Trial · NCT02208050
A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
NCT02208050, Phase 4, Completed, University College Dublin; results first posted 2021-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS. Trials, record NCT02208050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02208050
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
- NCT number
- NCT02208050
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 64 participants, actual
- Lead sponsor
- University College Dublin
- Conditions
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- Interventions
- Fampridine, Placebo
- First posted
- 2014-08-04
- Last updated
- 2021-07-09
- Results first posted
- 2021-07-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | 20 weeks. Baseline assessments 1,2,3: weeks 0-2. Assessment 4 - midway through first treatment period; assessment 5: end of first treatment period. Assessment 7: midway through second treatment period, assessment 8: end of second treatment period. | 9 Hole Peg Test is a test of upper limb function. Participants place 9 pegs on pegboard and remove pegs - this is timed for each hand. Time recorded in seconds. Longer time indicates poorer upper limb function. 20% improvement is defined as 20% shorter time in seconds. An upper limb responder is defined as a patient with both of the two "on treatment" 9 Hole Peg Test (9-HPT) assessments measured in seconds (assessments 4 \& 5 or 7 \& 8) improving 20% from the average of the baseline assessments (1, 2 \& 3). Washout assessment not included in the analysis. |
| Secondary | Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) | 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8 | Jebsen Taylor Hand Function Test (JTT) is a timed test (seconds) comprising of seven 'real-world' tasks such as picking up small items. It has been validated for use in upper limb function in MS. A secondary measure of upper limb responsiveness will be defined as number of participants with a 20% improvement in from baseline in the average time taken to complete all seven tasks on the Jebsen Taylor Hand Function Test "on treatment" (assessments 4 \& 5 or 7 \& 8) compared with baseline assessments (assessments 1,2 \& 3). Baseline assessments (1,2,3) performed in two week period prior to first treatment block. Longer time indicates worse functioning. Improvement is defined as shorter time in seconds. Assessment 4: Midway through first treatment period (week 4 of 8 week treatment period) Assessment 5: End of first treatment period (end of week 8) Assessment 7: Midway through second treatment period Assessment 8: End of second treatment period |
| Secondary | The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) | 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8 | A mobility responder to Fampridine will be defined as a patient with both of the two "on treatment" T25FW assessments (assessments 4 \& 5 or 7 \& 8) being better (shorter time in seconds) than the maximum of any of the four "off treatment" assessments (assessments 1, 2, 3, 6). Otherwise the patient will be deemed a non-responder. T25FW test is the time taken to walk 25 feet taken as the average of two trials. Measured in seconds. Longer time indicates slower walking. Improvement is considered shorter amount of time in seconds - no specific percentage or amount of time was considered necessary. Assessment 4: Midway through first treatment period (week 4 of 8 week treatment period) Assessment 5: End of first treatment period (end of week 8) Assessment 7: Midway through second treatment period Assessment 8: End of second treatment period. |
| Secondary | Mean Scores in DASH - Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Disabilities of the Arm Shoulder and Hand Scores questionnaire: The DASH consists of a 30-item disability symptom scale scored 0 (no disability) to 100, developed as a self-rated upper extremity disability and symptoms. Higher scores indicate higher self-perception of disability. DASH questionnaire administered to fampridine treated group at Weeks 6,10,16 and 20. Scores at each time point were summed and averaged. DASH questionnaire administered to placebo treated group at Weeks 6,10,16 and 20. Scores at each time point were summed and averaged. |
| Secondary | Mean Scores in Multiple Sclerosis Walking Scale (MSWS-12) - Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Multiple Sclerosis Walking Scale 12 is a 12-item self report measure of the impact of MS on an individual's walking ability. Scores are summed 1-3; 1-5 for each item. Higher scores indicate higher limitation in walking ability. Scores are summed and transformed to a 0-100 scale again with higher scores indicating higher self-reported limitation in walking ability. MSWS12 scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the 4 scores was averaged. MSWS-12 scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the 4 scores was averaged. |
| Secondary | Mean Scores in the Disabilities in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Score Between Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | AMSQ - Arm Function in Multiple Sclerosis Questionnaire. This is a 31-item patient reported outcome measure which is validated to measure limitation in arm and hand functioning in people with multiple sclerosis. Patients rate the ability to which they can perform routine daily tasks with current hand function. Higher scores indicate greater limitations. Scale ranges from 0-100. AMSQ scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the 4 scores was averaged. AMSQ scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the 4 scores was averaged. |
