An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

Acorda Therapeutics

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Withdrawal of dalfampridine-ER 10mg

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01535664

AMP-MS-1008

Details and patient eligibility

About

The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

Full description

Longitudinal study design

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of multiple sclerosis
• Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
• No history of seizures except simple febrile seizures

Exclusion criteria

• Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods
• Subject who is pregnant or breastfeeding

Trial design

20 participants in 1 patient group

dalfampridine-ER 10mg

Description:

Subjects with MS taking dalfampridine-ER 10mg and considered to be responders

Treatment:

Other: Withdrawal of dalfampridine-ER 10mg