Trial Outcomes & Findings for Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis (NCT NCT01328379)

NCT ID: NCT01328379

Last Updated: 2013-09-05

Results Overview

The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability. A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 430 participants
• Primary outcome timeframe: Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)
• Results posted on: 2013-09-05

Participant Flow

Patients were to be enrolled at a minimum of 60 investigational centers in the United States until a minimum of 405 patients had been randomized.

Participant milestones

Measure	Placebo placebo, twice daily	Dalfampridine-ER 5mg 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Overall Study STARTED	143	144	143
Overall Study COMPLETED	142	144	143
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

Baseline characteristics by cohort

Measure	Placebo n=142 Participants placebo, twice daily	Dalfampridine-ER 5mg n=144 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=143 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily	Total n=429 Participants Total of all reporting groups
Age Continuous	52.2 years STANDARD_DEVIATION 0.83 • n=5 Participants	52.2 years STANDARD_DEVIATION 0.77 • n=7 Participants	53.4 years STANDARD_DEVIATION 0.79 • n=5 Participants	52.6 years STANDARD_DEVIATION 0.46 • n=4 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	102 Participants n=7 Participants	98 Participants n=5 Participants	300 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	129 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	137 Participants n=7 Participants	140 Participants n=5 Participants	409 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)

Population: Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment.

The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.

A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study.

Outcome measures

Measure	Placebo n=136 Participants placebo, twice daily	Dalfampridine-ER 5mg n=143 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=136 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).	0.363 feet per second Standard Error 0.0511	0.423 feet per second Standard Error 0.0470	0.478 feet per second Standard Error 0.0569

SECONDARY outcome

Timeframe: Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)

Population: Full Analysis Population

The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.

A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study.

Outcome measures

Measure	Placebo n=136 Participants placebo, twice daily	Dalfampridine-ER 5mg n=143 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=136 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).	0.301 feet per second Standard Error 0.0496	0.296 feet per second Standard Error 0.0429	0.391 feet per second Standard Error 0.0513

SECONDARY outcome

Timeframe: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

Population: Full Analysis Population

The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.

For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.

MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48

Outcome measures

Measure	Placebo n=136 Participants placebo, twice daily	Dalfampridine-ER 5mg n=143 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=136 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3	-8.35 scores on a scale Standard Error 1.774	-9.73 scores on a scale Standard Error 1.741	-11.10 scores on a scale Standard Error 1.818

SECONDARY outcome

Timeframe: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )

Population: Full Analysis Population

The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.

For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.

MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48

Outcome measures

Measure	Placebo n=136 Participants placebo, twice daily	Dalfampridine-ER 5mg n=142 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=136 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in MSWS-12 at Visit 2	-9.48 scores on a scale Standard Error 1.713	-9.54 scores on a scale Standard Error 1.526	-10.04 scores on a scale Standard Error 1.817

SECONDARY outcome

Timeframe: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )

Population: Full Analysis Population

The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.

Outcome measures

Measure	Placebo n=49 Participants placebo, twice daily	Dalfampridine-ER 5mg n=53 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=51 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in Six-Minute Walk Distance at Visit 2	41.7 Feet Standard Error 23.36	76.8 Feet Standard Error 27.31	128.6 Feet Standard Error 21.66

SECONDARY outcome

Timeframe: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

Population: Full Analysis Population

Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients' health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).

A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3.

Outcome measures

Measure	Placebo n=132 Participants placebo, twice daily	Dalfampridine-ER 5mg n=139 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=126 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.	-0.07 units on a scale Standard Error 0.023	-0.05 units on a scale Standard Error 0.020	-0.07 units on a scale Standard Error 0.024

SECONDARY outcome

Timeframe: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)

Population: Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group.

The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.

