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NCT02829827

A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)

Terminated Phase 2 Last updated 17 September 2019
What this trial tests

Phase 2 trial testing Radiprodil in Infantile Spasms (IS) in 3 participants. Terminated before completion.

Timeline
4 December 2017
Primary endpoint
2 October 2018
2 October 2018

Quick facts

Lead sponsorUCB Biopharma S.P.R.L.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date4 December 2017
Primary completion2 October 2018
Estimated completion2 October 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

UCB Biopharma S.P.R.L. — full company profile →

Who can join

Adults 2 Months to 14 Months, any sex, with Infantile Spasms (IS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Allosteric Modulation of Ionotropic Glutamate Receptors: An Outlook on New Therapeutic Approaches To Treat Central Nervous System Disorders.
    Brogi S, Campiani G, Brindisi M, Butini S. · · 2019 · cited 31× · PMID 30891118 · DOI 10.1021/acsmedchemlett.8b00450
  2. Radiprodil, a NR2B negative allosteric modulator, from bench to bedside in infantile spasm syndrome.
    Auvin S, Dozières-Puyravel B, Avbersek A, Sciberras D, et al · · 2020 · cited 26× · PMID 32106360 · DOI 10.1002/acn3.50998
  3. A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques.
    Sciberras D, Otoul C, Lurquin F, Smeraglia J, et al · · 2019 · cited 18× · PMID 30705758 · DOI 10.1002/prp2.459

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Other UCB Biopharma S.P.R.L. trials

Trials by the same sponsor.

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Data sources for this page

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