A clinical and electrophysiological study of the effects of 4-aminopyridine on upper limb impairment in Multiple Sclerosis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000439741

Enrollment

Registered

2013-04-17

Start date

2013-05-13

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Modified-release fampridine is licensed in Australia for the symptomatic treatment of walking disability in multiple sclerosis (MS). However, many patients with MS have reported beneficial effects on other areas such as fatigue, vision and upper limb function. These benefits have not been formally studied in a trial. In addition, it is not known how modified-release fampridine works and why it seems to work better in some people than others. Electrophysiological techniques such as nerve conduction studies, evoked potentials and transcranial magnetic stimulation can be used to study the nervous system and the effects of drugs on it. These techniques can be used to identify where particular drugs might exert their effect and help to uncover more information about how the drugs work, with the eventual aim of developing new symptomatic treatments for MS. The aim of this study is to use these techniques to examine the nervous system in study participants on and off fampridine and to compare the findings between responders and non-responders to the drug.

Interventions

Temporary withdrawal of modified-release oral fampridine (4-aminopyridine) 10mg twice daily (bd) in patients who are taking the drug, in order for clinical and electrophysiological testing of upper limb function to be carried out and compared on and off the drug. The drug does not require to be weaned prior to withdrawal. Adherence will be monitored by participant self-report.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with multiple sclerosis who are currently taking modified release fampridine 10mg bd and who are willing to stop the drug for at least 10 days in order to permit measurements to be taken and compared on and off drug; preserved cognitive function permitting informed consent for participation.

Exclusion criteria

The following are contraindications to fampridine therapy: history of seizures or epilepsy; hypersensitivity to fampridine; moderate/severe renal impairment; pregnancy; current or recent (60 days) MS relapse; alternative likely cause for upper limb impairment (e.g. peripheral neuropathy, injury); current or recent (60 days) therapy with corticosteroids; current therapy with benzodiazepines; recent (within 60 days) addition of new therapy for multiple sclerosis including disease-modifying therapies and symptomatic therapies.

Outcome results