NCT00986960

Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)

Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.

Detailed description

Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	repository corticotropin injection	IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
DRUG	Saline	I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2009-09-30
• Last updated: 2021-01-05

Locations

1 site across 1 country: United States