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Clinical trials for West syndrome

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • 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   44344   clinical trials with a EudraCT protocol, of which   7373   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    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: Short-term nonhormonal and nonsteroid treatment in West syndrome. Short-term nonhormonal and nonsteroid treatment in West syndrome.
    Active substance: NITRAZEPAM
    Study summary document link (including results):
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    Document reference: 32650
    Study title: West syndrome: clinical and electroencephalographic follow up of 70 patients and response to its treatment with adrenocorticotropic hormone, prednisone, vigabatrin, nitrazepam and valproate.
    Active substance: NITRAZEPAM
    Study summary document link (including results):
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    Document reference: 32651
    Study title: Low-dose ACTH therapy for West syndrome: initial effects and long-term outcomeLow-dose ACTH therapy for West syndrome: initial effects and long-term outcome
    Active substance: TETRACOSACTIDE
    Study summary document link (including results):
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    Document reference: 44455
    Study title: A comparative study of high-dose and low-dose ACTH therapy for West syndromeA comparative study of high-dose and low-dose ACTH therapy for West syndrome
    Active substance: TETRACOSACTIDE
    Study summary document link (including results):
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    Document reference: 44474
    Study title: West syndrome: individualized ACTH therapyWest syndrome: individualized ACTH therapy
    Active substance: TETRACOSACTIDE
    Study summary document link (including results):
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    Document reference: 44478
    Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -
    Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)
    Study summary document link (including results):
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    Document reference: 31501
    Study title: Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -
    Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)
    Study summary document link (including results):
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    Document reference: 31516
    Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -
    Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)
    Study summary document link (including results):
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    Document reference: 31520
    Study title: Infantile spasms and West Syndrome Efficacy of short-term ACTH and vigabatrin treatment - Pintaudi M, Baglietto G, Pessagno A, Gaggero R - 2005 (Boll. Lega Ital. Epilepsia 2005; 169-170) Publication in CES 0741 dated 16 Nov 2006 signed A Giudicelli
    Active substance: VIGABATRIN
    Study summary document link (including results):
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    Document reference: 39390
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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