Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

NCT00418145 | Terminated Phase 3 Results

• 2 other identifiers: GCO 01-0781RG 3363A8
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 10

Brief Summary

This clinical trial compares the relative efficacy of treating acute exacerbations of relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV) methylprednisolone. This is a randomized, blinded, multi-center study.

Conditions

Multiple Sclerosis

Keywords

Relapsing Forms of Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.

  There is no data analysis for this study

  Day 28 and Day 90

Secondary Outcomes (3)

• Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.

  Day 28 and day 90

• Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.

  Day 28 and day 90 and day 365

• Improvement Using Targeted Neurological Deficits (TND).

  Day 28 and day 90

Study Arms (2)

megadose oral methylprednisolone

EXPERIMENTAL

1400 mg qd/5 days

Drug: megadose oral methylprednisolone

IV methylprednisolone

EXPERIMENTAL

1000 mg/qd/5 days

Drug: IV methylprednisolone

Interventions

megadose oral methylprednisolone DRUG

1400 mg qd/5 days

megadose oral methylprednisolone

IV methylprednisolone DRUG

1000 mg/qd/5 days

IV methylprednisolone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 50 years, inclusive.
• Acute symptomatic exacerbation of MS present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
• Diagnosis of a relapsing form of multiple sclerosis before randomization as determined by Poser or McDonald Criteria.
• Expanded disability status scale (EDSS) score between 2 and 6.5, inclusive at entry.
• Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
• New objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. Sensory deficits alone will not qualify except for optic neuritis.
• Subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. Women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
• Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

You may not qualify if:

• Any patients treated with systemic corticosteroid use within one month of the index episode at screening.
• Prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, IVIg) or plasmapheresis.
• Any patient who is pregnant or breastfeeding.
• Unable to perform the Multiple Sclerosis Functional Composite consisting of: Timed 25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test (3 second).
• Peripheral or cranial neuropathy as sole problem of acute episode.
• History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
• Primary Progressive Multiple Sclerosis (PPMS).
• Previous participation in this study.

Sponsors & Collaborators

• Fred Lublin: lead
• National Multiple Sclerosis Society: collaborator
• Pfizer: collaborator

Study Sites (10)

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

The Jacobs Neurological Institute

Buffalo, New York, 14203, United States

Location

Hospital For Joint Diseases

New York, New York, 10003, United States

Location

St. Luke's Roosevelt

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

NY Presbyterian Hospital-Cornell University New York

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of Vermont, Burlington

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Methylprednisolone

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)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The trial was terminated due to difficulties obtaining drug and matching placebo and the inability to meet recruitment. There was no data analysis done for this trial due to low enrollment and data will not be meaningful.

Results Point of Contact

• Title: Dr. Fred Lublin
• Organization: Icahn School of Medicine at Mount Sinai

fred.lublin@mssm.edu

212-241-6854

Study Officials

• Fred Lublin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: September 1, 2003
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Locations

US (10)