Trial Outcomes & Findings for A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease (NCT NCT01491022)
NCT ID: NCT01491022
Last Updated: 2018-01-02
Results Overview
The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Ampyra Then Placebo
Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
|
Placebo Then Ampyra
placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
|
|---|---|---|
|
Intervention 1
STARTED
|
10
|
12
|
|
Intervention 1
COMPLETED
|
9
|
11
|
|
Intervention 1
NOT COMPLETED
|
1
|
1
|
|
2 Week Washout
STARTED
|
9
|
11
|
|
2 Week Washout
COMPLETED
|
9
|
11
|
|
2 Week Washout
NOT COMPLETED
|
0
|
0
|
|
Intervention 2
STARTED
|
9
|
11
|
|
Intervention 2
COMPLETED
|
8
|
11
|
|
Intervention 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Ampyra Then Placebo
n=10 Participants
Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
|
Placebo Then Ampyra
n=12 Participants
Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
67.4 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
67.5 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksThe primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
Change in Velocity
|
0.03 m/s
Standard Deviation 0.03
|
0.05 m/s
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: 4 weekschange in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
United Parkinson's Disease Rating Scale Score(UPDRS) ,
|
35.22 units on a scale
Standard Error 14.4
|
35.55 units on a scale
Standard Error 13.7
|
SECONDARY outcome
Timeframe: 4 weekschange in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
Freezing of Gait Questionnaire (FOGQ)
|
13.16 units on a scale
Standard Deviation 4.9
|
13.4 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 4 weekstime required to perform TUG.
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
Timed Up and Go (TUG) Score
|
23.25 seconds
Standard Error 15.4
|
20.6 seconds
Standard Error 15.3
|
SECONDARY outcome
Timeframe: 4 weekstime required to perform T25FW.
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
Timed 25-foot Walk Test (T25FW)
|
11.6 seconds
Standard Error 5.0
|
11.8 seconds
Standard Error 6.5
|
SECONDARY outcome
Timeframe: 4 weekschange in stride length as measured by 3 D capture analysis
Outcome measures
| Measure |
Ampyra
n=20 Participants
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=20 Participants
placebo: placebo
|
|---|---|---|
|
Change in Stride Legth
|
-0.01 meters
Standard Deviation 0.04
|
0.05 meters
Standard Deviation 0.04
|
Adverse Events
Ampyra
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ampyra
n=22 participants at risk
Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks
|
Placebo
n=22 participants at risk
placebo: placebo
|
|---|---|---|
|
Nervous system disorders
dizzines
|
18.2%
4/22 • Number of events 4 • at 10 weeks
|
4.5%
1/22 • Number of events 1 • at 10 weeks
|
|
Infections and infestations
urinary tract infection
|
9.1%
2/22 • Number of events 2 • at 10 weeks
|
4.5%
1/22 • Number of events 1 • at 10 weeks
|
|
Nervous system disorders
balance worsening
|
9.1%
2/22 • Number of events 2 • at 10 weeks
|
0.00%
0/22 • at 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place