PKUNCT04309331
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute
A study testing Motion in people with PKU and Phenylketonurias, run by Dr. Schär AG / SPA at 1 site in United Kingdom.
Trial summary
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- PKU, Phenylketonurias, Inborn Errors of Metabolism
- What is being tested?
- Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 19 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
- Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
- Patients aged 3 years of age to adulthood
- Written informed consent obtained from parental caregiver
Who cannot join
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Patients less than 3 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
- Conditions
- PKU, Phenylketonurias, Inborn Errors of Metabolism, Metabolic Disease
- Being tested
- Motion
- Medical subject headings
- Phenylketonurias, Metabolism, Inborn Errors, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotionDietary supplement
Amino acid based protein substitute
| Study group | Role | What they receive |
|---|---|---|
| PKU Motion | Experimental | amino acid based protein substitute Receives: Dietary Supplement: Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Questionnaire detailing any GI symptoms, severity and change from usual
- The collection of daily data about the gastro-intestinal tolerance of the protein substitute.
Measured: 7 days
Product compliance
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Measured: 7 days
Product palatability
Questionnaire data captured to evaluate taste
Measured: 7 days
Product acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jul 2018
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PKUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Schär AG / SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309331
- Sponsor's protocol ID
- Motion1
- Status last verified
- Mar 2020
- First submitted
- 13 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits
- ClinicalTrials.gov ID
- NCT04309331
- Acronym / sponsor ID
- Motion1
- Conditions
- PKU, Phenylketonurias, Inborn Errors of Metabolism, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dr. Schär AG / SPAIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PKU Motion | Experimental | Dietary Supplement: Motionamino acid based protein substitute |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
- Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
- Patients aged 3 years of age to adulthood
- Written informed consent obtained from parental caregiver
Key exclusion criteria (5 listed)
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Patients less than 3 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotionAmino acid based protein substitute | Dietary supplement | PKU Motion |
Primary outcome
Gastrointestinal tolerance
Time frame: 7 days
Questionnaire detailing any GI symptoms, severity and change from usual • The collection of daily data about the gastro-intestinal tolerance of the protein substitute.
Product compliance
Time frame: 7 days
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability
Time frame: 7 days
Questionnaire data captured to evaluate taste
Product acceptability
Time frame: 7 days
Brief tick-box questionnaire on overall liking and acceptability of product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion in people with PKU and Phenylketonurias, run by Dr. Schär AG / SPA at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.