Trial · NCT00041717
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
NCT00041717, Phase 3, Completed, Acorda Therapeutics; results first posted 2013-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury. Trials, record NCT00041717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00041717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
- NCT number
- NCT00041717
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 213 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Spinal Cord Injury, Muscle Spasticity
- Interventions
- Fampridine-SR, Placebo
- First posted
- 2002-07-16
- Last updated
- 2020-01-14
- Results first posted
- 2013-05-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 | The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement. |
| Primary | Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 | This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome. |
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 | Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 | Intent to treat (ITT) population | units on a scale | MEAN |
| PRIMARY | Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 | ITT | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | Fampridine-SR 50mg/Day | -0.19 | Standard Error 0.039 | units on a scale | |
| Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | Placebo | -0.15 | Standard Error 0.042 | units on a scale | |
| Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | Fampridine-SR 50mg/Day | -0.2 | Standard Error 0.08 | units on a scale | |
| Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | Placebo | -0.1 | Standard Error 0.09 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fampridine-SR 50mg/Day | 114 | |
| Overall Study | STARTED | Placebo | 98 | |
| Overall Study | COMPLETED | Fampridine-SR 50mg/Day | 81 | |
| Overall Study | COMPLETED | Placebo | 86 | |
| Overall Study | NOT COMPLETED | Fampridine-SR 50mg/Day | 33 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events154
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 | Urinary tract infection | Infections and infestations | Fampridine-SR 50mg/Day | 34 | 114 | 42 |
| other | Urinary tract infection | Infections and infestations | Placebo | 16 | 98 | 20 |
| other | Hypertonia | Nervous system disorders | Fampridine-SR 50mg/Day | 23 | 114 | 31 |
| other | Hypertonia | Nervous system disorders | Placebo | 25 | 98 | 35 |
| other | Constipation | Gastrointestinal disorders | Fampridine-SR 50mg/Day | 11 | 114 | 18 |
| other | Constipation | Gastrointestinal disorders | Placebo | 8 | 98 | 9 |
| other | Dizziness | Vascular disorders | Fampridine-SR 50mg/Day | 15 | 114 | 18 |
| other | Dizziness | Vascular disorders | Placebo | 3 | 98 | 4 |
| other | Pain | General disorders | Fampridine-SR 50mg/Day | 13 | 114 | 18 |
| other | Pain | General disorders | Placebo | 14 | 98 | 18 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fampridine-SR 50mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Fampridine-SR 50mg/Day | 94 | 114 |
| Total, other adverse events | Placebo | 84 | 98 |
| Total, serious adverse events | Fampridine-SR 50mg/Day | 6 | 114 |
| Total, serious adverse events | Placebo | 6 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Fampridine-SR 50mg/Day 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/NCT00041717
GET https://conductscience.org/api/trials/v1/NCT00041717/events?page=2