| Secondary | Mean Scores of MSIS-29 - Fampridine and Placebo | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | MSIS-29 is a patient reported outcome with a physical and psychological component combined into one scale. They refer to the self-reported impact of MS on their physical and psychological wellbeing. Higher scores indicate a higher impact on functioning. The 20 item physical scale and the 9 item psychological scale are reported as two separate scaled scores. Both scale ranges are 0-100. Higher scores indicate a higher impact on functioning. MSIS -20 and MSIS-9 scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the scores was averaged. MMSIS-20 and MSIS-9 scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the scores was averaged. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | 20 weeks. Baseline assessments 1,2,3: weeks 0-2. Assessment 4 - midway through first treatment period; assessment 5: end of first treatment period. Assessment 7: midway through second treatment period, assessment 8: end of second treatment period. | Analysis population included all participants who received treatment and placebo for eight weeks. Two participants withdrew during the second 8-week treatment period and were not included in the final analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) | 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8 | Participants who had completed assessments at the above time points to allow analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) | 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8 | Population with 25 foot walk data on analysis of results. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Scores in DASH - Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Mean scores in the DASH for all participants in the trial during on treatment periods (assessments 4\&5; 7\&8). | Mean units on a scale. | MEAN |
| SECONDARY | Mean Scores in Multiple Sclerosis Walking Scale (MSWS-12) - Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Participants on treatment with Fampridine or Placebo. | units on a scale | MEAN |
| SECONDARY | Mean Scores in the Disabilities in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Score Between Fampridine and Placebo. | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Mean scores on AMSQ during on-treatment period. (AMSQ assessments 4 \& 5, 7 \& 8). | units on a scale | MEAN |
| SECONDARY | Mean Scores of MSIS-29 - Fampridine and Placebo | 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period. | Participants during on-treatment period with fampridine or placebo. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | PR-Fampridine | Dominant hand / Responders | 4 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | Placebo | Dominant hand / Responders | 3 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | PR-Fampridine | Dominant hand / Non-responders | 58 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | Placebo | Dominant hand / Non-responders | 59 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | PR-Fampridine | Non-dominant hand / Responders | 2 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | Placebo | Non-dominant hand / Responders | 1 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | PR-Fampridine | Non-dominant hand / Non-responders | 60 | Participants | |
| Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) | Placebo | Non-dominant hand / Non-responders | 61 | Participants | |
| Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) | Fampridine | Dominant hand / Responders | 3 | Participants | |
| Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) | Placebo | Dominant hand / Responders | 0 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Assessment Period: 2 Weeks | STARTED | Group A: Fampridine Followed by Placebo | 36 | |
| Baseline Assessment Period: 2 Weeks | STARTED | Group B: Placebo Followed by Fampridine | 28 | |
| Baseline Assessment Period: 2 Weeks | COMPLETED | Group A: Fampridine Followed by Placebo | 36 | |
| Baseline Assessment Period: 2 Weeks | COMPLETED | Group B: Placebo Followed by Fampridine | 28 | |
| Baseline Assessment Period: 2 Weeks | NOT COMPLETED | Group A: Fampridine Followed by Placebo | 0 | |
| Baseline Assessment Period: 2 Weeks | NOT COMPLETED | Group B: Placebo Followed by Fampridine | 0 | |
| Treatment Period 1: 8 Weeks Treatment | STARTED | Group A: Fampridine Followed by Placebo | 36 | |
| Treatment Period 1: 8 Weeks Treatment | STARTED | Group B: Placebo Followed by Fampridine | 28 | |
| Treatment Period 1: 8 Weeks Treatment | COMPLETED | Group A: Fampridine Followed by Placebo | 36 | |
| Treatment Period 1: 8 Weeks Treatment | COMPLETED | Group B: Placebo Followed by Fampridine | 28 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events72
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 | Peripheral venous disease | Vascular disorders | Fampridine | 1 | 64 | 1 |
| other | Peripheral venous disease | Vascular disorders | Placebo | 0 | 64 | 0 |
| other | Laceration to Foot | Injury, poisoning and procedural complications | Fampridine | 0 | 64 | |
| other | Laceration to Foot | Injury, poisoning and procedural complications | Placebo | 1 | 64 | |
| other | Fall | Injury, poisoning and procedural complications | Fampridine | 1 | 64 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 2 | 64 | |
| other | Elevated hepatic enzymes | Investigations | Fampridine | 3 | 64 | |
| other | Elevated hepatic enzymes | Investigations | Placebo | 4 | 64 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fampridine | 2 | 64 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 64 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fampridine | 0 | 64 |
| Total, all-cause mortality | Placebo | 0 | 64 |
| Total, other adverse events | Fampridine | 32 | 64 |
| Total, other adverse events | Placebo | 25 | 64 |
| Total, serious adverse events | Fampridine | 0 | 64 |
| Total, serious adverse events | Placebo | 0 | 64 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fampridine vs Placebo: deaths from any cause | Trial comparisons |
| Fampridine vs Placebo: serious adverse events | 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.
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