NCT00306033

Brief Summary

This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
Last Updated

April 3, 2006

Status Verified

May 1, 2005

First QC Date

March 21, 2006

Last Update Submit

March 31, 2006

Conditions

Myasthenia Gravis

Keywords

myasthenia gravisimmunoglobulinintravenous immunoglobulintreatment

Outcome Measures

Primary Outcomes (1)

  • change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity

Secondary Outcomes (1)

  • MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers

Interventions

Intravenous ImmuneGlobulinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness

You may not qualify if:

  • age \<18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Vera Bril, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

March 1, 2004

Study Completion

May 1, 2005

Last Updated

April 3, 2006

Record last verified: 2005-05

Locations

CA(1)