CompletedPhase 2MS (type not specified)2015-000182-31

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“Fampridine significantly reduced both PV-VDI (-17.4%, 95% CI: -22.4%, -12.1%; P < 0.0001) and FPA-VDI (-12.5%, 95% CI: -18.9%, -5.5%; P < 0.01).”
Read by software from the paper's abstract

change of peak velocity versional dysconjugacy index (PV-VDI) and first-pass amplitude VDI (FPA-VDI)

mean change difference (fampridine vs placebo) in PV-VDI -17.4% (95% CI -22.4%–-12.1%)

p = < 0.0001 (PV-VDI); P < 0.01 (FPA-VDI)

Read by software from the paper's abstract

What was tested

Treatment tested

What it measured

Main measures

  • Primary endpoints

Other measures (1)

  • Secondary endpoints

Who could take part

MS (type not specified)

Inclusion: 1. Male and female patients 18 years or more of age; Exclusion: 1. Subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method;

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To evaluate the effects of fampridine on eye movements in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO)

Papers

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History

    1. Started

      Jan 2015

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