Clinical Trials Directory

Trials / Completed

CompletedNCT04672226

Evaluation of PDE MAX

A Feasibility Study to Evaluate PDE MAX, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Pyridoxine Dependent Epilepsy (PDE) With Regards to Acceptability, Tolerability, Adherence and Effect on Metabolic Control

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Vitaflo International, Ltd · Industry
Sex
All
Age
1 Year
Healthy volunteers
Not accepted

Summary

PDE MAX is a single arm prospective, feasibility study in up to 15 participants aged one (1) year and over of PDE MAX for the dietary management of Pyridoxine Dependent Epilepsy.

Detailed description

PDE Max is a newly-developed product designed specifically to meet the nutritional requirements of patients following a lysine-restricted diet for PDE. This is a feasibility study to evaluate PDE MAX, a food for special medical purposes (FSMP) for use in the dietary management of Pyridoxine Dependent Epilepsy (PDE) with regards to acceptability, tolerability, adherence and effect on metabolic control. Participants will be given an eight-week supply of PDE MAX and they will be asked to complete a daily diary and short questionnaire to record information on: adherence, gastrointestinal tolerance, palatability and how the product is used. Blood and urine samples will be taken at the beginning and end of the study to measure several biochemical parameters. Physical and neurological assessments will be carried out by the local Metabolic Consultant at the beginning and end of the study. Routine monitoring of lysine levels will continue.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPDE MAXPDE MAX will be prescribed by the study dietitian based on the patient's individual requirement.

Timeline

Start date
2021-06-01
Primary completion
2023-07-20
Completion
2023-07-31
First posted
2020-12-17
Last updated
2024-02-16

Locations

2 sites across 2 countries: Netherlands, United Kingdom

Source: ClinicalTrials.gov record NCT04672226. Inclusion in this directory is not an endorsement.