Trial · NCT01468350
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
NCT01468350, Phase 1, Completed, Acorda Therapeutics; results first posted 2014-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy. Trials, record NCT01468350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01468350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
- NCT number
- NCT01468350
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Cerebral Palsy (CP)
- Interventions
- dalfampridine-ER 10mg, Placebo
- First posted
- 2011-11-09
- Last updated
- 2014-06-24
- Results first posted
- 2014-06-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | up to 31 days | 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: * 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 |
| Secondary | Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function | up to 31 days | * Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests * Manual dexterity as measured by the Box and Block Test * Walking speed as measured by the Timed 25 Foot Walk (T25FW) * Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it) * For Part B only, subjective impressions of treatment as measured by: * Subject Global Impression (SGI) * Clinician Global Impression (CGI) |
Source ClinicalTrials.gov
Outcomes2
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 10mg in Subjects With Cerebral Palsy (CP) | up to 31 days | Safety Population (Took at least one dose) | participants | NUMBER |
| SECONDARY | Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function | up to 31 days |
Source ClinicalTrials.gov
Results by group28
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 10mg in Subjects With Cerebral Palsy (CP) | PART A: Placebo | TEAEs | 1 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART A: Dalfampridine-ER 10mg | TEAEs | 2 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART B: Placebo | TEAEs | 6 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART B: Dalfampridine-ER 10mg | TEAEs | 9 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART A: Placebo | Serious TEAEs | 0 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART A: Dalfampridine-ER 10mg | Serious TEAEs | 0 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART B: Placebo | Serious TEAEs | 0 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART B: Dalfampridine-ER 10mg | Serious TEAEs | 0 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART A: Placebo | TEAEs Maximum Severity - Mild | 1 | participants | |
| Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) | PART A: Dalfampridine-ER 10mg | TEAEs Maximum Severity - Mild | 2 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| (PART A) Day 1, Day 3 | STARTED | (PART A) Placebo Then Dalfampridine-ER 10mg | 6 | |
| (PART A) Day 1, Day 3 | STARTED | (PART A) Dalfampridine-ER 10mg Then Placebo | 5 | |
| (PART A) Day 1, Day 3 | STARTED | (PART B) Placebo Then Dalfampridine-ER 10mg | 0 | |
| (PART A) Day 1, Day 3 | STARTED | (PART B) Dalfampridine-ER 10mg Then Placebo | 0 | |
| (PART A) Day 1, Day 3 | COMPLETED | (PART A) Placebo Then Dalfampridine-ER 10mg | 6 | |
| (PART A) Day 1, Day 3 | COMPLETED | (PART A) Dalfampridine-ER 10mg Then Placebo | 5 | |
| (PART A) Day 1, Day 3 | COMPLETED | (PART B) Placebo Then Dalfampridine-ER 10mg | 0 | |
| (PART A) Day 1, Day 3 | COMPLETED | (PART B) Dalfampridine-ER 10mg Then Placebo | 0 | |
| (PART A) Day 1, Day 3 | NOT COMPLETED | (PART A) Placebo Then Dalfampridine-ER 10mg | 0 | |
| (PART A) Day 1, Day 3 | NOT COMPLETED | (PART A) Dalfampridine-ER 10mg Then Placebo | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events64
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 | Headache | Nervous system disorders | PART A: Placebo | 0 | 11 | |
| other | Headache | Nervous system disorders | PART A: Dalfampridine-ER 10mg | 2 | 11 | |
| other | Headache | Nervous system disorders | PART B: Placebo | 1 | 24 | |
| other | Headache | Nervous system disorders | PART B: Dalfampridine-ER 10mg | 3 | 24 | |
| other | Fatigue | General disorders | PART A: Placebo | 1 | 11 | |
| other | Fatigue | General disorders | PART A: Dalfampridine-ER 10mg | 0 | 11 | |
| other | Fatigue | General disorders | PART B: Placebo | 0 | 24 | |
| other | Fatigue | General disorders | PART B: Dalfampridine-ER 10mg | 3 | 24 | |
| other | Insomnia | Psychiatric disorders | PART A: Placebo | 0 | 11 | |
| other | Insomnia | Psychiatric disorders | PART A: Dalfampridine-ER 10mg | 0 | 11 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PART A: Placebo | ||
| Total, all-cause mortality | PART A: Dalfampridine-ER 10mg | ||
| Total, all-cause mortality | PART B: Placebo | ||
| Total, all-cause mortality | PART B: Dalfampridine-ER 10mg | ||
| Total, other adverse events | PART A: Placebo | 1 | 11 |
| Total, other adverse events | PART A: Dalfampridine-ER 10mg | 2 | 11 |
| Total, other adverse events | PART B: Placebo | 6 | 24 |
| Total, other adverse events | PART B: Dalfampridine-ER 10mg | 9 | 24 |
| Total, serious adverse events | PART A: Placebo | 0 | 11 |
| Total, serious adverse events | PART A: Dalfampridine-ER 10mg | 0 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28131322 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01468350
GET https://conductscience.org/api/trials/v1/NCT01468350/results?page=2