Trial · NCT01605825
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
NCT01605825, Phase 2, Completed, Acorda Therapeutics; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke. Trials, record NCT01605825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01605825
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
- NCT number
- NCT01605825
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Ischemic Stroke
- Interventions
- placebo/dalfampridine-ER, dalfampridine-ER/placebo
- First posted
- 2012-05-25
- Last updated
- 2016-01-22
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | up to 36 days | 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 |
| Other | Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) | Screening visit, Days 1, 8, 15, 22, 29 and 36 | |
| Other | Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA) | Screening visit, Days 1, 8, 15, 22, 29, and 36 | |
| Other | Manual Dexterity as Measured by the Box and Block Test | Days 1, 8, 15, 22, 29, and 36 | |
| Other | Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale | Days 1, 8, 15, 22, 29, and 36 | |
| Other | Subject Global Impression (SGI) Scale | Days 8, 15, 22, 29 and 36 | |
| Other | Clinician Global Impression (CGI) Scale | Days 8, 15, 22, 29 and 36 | |
| Other | Hand Strength as Measured by the Grip Test and Pinch Tests | Days 1, 8, 15, 22, 29, and 36 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | up to 36 days | 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. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) | 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) | Screening visit, Days 1, 8, 15, 22, 29, and 36 | |||
| OTHER_PRE_SPECIFIED | Manual Dexterity as Measured by the Box and Block Test | 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 | Days 1, 8, 15, 22, 29, and 36 | |||
| OTHER_PRE_SPECIFIED | Subject Global Impression (SGI) Scale | Days 8, 15, 22, 29 and 36 | |||
| OTHER_PRE_SPECIFIED | Clinician Global Impression (CGI) Scale | Days 8, 15, 22, 29 and 36 | |||
| OTHER_PRE_SPECIFIED | Hand Strength as Measured by the Grip Test and Pinch Tests | Days 1, 8, 15, 22, 29, and 36 |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Placebo | Subjects with any TEAEs | 30 | participants | |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Dalfampridine-ER | Subjects with any TEAEs | 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) | Placebo | TEAEs Possibly Related to study drug | 16 | participants | |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Dalfampridine-ER | TEAEs Possibly Related to study drug | 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) | Placebo | TEAEs Maximum Severity - Mild | 16 | participants | |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Dalfampridine-ER | TEAEs Maximum Severity - Mild | 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) | Placebo | TEAEs Maximum Severity - Moderate | 13 | participants | |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Dalfampridine-ER | TEAEs Maximum Severity - Moderate | 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) | Placebo | TEAEs Maximum Severity - Severe | 1 | participants | |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | Dalfampridine-ER | TEAEs Maximum Severity - Severe | 3 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Dalfampridine-ER | 55 | |
| Overall Study | STARTED | Dalfampridine-ER/Placebo | 28 | |
| Overall Study | COMPLETED | Placebo/Dalfampridine-ER | 45 | |
| Overall Study | COMPLETED | Dalfampridine-ER/Placebo | 25 | |
| Overall Study | NOT COMPLETED | Placebo/Dalfampridine-ER | 10 | |
| Overall Study | NOT COMPLETED | Dalfampridine-ER/Placebo | 3 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Placebo | 2 | 81 | |
| other | Dizziness | Nervous system disorders | Dalfampridine-ER | 8 | 77 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 81 | |
| other | Nausea | Gastrointestinal disorders | Dalfampridine-ER | 3 | 77 | |
| other | Fatigue | General disorders | Placebo | 3 | 81 | |
| other | Fatigue | General disorders | Dalfampridine-ER | 4 | 77 | |
| other | Insomnia | Psychiatric disorders | Placebo | 2 | 81 | |
| other | Insomnia | Psychiatric disorders | Dalfampridine-ER | 4 | 77 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 3 | 81 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dalfampridine-ER | 2 | 77 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dalfampridine-ER | ||
| Total, other adverse events | Placebo | 30 | 81 |
| Total, other adverse events | Dalfampridine-ER | 42 | 77 |
| Total, serious adverse events | Placebo | 2 | 81 |
| Total, serious adverse events | Dalfampridine-ER | 2 | 77 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23652269 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dalfampridine-ER vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01605825
GET https://conductscience.org/api/trials/v1/NCT01605825/events?page=2