Status:
COMPLETED
Evaluation of PDE MAX
Lead Sponsor:
Vitaflo International, Ltd
Collaborating Sponsors:
Radboud University Medical Center
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Pyridoxine Dependant Epilepsy
Eligibility:
All Genders
1+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Diagnosis of Pyridoxine Dependent Epilepsy (PDE), biochemically and/or genetically confirmed.
- Males or females aged one (1) year and above. Any participant aged 16 years and over at screening must have the capacity to consent for themselves.
- Currently following a lysine-restricted diet for a minimum of four (4) weeks prior to screening.
- Willing to take the study product and follow advice given by the dietitian.
- Willingly given, written, informed consent from patient or parent/guardian.
- Willingly given, written assent (if appropriate).
Exclusion
- Inability to comply with the study protocol, in the opinion of the investigator.
- Use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator, such as but not limited to arginine and pyridoxine. In which case, supplementation must have started four (4) weeks prior to screening with no anticipated changes to intakes during the study duration.
- Participants who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period. Participants of child-bearing potential will be required to undergo pregnancy test prior to enrolment.
- N.B.: Participants who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.
- Allergy to any ingredient present in the study product.
- Other concurrent medical or psychiatric conditions, which, in the opinion of the Investigator, would place the subject at increased risk, preclude obtaining voluntary consent/assent or compliance with required study procedures, or would confound the objectives of the study.
- Is participating in any other interventional study and has received any other investigational drug, product or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the investigator, would interfere with study compliance or outcome assessments.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04672226
Start Date
June 1 2021
End Date
July 31 2023
Last Update
February 16 2024
Active Locations (2)
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1
Radboud UMC
Nijmegen, Netherlands, 6500
2
Great Ormond Street Hospital for Children
London, United Kingdom