Outcome measures

Measure	Placebo n=131 Participants placebo, twice daily	Dalfampridine-ER 5mg n=139 Participants 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=127 Participants 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.	7.0 units on a scale Standard Error 1.43	2.6 units on a scale Standard Error 1.53	4.2 units on a scale Standard Error 1.48

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 77 other events

Deaths: 0 deaths

Dalfampridine-ER 5mg

Serious events: 2 serious events

Other events: 80 other events

Deaths: 0 deaths

Dalfampridine-ER 10mg

Serious events: 2 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=143 participants at risk placebo, twice daily	Dalfampridine-ER 5mg n=144 participants at risk 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=142 participants at risk 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Infections and infestations Breast abscess	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.69% 1/144 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/142 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Infections and infestations Breast cellulitis	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.69% 1/144 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/142 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Nervous system disorders Loss of consciousness	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/144 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.70% 1/142 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/144 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.70% 1/142 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Infections and infestations Urosepsis	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.69% 1/144 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/142 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Ear and labyrinth disorders Vertigo	0.00% 0/143 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.00% 0/144 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.70% 1/142 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo

Other adverse events

Measure	Placebo n=143 participants at risk placebo, twice daily	Dalfampridine-ER 5mg n=144 participants at risk 5mg, twice daily Dalfampridine-ER 5mg: 5mg, twice daily	Dalfampridine-ER 10mg n=142 participants at risk 10mg, twice daily Dalfampridine-ER 10mg: 10mg, twice daily
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 2/143 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	3.5% 5/144 • Number of events 5 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/142 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Musculoskeletal and connective tissue disorders Back pain	2.8% 4/143 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	3.5% 5/144 • Number of events 5 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.2% 6/142 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Nervous system disorders Balance disorder	4.2% 6/143 • Number of events 7 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/144 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	1.4% 2/142 • Number of events 2 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Gastrointestinal disorders Diarrhoea	4.2% 6/143 • Number of events 8 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/144 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/142 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Nervous system disorders Dizziness	2.1% 3/143 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.9% 7/144 • Number of events 7 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	10.6% 15/142 • Number of events 17 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Gastrointestinal disorders Dyspepsia	0.70% 1/143 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.2% 6/144 • Number of events 7 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	0.70% 1/142 • Number of events 1 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Injury, poisoning and procedural complications Fall	4.9% 7/143 • Number of events 9 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	6.9% 10/144 • Number of events 13 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/142 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
General disorders Fatigue	2.1% 3/143 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.8% 4/144 • Number of events 5 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.8% 4/142 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Nervous system disorders Headache	11.2% 16/143 • Number of events 17 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	9.0% 13/144 • Number of events 15 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	12.7% 18/142 • Number of events 18 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Psychiatric disorders Insomnia	4.2% 6/143 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.9% 7/144 • Number of events 7 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	7.7% 11/142 • Number of events 11 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Musculoskeletal and connective tissue disorders Muscle spasms	2.8% 4/143 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.2% 6/144 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/142 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Infections and infestations Nasopharyngitis	2.1% 3/143 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	1.4% 2/144 • Number of events 2 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.2% 6/142 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Gastrointestinal disorders Nausea	3.5% 5/143 • Number of events 5 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	7.6% 11/144 • Number of events 12 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	7.7% 11/142 • Number of events 12 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Musculoskeletal and connective tissue disorders Pain in extremity	2.8% 4/143 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.8% 4/144 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.2% 6/142 • Number of events 6 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Nervous system disorders Paraesthesia	2.8% 4/143 • Number of events 4 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	1.4% 2/144 • Number of events 2 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	4.9% 7/142 • Number of events 12 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Infections and infestations Upper respiratory tract infection	0.70% 1/143 • Number of events 2 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	3.5% 5/144 • Number of events 5 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	2.1% 3/142 • Number of events 3 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo
Infections and infestations Urinary tract infection	5.6% 8/143 • Number of events 9 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	6.2% 9/144 • Number of events 9 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo	9.9% 14/142 • Number of events 14 • On or after start of double-blind treatment through 14 days after the last dose for non-serious events, or up to 30 days after the last dose for serious adverse events (SAEs). Adverse events are treatment-emergent adverse events (TEAEs) that had a date of onset or worsening, on or after start of double-blind treatment. Number of participants exposed to study medication in the Dalfampridine-ER 10mg group (142) is 1 less than total # completed. 1 patient was randomized to Dalfampridine-ER 10mg but actually received placebo

Additional Information

Vice President - Clinical Development & Medical Affairs

Acorda Therapeutics

Phone: (914) 347- 4300

Email: hhenney@acorda.com

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