- Trials with a EudraCT protocol (79)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (42)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: STATISTICAL RESULT OF A DOUBLE-BLIND COMPARATIVE TRIAL WITH LIORESAL VERSUS PLACEBO IN CEREBRAL PALSY IN CHILDREN |
Active substance: BACLOFEN |
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Document reference: 22066 |
Study title: Statistical result of a double-blind comparative trial with Lioresal versus placebo in cerebral palsy in children |
Active substance: BACLOFEN |
Study summary document link (including results): baclofen-LIR 647A NL10 Art45 listing 2011.xls |
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Document reference: 22075 |
Study title: STATISTICAL RESULT OF A DOUBLE-BLIND, BETWEEN-PATIENT COMPARATIVE TRIAL WITH LIORESAL VERSUS PLACEBO IN CEREBRAL PALSY IN CHILDREN |
Active substance: BACLOFEN |
Study summary document link (including results): baclofen-LIR 647A D85 Art45 listing 2011.xls |
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Document reference: 22067 |
Study title: STATISTICAL RESULT OF A DOUBLE-BLIND, BETWEEN-PATIENT COMPARATIVE TRIAL WITH LIORESAL VERSUS PLACEBO IN CEREBRAL PALSY IN CHILDREN |
Active substance: BACLOFEN |
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Document reference: 22072 |
Study title: Statistical result of a double-blind, between-patient comparative trial with Lioresal versus placebo in cerebral palsy in children |
Active substance: BACLOFEN |
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Document reference: 22076 |
Study title: STATISTICAL RESULT OF A DOUBLE-BLIND, WITHIN-PATIENT COMPARATIVE TRIAL WITH LIORESAL VERSUS PLACEBO IN CEREBRAL PALSY IN CHILDREN |
Active substance: BACLOFEN |
Study summary document link (including results): baclofen-LIR 647A DK11 Art45 listing 2011.xls |
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Document reference: 22068 |
Study title: Management of drooling in cerebral palsy: three single case studies. |
Active substance: BENZATROPINE |
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Document reference: 41946 |
Study title: A multicentre, double-blind, prospective, randomised, placebo controlled phase II study to assess the efficacy and safety of botulinum toxin A (Dysport) in the treatment of adductor muscle spasticity in children with cerebral palsy (CP). |
Active substance: Botulinum toxin A |
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Document reference: 22710 |
Study title: A phase IV, Multicentre, Open, prospective study to evaluate the Efficacy & Tolerability of Dysport in the Treatment of Dynamic (non-fixed) Equinus Foot Deformity in young children with Cerebral Palsy |
Active substance: Botulinum toxin A |
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Document reference: 22679 |
Study title: Botulinum Toxin and Short-Term Electrical Stimulation in the Treatment of Equinus in Cerebral Palsy; Detrembleur et al |
Active substance: Botulinum toxin A |
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Document reference: 22687 |
Study title: Central and Peripheral Effects of Botulinum Toxin A in Children with Cerebral Palsy |
Active substance: Botulinum toxin A |
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Document reference: 22692 |
Study title: Parameters for predicting favourable responses to botulinum toxin in children with cerebral palsy; Fattal-Valevski et al |
Active substance: Botulinum toxin A |
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Document reference: 22683 |
Study title: A double-blind, prospective, randomised, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of Dysport with placebo in lower limb spasticity in children with cerebral palsy |
Active substance: Botulinum toxin A; |
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Document reference: 41068 |
Study title: Mathew A, Mathew MC, Thomas M, Antonisamy B. The efficacy of diazepam in enhancing motor function in children with spastic cerebral palsy. J Trop Pediatr. 2005 Apr;51(2):109-13.Mathew A, Mathew MC, Thomas M, Antonisamy B. The efficacy of diazepam in enhancing motor function in children with spastic cerebral palsy. J Trop Pediatr. 2005 Apr;51(2):109-13. |
Active substance: DIAZEPAM |
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Document reference: 25940 |
Study title: Mathew A, Mathew MC. Bedtime diazepam enhances well-being in children with spastic cerebral palsy. Pediatr Rehabil. 2005 Jan-Mar;8(1):63-6. Mathew A, Mathew MC. Bedtime diazepam enhances well-being in children with spastic cerebral palsy. Pediatr Rehabil. 2005 Jan-Mar;8(1):63-6. |
Active substance: DIAZEPAM |
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Document reference: 25941 |
Study title: Botulinum Toxin and Short-Term Electrical Stimulation in the Treatment of Equinus in Cerebral Palsy; Detrembleur et al |
Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A |
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Document reference: 24425 |
Study title: Botulinum Toxin in Cerebral Palsy Upper Extremity Performance: A Placebo Controlled, Double Blind Study |
Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A |
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Document reference: 24431 |
Study title: Injections of Botulinum Toxin A in salivary glands in persons with cerebral palsy and a drooling problem. |
Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A |
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Document reference: 24420 |
Study title: Parameters for predicting favourable responses to botulinum toxin in children with cerebral palsy; Fattal-Valevski et al |
Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A |
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Document reference: 24421 |
Study title: The use of botulinum toxin type A in spastic diplegia due to cerebral palsy; Ward et al |
Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A |
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Document reference: 24426 |