Trial Outcomes & Findings for A Pilot Study on Diurnal Variation (NCT NCT01806051)
NCT ID: NCT01806051
Last Updated: 2016-04-20
Results Overview
To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.
TERMINATED
NA
6 participants
Baseline and 4 weeks
2016-04-20
Participant Flow
No data was collected because all of the participants who consented to participate in the study withdrew due to the procedural challenges of remaining in the study (e.g. the PM blood draws were too disruptive).
Participant milestones
| Measure |
All Participants
Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
All Participants
Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
A Pilot Study on Diurnal Variation
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Participants withdrew before any data were collected.
To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.
Outcome measures
Outcome data not reported
Adverse Events
PKU Participants (Arm 1)
Control Group (Arm 2)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place