Trial · NCT00649792
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
NCT00649792, 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 in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial. Trials, record NCT00649792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00649792
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 Who Participated in the MS-F204 Trial
- NCT number
- NCT00649792
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Multiple Sclerosis
- Interventions
- Fampridine-SR
- First posted
- 2008-04-01
- Last updated
- 2012-02-28
- 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 40 months | 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 thereafter (other than the follow-up visit) | 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's Global Impression (CGI) | Visit 1 and every clinic visit thereafter | 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) | The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) | The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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/seconds | MEAN |
| SECONDARY | Subject Global Impression (SGI) | Visit 1 and every clinic visit thereafter (other than the follow-up visit) | ITT Population. No imputation for missing data | 1-7 scale rating | MEAN |
| SECONDARY | Clinician's Global Impression (CGI) | Visit 1 and every clinic visit thereafter | ITT Population. No imputation for missing data | 1-7 scale rating | MEAN |
| SECONDARY | Expanded Disability Status Scale (EDSS) | The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) | ITT Population. No imputation for missing data | 0-10 rating scale | MEAN |
| PRIMARY | Summary of Treatment Emergent Adverse Events (TEAE). | up to 40 months | Safety Population. No imputation for missing data | participants | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=209) >0-8 Weeks | 2.60 | Standard Deviation 0.86 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=197) >8-16 Weeks | 2.53 | Standard Deviation 0.93 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=201) >16-42 Weeks | 2.52 | Standard Deviation 0.96 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=172) >42-68 Weeks | 2.46 | Standard Deviation 1.02 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=160) >68-94 Weeks | 2.37 | Standard Deviation 1.04 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=151) >94-120 Weeks | 2.35 | Standard Deviation 1.10 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=143) >120-146 Weeks | 2.27 | Standard Deviation 1.06 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=33) >146-172 Weeks | 2.17 | Standard Deviation 1.07 | feet/seconds |
| Timed 25-Foot Walk (T25FW) | Fampridine-SR | (N=2) >172-198 Weeks | 1.85 | Standard Deviation 0.56 | feet/seconds |
| Subject Global Impression (SGI) | Fampridine-SR | (N=214) >0-8 Weeks | 4.67 | Standard Deviation 1.15 | 1-7 scale rating |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 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 | 214 | |
| Overall Study | COMPLETED | Fampridine-SR | 146 | |
| Overall Study | NOT COMPLETED | Fampridine-SR | 68 |
Source ClinicalTrials.gov
Adverse events74
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 | 18 | 214 | 24 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fampridine-SR | 33 | 214 | 43 |
| other | Asthenia | General disorders | Fampridine-SR | 12 | 214 | 14 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Fampridine-SR | 23 | 214 | 30 |
| other | Balance Disorder | Nervous system disorders | Fampridine-SR | 23 | 214 | 29 |
| other | Blood Creatine Phosphokinase Increased | Investigations | Fampridine-SR | 13 | 214 | 15 |
| other | Contusion | Injury, poisoning and procedural complications | Fampridine-SR | 30 | 214 | 40 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fampridine-SR | 11 | 214 | 11 |
| other | Depression | Psychiatric disorders | Fampridine-SR | 14 | 214 | 19 |
| other | Dizziness | Nervous system disorders | Fampridine-SR | 24 | 214 | 30 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 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 | 205 | 214 |
| Total, serious adverse events | Fampridine-SR | 39 | 214 |
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/NCT00649792
GET https://conductscience.org/api/trials/v1/NCT00649792/results?page=2