Does Fampridine improve fatigue in patients with Multiple Sclerosis.

Fampridine treatment to improve fatigue in Multiple Sclerosis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000799954

Acronym

FAMP-MS

Enrollment

Registered

2011-07-29

Start date

2011-08-15

Completion date

2013-10-31

Last updated

2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose is to investigate whether treatment with the medication, fampridine, can help improve the ability to function in patients who have Multiple Sclerosis. Who is this for? You are eligible to participate in this study if you are ages between 18-80, have Multiple Sclerosis and currently suffer from fatigue and a decreased functional ability. Trial detials In this studywith patients will receiving 12 weeks of Fampridine (active drug) at a dose of 10mg oral tablet twice daily, and 12 weeks of placebo (sham) treatment consisting of lacotse tablets, separated by a 4-week washout period. During the trial, participants will not know if they are receiving active drug or the placebo. Participants will be assessed at basline foloowed by 4 weekly intervals to measure fatigue, functional ability and nerve function.

Interventions

Fampridine- PR Oral tablet, 10mg twice daily for a period of 12 weeks. The study is a double-blind placebo-controlled crossover study, with patients receiving 12 weeks of active drug and 12 weeks of placebo, separated by a 4-week washout period.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Definitive diagnosis of MS 18-80 years of age. Able to provide informed consent.

Exclusion criteria

History of seizures. Current treatment with anticonvulsant medication. Pregnancy or lactation. Contraception is required in pre-menopausal female patients. History of moderate-severe renal impairment. Presence of serious psychiatric disorder (e.g major depression, bipolar disorder) Enrolled in another clinical trial involving an investigational agent. Known allergy to pyridine-containing substances. History of renal dysfunction, with eGFR <60 ml. history of acute relapse within last 60 days EDSS score >6.0

Outcome results