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Multiple SclerosisPhase 4RETRAPNCT02143167

Resistance Training and Amino Pyridine in Multiple Sclerosis

A Phase 4 study testing SR-fampridine in people with Multiple Sclerosis, run by University of Southern Denmark at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
SR-fampridine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
4 sitesDenmark
Study dates
May 2014to Jan 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
  • Expandend Disability Status Scale (EDSS) 3-6.5
  • Pyramidal Functional Score ≥ 2
  • Participants must be able to transport self to gym and to the University of Southern Denmark
  • Participants must be able to complete T25FW and SSST
  • Fertile female participants are obliged to use hormonal contraceptive measures

Who cannot join

  • History of epileptic seizures
  • MS relapse or change in disease modifying treatment (DMT) within 60 days
  • Cancer within five years
  • Blood pressure ≥ 160/100
  • Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
  • ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
Show all 12Show fewer
  • GFR < 80 ml/min.
  • History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
  • Pregnancy
  • Breastfeeding
  • Allergy to substances contained in prolonged release Fampridine tablets
  • Concomitant treatment with carvedilol, propranolol or metformin.

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Odense University Hospital

    Odense, 5000

  • Sygehus Sønderjylland

    Sønderborg, 6400

  • Sygehus Lillebælt

    Vejle, 7100

Other trials in Denmark

About this study

Official title: RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis

Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination.

Resistance training has been shown to provide the same kind of benefits for patients by targeting the muscular component of the motor unit. Thus by combining the two it is likely to see an synergistic effect.

Read more

This trial is designed as a double blind, randomized placebo controlled trial with subsequent cross-over.

Participants in the two arms will go through the same progressive training program targets at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives placebo. in the the end there is another four weeks of training after cross-over has been performed.

Read the detailed description

See above

Being tested
SR-fampridine, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR-fampridineDrug

    Also called Fampyra

    One arm receives SR-fampridine 10 mg BID for 24 weeks followed by four weeks of inactive placebo BID.

    The other arm receives placebo BID for 24 weeks followed by four weeks of SR-fampridine 10 mg BID for four weeks.

  • PlaceboDrug

Study groups in NCT02143167
Study groupRoleWhat they receive
SR-fampridine/placeboExperimental24 weeks of SR-fampridine followed by four weeks of inactive placebo.
Receives: Drug: SR-fampridine; Drug: Placebo
Placebo/SR-fampridineExperimental24 weeks of inactive placebo followed by four weeks of SR-fampridine
Receives: Drug: SR-fampridine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle power in the lower limbs

    Muscle power in the lower limbs is measured by dynamometry pre and post resistance training

    Measured: Muscle power will be measured after 14 weeks of resistance training.

Secondary outcomes (5)

  1. Activity

    Activity measured by accelerometry.

    Measured: Accelerometry is measured after 14 weeks of resistance training

  2. Walking capacity

    Walking capacity measured by the Six Spot Step Test (SSST)

    Measured: Walking capacity is measured after 26 weeks of resistance training

  3. Walking speed

    Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)

    Measured: Walking speed is measured after 26 weeks of resistance training

  4. Functional capacity in the lower limbs

    Functional capacity measured by the Chair Stand Test (CST)

    Measured: Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training

  5. Self rated walking capacity

    Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)

    Measured: Self rated walking capacity is measured after 26 weeks of resistance training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02143167
Sponsor's protocol ID
RETRAP
Other IDs
2011-002959-34
Acronym
RETRAP
Status last verified
Aug 2018
First submitted
9 May 2014
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.

    PubMed 19884575

  • Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.

    PubMed 20976768

  • Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.

    PubMed 19249634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SR-fampridine in people with Multiple Sclerosis, run by University of Southern Denmark at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle power in the lower limbs (time frame: Muscle power will be measured after 14 weeks of resistance training.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02143167, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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