---
title: "FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra"
nct_id: NCT01656148
overall_status: COMPLETED
phase: PHASE4
sponsor: University of Southern Denmark
study_type: INTERVENTIONAL
primary_condition: Multiple Sclerosis
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01656148.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01656148"
ct_last_update_post_date: 2018-08-23
last_seen_at: "2026-05-12T06:44:16.784Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

**Official Title:** Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

**NCT ID:** [NCT01656148](https://clinicaltrials.gov/study/NCT01656148)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** University of Southern Denmark
- **Collaborators:** Region of Southern Denmark, Biogen
- **Conditions:** Multiple Sclerosis
- **Start Date:** 2012-06
- **Completion Date:** 2014-05
- **CT.gov Last Update:** 2018-08-23

## Brief Summary

Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.

The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.

Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
* EDSS 4-7
* Pyramidal FS \>= 2

Exclusion Criteria:

* History of epileptic seizures
* MS relapse or change in disease modifying treatment (DMT) within 60 days
* cancer within five years
* uncontrolled hypertension
* clinically important cardiac, hepatic, renal or pulmonary disease
* pregnancy
* breast feeding
* concomitant treatment with cimetidine, carvedilol, propranolol and metformin
```

## Arms

- **Fampridine-SR** (EXPERIMENTAL) — Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks.
- **Placebo** (PLACEBO_COMPARATOR) — In the intervention phase 50% will receive placebo BID

## Interventions

- **Fampridine-SR** (DRUG) — Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.

## Primary Outcomes

- **The mean change in SSST** _(time frame: SSST is measured before and at the end of four weeks of treatment)_ — SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.

## Secondary Outcomes

- **Mean change in T25FW** _(time frame: Four weeks)_
- **Mean change in hip flexion, knee flexion and knee extension force** _(time frame: Four weeks)_
- **Mean change on Chair Rise Test** _(time frame: Four weeks)_
- **Mean change on 9-Hole Peg Test (9HPT)** _(time frame: Four weeks)_
- **Mean change on Symbol Digit Modalitites Test (SDMT)** _(time frame: Four weeks)_

## Locations (4)

- Esbjerg Hospital, Esbjerg, Denmark
- Odense University Hospital, Odense, Denmark
- Sønderborg Hospital, Sønderborg, Denmark
- Vejle Hospital, Vejle, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.esbjerg hospital|esbjerg||denmark` — added _(2026-05-12)_
- `locations.odense university hospital|odense||denmark` — added _(2026-05-12)_
- `locations.sønderborg hospital|sønderborg||denmark` — added _(2026-05-12)_
- `locations.vejle hospital|vejle||denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01656148.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01656148*  
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