Trial Outcomes & Findings for A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke (NCT NCT01605825)

NCT ID: NCT01605825

Last Updated: 2016-01-22

Results Overview

A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 83 participants
• Primary outcome timeframe: up to 36 days
• Results posted on: 2016-01-22

Participant Flow

Participant milestones

Measure	Placebo/Dalfampridine-ER Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Dalfampridine-ER/Placebo Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Overall Study STARTED	55	28
Overall Study COMPLETED	45	25
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Measure	Placebo/Dalfampridine-ER Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Dalfampridine-ER/Placebo Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Overall Study Adverse Event	4	2
Overall Study Withdrawal by Subject	0	1
Overall Study Non-Compliance -Investigational Drug	3	0
Overall Study Non-Compliance with Protocol	3	0

Baseline Characteristics

A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Baseline characteristics by cohort

Measure	Placebo/Dalfampridine-ER n=55 Participants Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Dalfampridine-ER/Placebo n=28 Participants Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Total n=83 Participants Total of all reporting groups
Sex: Female, Male Male	37 Participants n=5 Participants	18 Participants n=7 Participants	55 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 9.72 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.91 • n=7 Participants	59.5 years STANDARD_DEVIATION 9.82 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	22 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 36 days

Population: Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.

A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.

The severity categories of mild, moderate or severe, are defined below:

• Mild is defined as causing no limitation of usual activities
• Moderate is defined as causing some limitation of usual activities
• Severe is defined as causing inability to carry out usual activities

Outcome measures

Measure	Placebo n=81 Participants	Dalfampridine-ER n=77 Participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) Subjects who died	0 participants	0 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) Subjects with any TEAEs	30 participants	42 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs Possibly Related to study drug	16 participants	24 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs Maximum Severity - Mild	16 participants	29 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs Maximum Severity - Moderate	13 participants	10 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs Maximum Severity - Severe	1 participants	3 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs leading to withdrawal of study drug	1 participants	5 participants
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) TEAEs Serious	2 participants	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening visit, Days 1, 8, 15, 22, 29 and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening visit, Days 1, 8, 15, 22, 29, and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 8, 15, 22, 29, and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 8, 15, 22, 29, and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 8, 15, 22, 29 and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 8, 15, 22, 29 and 36

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 8, 15, 22, 29, and 36

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Dalfampridine-ER

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=81 participants at risk	Dalfampridine-ER n=77 participants at risk
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Nausea	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Vomiting	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Metabolism and nutrition disorders Dehydration	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Convulsion	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Psychiatric disorders Suicide attempt	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment

Other adverse events

Measure	Placebo n=81 participants at risk	Dalfampridine-ER n=77 participants at risk
General disorders Gait disturbance	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Injury, poisoning and procedural complications Laceration	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
General disorders Pain	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Paraesthesia	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Injury, poisoning and procedural complications Fall	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Frequent bowel movements	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Dizziness	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	10.4% 8/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Nausea	6.2% 5/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	3.9% 3/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
General disorders Fatigue	3.7% 3/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	5.2% 4/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Psychiatric disorders Insomnia	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	5.2% 4/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 3/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
General disorders Asthenia	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	3.9% 3/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Constipation	4.9% 4/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Headache	3.7% 3/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Convulsion	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Diarrhoea	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Drooling	3.7% 3/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Dry mouth	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Abdominal discomfort	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Abdominal pain upper	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
General disorders Chest pain	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Metabolism and nutrition disorders Decreased appetite	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Psychiatric disorders Depression	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Skin and subcutaneous tissue disorders Rash	1.2% 1/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	1.3% 1/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Nervous system disorders Tremor	0.00% 0/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	2.6% 2/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment
Gastrointestinal disorders Vomiting	2.5% 2/81 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment	0.00% 0/77 • up to 36 days All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment

Additional Information

Study Director

Acorda Therapeutics, Inc.

Phone: 914-347-4300

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor (Acorda) has the 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