interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44381
clinical trials with a EudraCT protocol, of which
7393
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Doubleblind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of ...
Medical condition: Tuberous Sclerosis Complex
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10010331 - Congenital, familial and genetic disorders
10080584
Tuberous sclerosis complex
PT
Population Age: Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:IT(Trial now transitioned)ES(Ongoing)PL(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2021-002480-22
Sponsor Protocol Number: TAK-935-3001
Start Date*: 2021-07-22
Sponsor Name:Takeda Development Center Americas, Inc
Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adul...
Medical condition: Dravet Syndrome (DS)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004850
10073682
Dravet syndrome
LLT
Population Age: Children, Adolescents, Under 18, Adults
Sponsor Name:Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc
Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
Medical condition: Seizures associated with Dravet syndrome
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004850
10073682
Dravet syndrome
LLT
Population Age: Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)BE(Completed)DE(Completed)IT(Completed)DK(Completed)ES(Ongoing)FR(Completed)
Sponsor Name:Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom
Full Title: A RANDOMIZED, COMPARATIVE, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTER, MONOTHERAPY, STUDY OF PREGABALIN (LYRICA) AND LAMOTRIGINE (LAMICTAL) IN PATIENTS WITH NEWLY DIAGNOSED PARTIAL SEIZURES
Medical condition: Epilepsy; Patients with newly diagnosed partial seizures (with or without secondary generalization)
Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Medical condition: Dravet syndrome
Disease:
Version
SOC Term
Classification Code
Term
Level
17.0
10010331 - Congenital, familial and genetic disorders
Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
Medical condition: Tuberous Sclerosis Complex (TSC)-related epilepsy
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004852
10032062
Other forms of epilepsy, with intractable epilepsy
LLT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly
Sponsor Name:GlaxoSmithKline Research and Development Ltd
Full Title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Medical condition: Epilepsy - Primary genralised tonic clonic seizures
Disease:
Population Age: Adolescents, Under 18, Adults, Elderly
Full Title: A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GE...
Medical condition: Epilepsy
Disease:
Version
SOC Term
Classification Code
Term
Level
18.0
10029205 - Nervous system disorders
10015037
Epilepsy
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18
Full Title: A randomized, multi-centre, double-blind study, to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy, in newly diagnosed partial epilepsy
Full Title: An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Se...
Medical condition: Treatment of stereotypical prolonged seizure
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029205 - Nervous system disorders
10076333
Prolonged seizure
LLT
Population Age: Adolescents, Under 18, Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)ES(Ongoing)IT(Trial now transitioned)FR(Not Authorised)HU(Trial now transitioned)CZ(Trial now transitioned)PL(Trial now transitioned)BG(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2015-001223-23
Sponsor Protocol Number: CAPSS-311
Start Date*: 2015-04-24
Sponsor Name:Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Full Title: TOPAMAX (Topiramate) Initiated as Monotherapy in Epilepsy (TIME): A Multicenter, Outpatient, Open-Label, Study to Evaluate the Dosing, Effectiveness and Safety of TOPAMAX as Monotherapy in the Trea...
Medical condition: New onset epilepsy
Disease:
Population Age: Children, Adolescents, Under 18, Adults, Elderly
Sponsor Name:Takeda Development Center, Americas (TDC Americas)
Full Title: A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients with Status Epilepticus (Convulsive) in Community Settings
Medical condition: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years)
Full Title: Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Postoperative Hemoglobin Loss. A Phase 2 Randomized Double-blind Monocentric Study
Full Title: An open-label, multicenter, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV) (oral tablets of 166, 250 or 500 mg b.i.d.), at individualized doses up to a maximum of 4000 m...
Medical condition: Neurology, epilepsy, primary generalized seizures
Disease:
Version
SOC Term
Classification Code
Term
Level
10018079
LLT
Population Age: Children, Adolescents, Under 18, Adults
Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EXAMINE THE EFFICACY AND SAFETY OF ZX008 IN SUBJECTS WITH CDKL5 DEFICIENCY DISORDER FOLLOWED BY AN OPEN-LABE...
Medical condition: CDKL5 DEFICIENCY DISORDER
Disease:
Version
SOC Term
Classification Code
Term
Level
22.1
10010331 - Congenital, familial and genetic disorders
10083005
CDKL5 deficiency disorder
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:PT(Trial now transitioned)DE(Trial now transitioned)FR(Not Authorised)NL(Trial now transitioned)AT(Trial now transitioned)BE(Trial now transitioned)IE(Trial now transitioned)IT(Trial now transitioned)ES(Ongoing)
Trial results:(No results available)
EudraCT Number: 2007-003161-40
Sponsor Protocol Number: A0081143
Start Date*: 2007-12-14
Sponsor Name:Pfizer Inc,East 42nd street,New york, NY10017, USA
Full Title: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, MULTI-CENTER, COMPARATIVE, FLEXIBLE DOSE TRIAL OF PREGABALIN VERSUS GABAPENTIN AS ADJUNCTIVE THERAPY IN SUBJECTS WITH PARTIAL SEIZURES
Medical condition: Adjunctive treatment for subjects with partial seizures, with or without secondary generalization.
Full Title: A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young ...
Medical condition: Dravet Syndrome
Disease:
Version
SOC Term
Classification Code
Term
Level
18.0
10010331 - Congenital, familial and genetic disorders
10073677
Severe myoclonic epilepsy of infancy
PT
Population Age: Children, Adolescents, Under 18, Adults
Full Title: A Phase 3, Multicenter, Open-label Study to Determine the Efficacy, Safety, and Pharmacokinetics of Buccally Administered MHOS/SHP615 in Pediatric Patients with Status Epilepticus (Convulsive) in t...
Medical condition: Acute Convulsive Seizures
Disease:
Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18
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