uhl-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective randomised double blind study of dosage efficacy of Botox® Vs Dysport® in children with spastic diplegic cerebral palsy (CP) |
| Study objectives | To determine the efficacy ratio of Botox® and Dysport® in spastic cerebral palsy for comparable outcomes. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Randomised controlled trial to determine the dosage efficacy of Botox versus Dysport in spastic cerebral palsy. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin type A (Botox®, Dysport®) |
| Primary outcome measure(s) |
Functional improvement at 12 months, need for further injections |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 06/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Key inclusion criteria | Spastic diplegic symmetrical CP children with >2 + equinus deformity or tight hamstrings |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 17/12/2003 |
| Date of final enrolment | 06/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/05/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.
