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A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (PART A) AB: dalfampridine-ER 10mg then placebo | Placebo Comparator | Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart |
|
| (PART A) BA: placebo then dalfampridine-ER 10mg | Placebo Comparator | Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart |
|
| (PART B) AB: dalfampridine-ER 10mg then placebo | Placebo Comparator | Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo |
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| (PART B) BA: Placebo then dalfampridine-ER 10mg | Placebo Comparator | Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalfampridine-ER 10mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs) TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study. The severity categories of mild, moderate or severe, are defined below:
| up to 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Carrazana, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Rancho Los Amigos National Rehabilitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28131322 | Derived | Bethoux F, Fatemi A, Fowler E, Marciniak C, Mayadev A, Waksman J, Zackowski K, Suarez G, Blight AR, Rabinowicz AL, Carrazana E. Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study. Clin Ther. 2017 Feb;39(2):337-346. doi: 10.1016/j.clinthera.2016.12.015. Epub 2017 Jan 25. |
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Part A, 11 subjects enrolled and randomized. 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) and 5 randomized into Sequence AB (dalfampridine-ER - placebo). Part B, 24 subjects enrolled and randomized. 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) and 12 into Sequence AB (dalfampridine-ER - placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | (PART A) Placebo Then Dalfampridine-ER 10mg | Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| (PART A) Day 1, Day 3 |
|
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| Placebo | Other |
|
| up to 31 days |
| Downey |
| California |
| 90242 |
| United States |
| UCLA/Orthopaedic Hospital Center for Cerebral Palsy | Los Angeles | California | 90095 | United States |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Kennedy Krieger Institute at Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | United States |
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | United States |
| University of Missouri at Columbia | Columbia | Missouri | 65212 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| (PART A) Dalfampridine-ER 10mg Then Placebo |
Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo |
| FG002 | (PART B) Placebo Then Dalfampridine-ER 10mg | Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day |
| FG003 | (PART B) Dalfampridine-ER 10mg Then Placebo | Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day |
| COMPLETED |
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| NOT COMPLETED |
|
| (PART B) Day 1, Day 15 |
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Safety Population (Took at least one dose)
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| ID | Title | Description |
|---|---|---|
| BG000 | (PART A) Placebo Then Dalfampridine-ER 10mg | Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg |
| BG001 | (PART A) Dalfampridine-ER 10mg Then Placebo | Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo |
| BG002 | (PART B) Placebo Then Dalfampridine-ER 10mg | Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day |
| BG003 | (PART B) Dalfampridine-ER 10mg Then Placebo | Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 10mg in Subjects With Cerebral Palsy (CP) | Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs) TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study. The severity categories of mild, moderate or severe, are defined below:
| Safety Population (Took at least one dose) | Posted | Number | participants | up to 31 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function |
| Not Posted | up to 31 days |
Up to 31 days
Part A: up to 8 days Part B: up to 31 days
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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 | PART A: Placebo | 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo) A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart | 0 | 11 | 1 | 11 | ||
| EG001 | PART A: Dalfampridine-ER 10mg | 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo) A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart | 0 | 11 | 2 | 11 | ||
| EG002 | PART B: Placebo | 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo) Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg | 0 | 24 | 6 | 24 | ||
| EG003 | PART B: Dalfampridine-ER 10mg | 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo) Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg | 0 | 24 | 9 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (14.1) |
| ||
| Fatigue | General disorders | MedDRA (14.1) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (14.1) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (14.1) |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) |
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| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA (14.1) |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) |
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| Somnolence | Nervous system disorders | MedDRA (14.1) |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.1) |
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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 | |
|---|---|---|---|---|
| Vice President - Clinical Development & Medical Affairs | Acorda Therapeutics, Inc. | 914-347-4300 | hhenney@acorda.com |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System 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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| Serious TEAEs |
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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 Possibly Related to Study Drug |
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| TEAEs Leading to Withdrawal of Study Drug |
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