Trial · NCT00648908
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
NCT00648908, Phase 3, Completed, Acorda Therapeutics; results first posted 2012-02-27
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 Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial. Trials, record NCT00648908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00648908
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 Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
- NCT number
- NCT00648908
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 269 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Multiple Sclerosis
- Interventions
- Fampridine-SR
- First posted
- 2008-04-01
- Last updated
- 2012-02-27
- Results first posted
- 2012-02-27
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). | up to 5 years | 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) | Week 2, 14, 26, continuing every 26 weeks until the Final Visit | |
| Secondary | Subject Global Impression (SGI) | visit 1 and every clinic visit | Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS). For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted. |
| Secondary | Clinician Global Impression of Change (CGIC) | visit 1 and every clinic visit | Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS. The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse. |
| Secondary | Expanded Disability Status Scale (EDSS) | Screening visit, visit 6 and every 24 months thereafter | Each patient, based on their baseline neurological exam, are scored according to the EDSS The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable. |
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). | up to 5 years | Safety Population. No imputation for missing data | Participants | NUMBER |
| SECONDARY | Timed 25 Foot Walk (T25FW) | Week 2, 14, 26, continuing every 26 weeks until the Final 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 | MEAN |
| SECONDARY | Expanded Disability Status Scale (EDSS) | Screening visit, visit 6 and every 24 months thereafter | ITT Population. No imputation for missing data | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group47
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 10mg (Twice a Day) | Patients with Any TEAE | 264 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Patients with Any Serious AE | 94 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Patients with Any Possibly/Probably Related AE | 77 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Patients Withdrawn due to AE | 37 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Patients who Died | 4 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Maximum Severity /Patients with Any Mild TEAE | 16 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Maximum Severity /Patients with Any Moderate TEAE | 137 | Participants | |
| Summary of Treatment Emergent Adverse Events (TEAE). | Fampridine-SR 10mg (Twice a Day) | Maximum Severity /Patients with Any Severe TEAE | 111 | Participants | |
| Timed 25 Foot Walk (T25FW) | Fampridine-SR 10mg (Twice a Day) | (N=265) >0-8 Weeks | 2.35 | Standard Deviation 0.96 | feet/second |
| Timed 25 Foot Walk (T25FW) | Fampridine-SR 10mg (Twice a Day) | (N=242) >8-16 Weeks | 2.27 | Standard Deviation 0.95 | feet/second |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 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 | 269 | |
| Overall Study | COMPLETED | Fampridine-SR | 154 | |
| Overall Study | NOT COMPLETED | Fampridine-SR | 115 |
Source ClinicalTrials.gov
Adverse events148
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 | 22 | 269 | 37 |
| other | Anxiety | Psychiatric disorders | Fampridine-SR | 16 | 269 | 19 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fampridine-SR | 66 | 269 | 93 |
| other | Asthenia | General disorders | Fampridine-SR | 41 | 269 | 50 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Fampridine-SR | 45 | 269 | 56 |
| other | Balance Disorder | Nervous system disorders | Fampridine-SR | 18 | 269 | 20 |
| other | Blood Cholesterol Increased | Investigations | Fampridine-SR | 14 | 269 | 17 |
| other | Cellulitis | Infections and infestations | Fampridine-SR | 15 | 269 | 20 |
| other | Constipation | Gastrointestinal disorders | Fampridine-SR | 27 | 269 | 30 |
| other | Contusion | Injury, poisoning and procedural complications | Fampridine-SR | 31 | 269 | 46 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fampridine-SR | ||
| Total, other adverse events | Fampridine-SR | 264 | 269 |
| Total, serious adverse events | Fampridine-SR | 94 | 269 |
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/NCT00648908
GET https://conductscience.org/api/trials/v1/NCT00648908/results?page=2