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Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy (SoluWest)

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ClinicalTrials.gov Identifier: NCT02220114
Recruitment Status : Unknown
Verified August 2015 by Targeon SAS.
Recruitment status was:  Recruiting
First Posted : August 19, 2014
Last Update Posted : August 26, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.

This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:

  • evaluation of the palatability and user-friendliness of the new treatment,
  • evaluation of the pharmacokinetic parameters of the new formulation,
  • PK parameters,
  • evaluation of the tolerance,
  • measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.

Condition or disease Intervention/treatment
Infantile Spasms Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril®

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016


Arms and Interventions

Arm Intervention/treatment
Vigabatrin: Vigabatrin new ST formulation then Sabril®

Sabril®: sachet for oral solution 500 mg, 50 to 100mg/Kg/day, twice a day, 14 days.

Vigabatrin new ST formulation: Soluble tablets 100 or 500 mg, 50 to 100mg/Kg/day, twice a day, 12 weeks.

Drug: Vigabatrin: Vigabatrin new ST formulation then Sabril®
  • first "treatment" phase (V1/D1-V3/D84), in which patients already under Sabril® "granules for oral solution" and naive patients start the new ST formulation; patients already under Sabril® will start at the same dose and regimen as their usual Sabril®. Dose and regimen for naive patients will be chosen according to SPC.
  • second "treatment" phase (V3/D84-V4/D98) in which the patient is switched to Sabril® "granules for oral solution" (supplied by sponsor) for 15 days at the same dose as under the new ST formulation.

Dose and treatment regimen should be maintained as in first treatment phase.

- At V4/D98, patients who received Sabril® "granules for oral solution" (supplied by sponsor) continue with marketed Sabril® treatment (or switches to another AED, according to the natural evolution of the patient's condition and upon investigator decision).



Outcome Measures

Primary Outcome Measures :
  1. Individual adherence to the new Soluble Tablets (ST) formulation of Vigabatrin (VGB) using Medication Event Monitoring System (MEMS) [ Time Frame: from V1 (day 1) to V3 (day 84), continuous assessment. ]
    Adherence will be assessed by measurement of the dosing history of patients using an electronic Medication Event Monitoring System (MEMS).The date and time of each opening will be recorded


Secondary Outcome Measures :
  1. Adherence to the new ST formulation and to Sabril® granules for oral solution, by treatment unit accountability [ Time Frame: VGB-ST: V1 (day 1) to V3 (day 84). Sabril®:V3 (day 85) to V4 (day 98) ]
    Accountability of used and unused treatment units, retrieved by the patient at V3 and V4

  2. palatability of the new ST formulation and of Sabril® "granules for oral solution". [ Time Frame: during 7 consecutive days: from D90 to D96 under Sabril® and from D29 to D35 under the new ST formulation ]
    Palatability of the treatment will be evaluated using a two face visual hedonic scale filled in by the parents and/or by the child, if feasible, on a daily basis. Each "face" of the scale will be assigned a score (1 to 2), and the average score will be calculated for the group. Palatability will be considered good if the average score for the group is at least 1.5 (out of a maximum of 2; Motte et al. 2005).

  3. Ease of use of the new ST formulation and of Sabril® "granules for oral solution". [ Time Frame: during 7 consecutive days: from D90 to D96 under Sabril® and from D29 to D35 under the new ST formulation. ]
    Ease of use will be evaluated using diaries filled by the parents or care-givers during 7 consecutive days: . Time required for preparation of both new ST formulation and Sabril® administrations will be averaged and compared, together with the global use satisfaction.

  4. Safety and tolerance [ Time Frame: Results of electroretinogram: when available from D1 to D126; Blood assessment: at D1 & D84; Vital signs at D1, D28, D84, D98 & D126; Adverse events, serious adverse events: evaluated for the duration of study participation (at D1, D28, D84, D98 & D126) ]
    VGB safety profile is well known. The new ST formulation is expected to be bioequivalent to Sabril®, and since the new formulation does not contain excipients known to have a recognized action or effect at the dose used, the safety of the new formulation should be similar to that of Sabril®. Hence no other measures specific to the new ST formulation are included in the clinical acceptability study.

