EUCTR2013-003842-18-NL
Active, not recruiting
Phase 1
Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study. - Early Botox in SB patients.
Conditionseurogenic bladder function disease in spina bifida patients.MedDRA version: 16.1Level: LLTClassification code 10030685Term: Open spina bifidaSystem Organ Class: 100000004850MedDRA version: 16.1Level: LLTClassification code 10041531Term: Spina bifida without mention of hydrocephalusSystem Organ Class: 100000004850MedDRA version: 16.1Level: LLTClassification code 10029280Term: Neurogenic bladder, not otherwise specifiedSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eurogenic bladder function disease in spina bifida patients.
- Sponsor
- Erasmus MC
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study group exists of newborns with MMC who are treated with the standard treatment (CIC and anticholinergics). The minimal age at inclusion is 3 months. This is because of the minimal diameter of the urethra which is necessary for cystoscopy.
- •The historical control group exists of MMC patients who have not been treated with Botox and who were born between 1998 and 2008\.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •The exclusion criteria for the study group are:
- •\- Patients with swallowing or breathing problems for which medical treatment is or was necessary.
- •\- Muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis or the Syndrome of Eaton\-Lambert.
- •For the historical group the database of (parents of) patients who object against the use of their medical records for research purposes.
Outcomes
Primary Outcomes
Not specified
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