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

NCT00986960 | Withdrawn Phase 2 DMC

• 1 other identifier: NDA 08-372
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; relapsing remitting; RRMS

Outcome Measures

Primary Outcomes (1)

• To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS

  Effect of ACTH in MRI

  1 year

Secondary Outcomes (1)

• To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.

  1 year

Study Arms (2)

Adrenocorticotropin hormone

ACTIVE COMPARATOR

Patients receive the hormone

Drug: repository corticotropin injection

Placebo

PLACEBO COMPARATOR

Patients receive placebo only

Drug: Saline

Interventions

repository corticotropin injection DRUG

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

Also known as: H.P. Acthar gel

Adrenocorticotropin hormone

Saline DRUG

I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with MS according to McDonald criteria
• Age 18-65
• Have a RR disease course
• Have EDSS scores 0-5.5
• Have a disease duration \<20 years
• Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
• presence of a documented relapse within the last 12 months
• or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
• Signed informed consent
• Normal kidney functioning (creatinine clearance \>59)

You may not qualify if:

• Presence of relapse or steroid treatment within 60 days prior to study enrollment
• Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
• Presence of optic neuritis within less than 6 months prior to study enrollment
• Diagnosis of osteoporosis (T score ≥2.5 SD)
• Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
• Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
• History of depression while on IFNβ-1a I.M.

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

University at Buffalo, Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Robert Zivadinov, MD, PhD

  Buffalo Neuroimaging Analysis Center

  PRINCIPAL INVESTIGATOR

• Bianca Weinstock-Guttman, MD

  Jacobs Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

US (1)