Trial · NCT00654927
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
NCT00654927, Phase 3, Completed, Acorda Therapeutics; results first posted 2012-02-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis. Trials, record NCT00654927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
- NCT number
- NCT00654927
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 177 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Multiple Sclerosis
- Interventions
- Fampridine-SR b.i.d. (Twice Daily)
- First posted
- 2008-04-09
- Last updated
- 2012-03-02
- Results first posted
- 2012-02-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Treatment Emergent Adverse Events (TEAE). | over 7 years (2004-2011) | All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events. |
| Secondary | Timed 25 Foot Walk (T25FW) | Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit | |
| Secondary | Subject Global Impression (SGI) | visit 1 and every clinic visit | The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted) |
| Secondary | Clinician Global Impression of Change (CGIC) | visit 1 and every clinic visit | The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse) |
| Secondary | Expanded Disability Status Scale (EDSS) | Screening visit, visit 6 and every 24 months thereafter | Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death) \*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Treatment Emergent Adverse Events (TEAE). | over 7 years (2004-2011) | Safety Population. No imputation for missing data | participants | NUMBER |
| SECONDARY | Timed 25 Foot Walk (T25FW) | Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit | ITT Population. No imputation for missing data | feet/second | MEAN |
| SECONDARY | Subject Global Impression (SGI) | visit 1 and every clinic visit | ITT Population. No imputation for missing data | units on a scale | MEAN |
| SECONDARY | Clinician Global Impression of Change (CGIC) | visit 1 and every clinic visit | ITT Population. No imputation for missing data | units on a scale | MEDIAN |
| SECONDARY | Expanded Disability Status Scale (EDSS) | Screening visit, visit 6 and every 24 months thereafter | ITT Population. No imputation for data missing | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Patients with Any AE | 176 | 99.4 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Patients with Any Serious AE | 65 | 36.7 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Patients with Any Possibly/Probably Related AE | 102 | 41.8 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Patients withdrawn due to AE | 34 | 15.3 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Patients who Died | 5 | 2.3 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Maximum Severity/Patients with Any TEAE -Mild | 10 | 8.5 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Maximum Severity/Patients with Any TEAE -Moderate | 66 | 38.4 | participants |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR b.i.d. | Maximum Severity/Patients with Any TEAE -Severe | 100 | 47.5 | participants |
| Timed 25 Foot Walk (T25FW) | Fampridine-SR b.i.d. | (N=153) Baseline | 1.87 | Standard Deviation 0.94 | feet/second |
| Timed 25 Foot Walk (T25FW) | Fampridine-SR b.i.d. | (N=1) >0-8 Weeks | 1.98 | Standard Deviation NA | feet/second |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fampridine-SR b.i.d. (Twice Daily) | 177 | |
| Overall Study | COMPLETED | Fampridine-SR b.i.d. (Twice Daily) | 70 | |
| Overall Study | NOT COMPLETED | Fampridine-SR b.i.d. (Twice Daily) | 107 |
Source ClinicalTrials.gov
Adverse events152
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 | Adverse Drug Reaction | General disorders | Fampridine-SR b.i.d. (Twice Daily) | 19 | 177 | 26 |
| other | Anxiety | Psychiatric disorders | Fampridine-SR b.i.d. (Twice Daily) | 13 | 177 | 13 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fampridine-SR b.i.d. (Twice Daily) | 34 | 177 | 49 |
| other | Asthenia | General disorders | Fampridine-SR b.i.d. (Twice Daily) | 32 | 177 | 44 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Fampridine-SR b.i.d. (Twice Daily) | 30 | 177 | 48 |
| other | Balance Disorder | Nervous system disorders | Fampridine-SR b.i.d. (Twice Daily) | 17 | 177 | 24 |
| other | Blood Cholesterol Increased | Investigations | Fampridine-SR b.i.d. (Twice Daily) | 13 | 177 | 15 |
| other | Blood Creatine Phosphokinase Increased | Investigations | Fampridine-SR b.i.d. (Twice Daily) | 11 | 177 | 14 |
| other | Blood Triglycerides Increased | Investigations | Fampridine-SR b.i.d. (Twice Daily) | 9 | 177 | 9 |
| other | Bronchitis | Infections and infestations | Fampridine-SR b.i.d. (Twice Daily) | 10 | 177 | 14 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fampridine-SR b.i.d. (Twice Daily) | ||
| Total, other adverse events | Fampridine-SR b.i.d. (Twice Daily) | 176 | 177 |
| Total, serious adverse events | Fampridine-SR b.i.d. (Twice Daily) | 65 | 177 |
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 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/NCT00654927
GET https://conductscience.org/api/trials/v1/NCT00654927/results?page=2