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This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo/dalfampridine-ER | Placebo Comparator | 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/placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo/dalfampridine-ER | Drug | Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | 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:
| up to 36 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) | Screening visit, Days 1, 8, 15, 22, 29 and 36 | |
| Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA) | Screening visit, Days 1, 8, 15, 22, 29, and 36 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathews Adera, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Site #011 | Birmingham | Alabama | 35294 | United States | ||
| Acorda Site #018 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23652269 | Derived | Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| dalfampridine-ER/placebo | Drug | Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart |
|
| Manual Dexterity as Measured by the Box and Block Test | Days 1, 8, 15, 22, 29, and 36 |
| Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale | Days 1, 8, 15, 22, 29, and 36 |
| Subject Global Impression (SGI) Scale | Days 8, 15, 22, 29 and 36 |
| Clinician Global Impression (CGI) Scale | Days 8, 15, 22, 29 and 36 |
| Hand Strength as Measured by the Grip Test and Pinch Tests | Days 1, 8, 15, 22, 29, and 36 |
| La Jolla |
| California |
| 92103 |
| United States |
| Acorda Site #016 | Newport Beach | California | 92663 | United States |
| Acorda Site #006 | Fairfield | Connecticut | 06824 | United States |
| Acorda Site #002 | Atlantis | Florida | 33462 | United States |
| Acorda Site #015 | Fort Lauderdale | Florida | 33308 | United States |
| Acorda Site #003 | Decatur | Georgia | 30033 | United States |
| Acorda Site #021 | Lexington | Kentucky | 40513 | United States |
| Acorda Site #009 | Boston | Massachusetts | 02118 | United States |
| Acorda Site #017 | Saginaw | Michigan | 48604 | United States |
| Acorda Site #020 | Great Falls | Montana | 59405 | United States |
| Acorda Site #023 | Reno | Nevada | 89502 | United States |
| Acorda Site #022 | New Brunswick | New Jersey | 08901 | United States |
| Acorda Site #019 | Buffalo | New York | 14220 | United States |
| Acorda Site #007 | West Haverstraw | New York | 10993 | United States |
| Acorda Site #004 | White Plains | New York | 10605 | United States |
| Acorda Site #013 | Charlotte | North Carolina | 28207 | United States |
| Acorda Site #001 | Philadelphia | Pennsylvania | 19104 | United States |
| Acorda Site #008 | Norfolk | Virginia | 23507 | United States |
| Acorda Site #010 | Bellevue | Washington | 98004 | United States |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: The Safety Population consists of all randomized subjects who took at least one dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | 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:
| 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. | Posted | Number | participants | up to 36 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) | Not Posted | Screening visit, Days 1, 8, 15, 22, 29 and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA) | Not Posted | Screening visit, Days 1, 8, 15, 22, 29, and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Manual Dexterity as Measured by the Box and Block Test | Not Posted | Days 1, 8, 15, 22, 29, and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale | Not Posted | Days 1, 8, 15, 22, 29, and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject Global Impression (SGI) Scale | Not Posted | Days 8, 15, 22, 29 and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Clinician Global Impression (CGI) Scale | Not Posted | Days 8, 15, 22, 29 and 36 | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hand Strength as Measured by the Grip Test and Pinch Tests | Not Posted | Days 1, 8, 15, 22, 29, and 36 |
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
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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 | Placebo | 2 | 81 | 30 | 81 | |||
| EG001 | Dalfampridine-ER | 2 | 77 | 42 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (15.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (15.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) |
| ||
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (15.0) |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) |
| ||
| Convulsion | Nervous system disorders | MedDRA (15.0) |
| ||
| Suicide attempt | Psychiatric disorders | MedDRA (15.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (15.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (15.0) |
| ||
| Fatigue | General disorders | MedDRA (15.0) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (15.0) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
| ||
| Asthenia | General disorders | MedDRA (15.0) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA (15.0) |
| ||
| Headache | Nervous system disorders | MedDRA (15.0) |
| ||
| Convulsion | Nervous system disorders | MedDRA (15.0) |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) |
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| Drooling | Nervous system disorders | MedDRA (15.0) |
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| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
| ||
| Chest pain | General disorders | MedDRA (15.0) |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) |
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| Depression | Psychiatric disorders | MedDRA (15.0) |
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| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA (15.0) |
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| Gait disturbance | General disorders | MedDRA (15.0) |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (15.0) |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
| ||
| Pain | General disorders | MedDRA (15.0) |
| ||
| Paraesthesia | Nervous system disorders | MedDRA (15.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
| ||
| Tremor | Nervous system disorders | MedDRA (15.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Acorda Therapeutics, Inc. | 914-347-4300 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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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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| TEAEs Maximum Severity - Mild |
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| TEAEs Maximum Severity - Moderate |
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| TEAEs Maximum Severity - Severe |
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| TEAEs leading to withdrawal of study drug |
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| TEAEs Serious |
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| Subjects who died |
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