NCT01656148 (FAME) is a Phase 4 clinical trial of Fampridine-SR in Multiple Sclerosis, sponsored by University of Southern Denmark.

Who is sponsoring NCT01656148?

NCT01656148 is sponsored by University of Southern Denmark.

What drugs are being tested in NCT01656148?

Interventions in NCT01656148: Fampridine-SR.

What condition does NCT01656148 study?

NCT01656148 studies Multiple Sclerosis.

Is NCT01656148 still recruiting?

NCT01656148 is currently completed. Last updated 22 August 2018.

Last reviewed 2018-08-22 · How we verify

NCT01656148: FAME

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Completed Phase 4 Last updated 22 August 2018

What this trial tests

Phase 4 trial testing Fampridine-SR in Multiple Sclerosis in 108 participants. Completed in 1 May 2014.

Timeline

1 June 2012

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	University of Southern Denmark
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	108
Start date	1 June 2012
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	4 locations across Denmark

Drugs / interventions tested

Fampridine-SR — full drug profile →

Conditions studied

Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of Southern Denmark

Who can join

Adults 18 to 60, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Changes in cognition, arm function and lower body function after slow-release Fampridine treatment.
Jensen H, Ravnborg M, Mamoei S, Dalgas U, et al · · 2014 · cited 48× · PMID 24852920 · DOI 10.1177/1352458514533844
Effect of slow release-Fampridine on muscle strength, rate of force development, functional capacity and cognitive function in an enriched population of MS patients. A randomized, double blind, placebo controlled study.
Jensen HB, Nielsen JL, Ravnborg M, Dalgas U, et al · · 2016 · cited 26× · PMID 27919481 · DOI 10.1016/j.msard.2016.07.019

Verify or expand the search:

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other University of Southern Denmark trials

Trials by the same sponsor.

NCT07531290 — PeerScreen Trial - Reducing Screen Media Use in Peer-groups of Young People · NA · not yet recruiting
NCT07384273 — Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression · NA · recruiting
NCT07426679 — Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia? · NA · recruiting
NCT07104292 — Pelvic Floor Muscle Training During Pregnancy · NA · recruiting
NCT07194759 — Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01656148 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Southern Denmark
Last refreshed: 22 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01656148.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing