Trial Outcomes & Findings for An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS) (NCT NCT01535664)
NCT ID: NCT01535664
Last Updated: 2013-10-14
Results Overview
The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway). Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Results posted on
2013-10-14
Participant Flow
Participant milestones
| Measure |
Dalfampridine-ER 10mg
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Dalfampridine-ER 10mg
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
|---|---|
|
Age Continuous
|
53.1 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)Population: Full Analysis Population (FAP)
The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway). Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Outcome measures
| Measure |
Dalfampridine-ER Withdrawn
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER 10 mg
n=20 Participants
|
|---|---|---|
|
Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
|
46.01 units on a scale
Standard Deviation 23.716
|
51.40 units on a scale
Standard Deviation 21.582
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PRIMARY outcome
Timeframe: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)Population: Full Analysis Population (FAP)
The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT\*0.5) + (ZADT\*0.2) + (ZLOS\*0.3) Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Outcome measures
| Measure |
Dalfampridine-ER Withdrawn
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER 10 mg
n=20 Participants
|
|---|---|---|
|
Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
|
55.10 units on a scale
Standard Deviation 27.150
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54.98 units on a scale
Standard Deviation 24.160
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SECONDARY outcome
Timeframe: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)Population: Full Analysis Population
The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.
Outcome measures
| Measure |
Dalfampridine-ER Withdrawn
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER 10 mg
n=20 Participants
|
|---|---|---|
|
Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
|
45.7 units on a scale
Standard Deviation 7.26
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47.3 units on a scale
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)Population: Full Analysis Population
Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch. A larger walking distance is indicative of better performance.
Outcome measures
| Measure |
Dalfampridine-ER Withdrawn
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER 10 mg
n=20 Participants
|
|---|---|---|
|
Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
|
119.381 Meters
Standard Deviation 35.9033
|
129.044 Meters
Standard Deviation 28.8752
|
SECONDARY outcome
Timeframe: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)Population: Full Analysis Population
The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population A higher walking speed is indicative of better performance
Outcome measures
| Measure |
Dalfampridine-ER Withdrawn
n=20 Participants
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER 10 mg
n=20 Participants
|
|---|---|---|
|
Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
|
3.42 Feet per second (ft/s)
Standard Deviation 1.062
|
3.78 Feet per second (ft/s)
Standard Deviation 0.901
|
Adverse Events
Dalfampridine-ER 10mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dalfampridine-ER Withdrawn
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dalfampridine-ER 10mg
n=20 participants at risk
Subjects with MS taking dalfampridine-ER 10mg
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
|
Dalfampridine-ER Withdrawn
n=20 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
General disorders
Gait disturbance
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
5.0%
1/20 • Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).
All summaries of AEs were based on treatment-emergent AEs (TEAE). TEAE was defined as an AE with date of onset (or worsening) that occurred on or after the Screening Visit (Visit 1) through 30 days after the last dose of investigational product taken in Period 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
- Publication restrictions are in place
Restriction type: OTHER