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| Name | Class |
|---|---|
| Prometrika, LLC | INDUSTRY |
| BCS Consulting, Inc. | INDUSTRY |
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The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.
Longitudinal study design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dalfampridine-ER 10mg | Subjects with MS taking dalfampridine-ER 10mg and considered to be responders |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withdrawal of dalfampridine-ER 10mg | Other | 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)
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
| Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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MS Population
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Pardo, MD | OMRF Multiple Sclerosis Center of Excellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OMRF Multiple Sclerosis Center of Excellence | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
| Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
| Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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 | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | Full Analysis Population (FAP) | Posted | Mean | Standard Deviation | units on a scale | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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| Secondary | Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | Full Analysis Population | Posted | Mean | Standard Deviation | units on a scale | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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| Secondary | Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | Full Analysis Population | Posted | Mean | Standard Deviation | Meters | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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| Secondary | Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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 | Full Analysis Population | Posted | Mean | Standard Deviation | Feet per second (ft/s) | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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| Primary | Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg | 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. | Full Analysis Population (FAP) | Posted | Mean | Standard Deviation | units on a scale | 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalfampridine-ER 10mg | 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) | 0 | 20 | 1 | 20 | ||
| EG001 | Dalfampridine-ER Withdrawn | 0 | 20 | 5 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 |
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| Vision blurred | Eye disorders | MedDRA 14.1 |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 |
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| Fatigue | General disorders | MedDRA 14.1 |
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| Gait disturbance | General disorders | MedDRA 14.1 |
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| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
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| Hypertonia | Nervous system disorders | MedDRA 14.1 |
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| Hypokinesia | Nervous system disorders | MedDRA 14.1 |
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| Presyncope | Nervous system disorders | MedDRA 14.1 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Suarez, MD | Acorda Therapeutics, Inc. | (914) 326-5394 | gsuarez@acorda.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
| Superiority or Other |
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