  5. pharmacokinetic parameters for the new ST formulation (1 sample). Pharmacokinetic parameters for the new ST formulation (population PK) : Area under the curve (AUC), Tmax, Cmax, T½, Ka, V/F, Cl/F [ Time Frame: PK D84: 1 sample before treatment. ]
    The objective is to better characterize the developmental PK of vigabatrin during childhood.

  6. Evaluation of the taurine plasma levels in children treated by vigabatrin. Taurine plasma concentration will be measured and a relationship between vigabatrin exposition and taurine plasma levels will be sought. [ Time Frame: 1 sample will be drawn at V3 (day 84): just before treatment when patient is fasting. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset seizures (POS).
  • Infants > 1 month and < 6 months; infants > 6 months and < 2 years; and children > 2 years and < 6 years.
  • Patients under Sabril® or naive patients.
  • Patients under a twice-a-day posology of Sabril® or patients for whom vigabatrin will be given twice daily.

Non inclusion Criteria:

  • Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs.
  • Subjects receiving vigabatrin through a gastric tube.
  • Weight < 1.750 Kgs.
  • Any planned major surgery within the duration of the trial.
  • Participation in any other clinical trial within 3 months prior to V1.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220114


Contacts
Contact: Hugues BIENAYME +33142770818 h.bienayme@targeon-pharma.com
Contact: Segolene GAILLARD +33427857728 segolene.gaillard@chu-lyon.fr

Locations
France
Service de neurologie pédiatrique - CHU Recruiting
Amiens, France, 80054
Principal Investigator: Patrick BERQUIN         
Service de neurologie pédiatrique - CHU Recruiting
Angers, France, 49033²
Principal Investigator: Sylvie N'GUYEN         
Service de neuropédiatrie - CHU Pellegrin Enfants Completed
Bordeaux, France, 33076
Service de neurologie infantile - Hôpital Salengro Not yet recruiting
Lille, France, 59037
Principal Investigator: Louis VALLEE         
Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant Recruiting
Lyon, France, 69677
Principal Investigator: Dorothée VILLE         
Service de neurologie pédiatrique - Hôpital de la Timone Recruiting
Marseille, France, 13385
Principal Investigator: Nathalie VILLENEUVE         
Service de neurologie pédiatrique - Hôpital Necker Enfants Malades Active, not recruiting
Paris, France, 75015
Service de neuropédiatrie - Hôpital Robert Debré Not yet recruiting
Paris, France, 75019
Principal Investigator: Stephane AUVIN         
Service de neurologie pédiatrique - Hôpital Sud Recruiting
Rennes, France, 35203
Principal Investigator: Sylvia NAPURI         
Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Principal Investigator: Anne DE SAINT MARTIN         
Service de neuropédiatrie - Hôpital Purpan Recruiting
Toulouse, France, 331059
Principal Investigator: Claude CANCES         
Service de neuropédiatrie - Hôpital de Clocheville Recruiting
Tours, France, 37044
Principal Investigator: Marie-Anne BARTHEZ         
Sponsors and Collaborators
Targeon SAS
Institut National de la Santé Et de la Recherche Médicale, France
Hospices Civils de Lyon
National Research Agency, France
Investigators
Principal Investigator: Rima NABBOUT Hôpital Necker Enfants Malades - APHP
More Information

Responsible Party: Targeon SAS
ClinicalTrials.gov Identifier: NCT02220114     History of Changes
Other Study ID Numbers: TGO-VGB-III-01
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Targeon SAS:
Infantile spasms
vigabatrin
soluble tablets
acceptability
adherence
pharmacokinetics

Additional relevant MeSH terms:
Epilepsy
Spasm
Muscle Cramp
Epilepsies, Partial
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Epilepsy, Generalized
Vigabatrin
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs