Trial Outcomes & Findings for Otolith Function in Patients With Primary Ciliary Dyskinesia (NCT NCT01246258)
NCT ID: NCT01246258
Last Updated: 2016-04-06
Results Overview
These are the balance tests that specifically assess the otolith organ.
Recruitment status
COMPLETED
Target enrollment
5 participants
Primary outcome timeframe
one day
Results posted on
2016-04-06
Participant Flow
Participant milestones
| Measure |
Test Group
Utricular centrifugation and VEMPs: Standard tests of balance function
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Otolith Function in Patients With Primary Ciliary Dyskinesia
Baseline characteristics by cohort
| Measure |
Test Group
n=5 Participants
Utricular centrifugation and VEMPs: Standard tests of balance function
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one dayThese are the balance tests that specifically assess the otolith organ.
Outcome measures
| Measure |
Test Group
n=5 Participants
VEMPs
|
|---|---|
|
Vestibular Evoked Myogenic Potentials (VEMPs)
Normal VEMP
|
0 participants
|
|
Vestibular Evoked Myogenic Potentials (VEMPs)
Reduced/absent VEMP bilaterally
|
3 participants
|
|
Vestibular Evoked Myogenic Potentials (VEMPs)
Reduced/absent VEMP unilaterally
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one daybalance assessment
Outcome measures
| Measure |
Test Group
n=5 Participants
VEMPs
|
|---|---|
|
Utricular Centrifugation Test (UCF)
Asymmetrical UCF (not significant)
|
3 participants
|
|
Utricular Centrifugation Test (UCF)
Pathological UCF asymmetry
|
0 participants
|
|
Utricular Centrifugation Test (UCF)
Normal UCF
|
2 participants
|
Adverse Events
Test Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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