Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3NCT00004772
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
A Phase 3 study testing Immune globulin in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- What is being tested?
- Immune globulin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 1992to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Chronic inflammatory demyelinating polyneuropathy (CIDP), i.e.: Progressive or relapsing motor and sensory dysfunction of more than 1 limb over at least 2 months Hypo- or areflexia of at least 2 limbs No myelopathy No central demyelination No drug or toxic exposure known to cause peripheral neuropathy --Prior/Concurrent Therapy-- No prior corticosteroids or other immunomodulators for CIDP No prior plasmapheresis At least 30 days since participation in other investigational study At least 6 months since the following: Cyclophosphamide Intravenous immune globulin Cyclosporine Interferon alfa Azathioprine Corticosteroids Orthoclone Tacrolimus --Patient Characteristics-- Hepatic: No hepatitis Renal: Not specified Neurologic: Cerebrospinal fluid (CSF) protein greater than 50 mg/dL CSF cell count less than 10 CSF VDRL negative 3 of the following motor abnormalities by electrophysiology: Reduced conduction velocity in 2 or more motor nerves Less than 80% of normal if amplitude greater than 80% of normal Less than 70% of normal if amplitude less than 80% of normal Conduction block or abnormal temporal dispersion in 1 motor nerve No ulnar or peroneal nerve entrapment Prolonged distal latency in 2 or more nerves Greater than 125% of normal if amplitude greater than 80% of normal Greater than 150% of normal if amplitude less than 80% of normal Absent F-waves or H response (patients aged under 60) or prolonged shortest F-wave latency in 10 to 15 trials in 2 or more motor nerves Other: No hypersensitivity to immune globulin No IgA deficiency No mutilation of hands or feet No retinitis pigmentosa No ichthyosis No disease that would limit neuromuscular assessment No endocrinopathy No connective tissue disease or vasculitis No Lyme disease No malignancy No Castleman's disease No hyper- or hypothyroidism No HIV infection No alcohol or drug abuse No pregnant or nursing women
About this study
OBJECTIVES:
- Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. The first group receives intravenous immune globulin (IVIG) on days 1, 2, and 21; the second group receives an intravenous placebo on the same schedule.
Patients in either group may receive IVIG (same dosage as first group) after day 42.
Concurrent steroids and other immune globulin preparations are prohibited.
- Being tested
- Immune globulin
- Keywords
- demyelinating neuropathy, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune globulinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ohio State University
- Investigators
- Jerry R. Mendell, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004772
- Sponsor's protocol ID
- 199/11794
- Other IDs
- OSU-92H0250
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
- ClinicalTrials.gov ID
- NCT00004772
- Acronym / sponsor ID
- 199/11794
- Keywords
- demyelinating neuropathy, neurologic and psychiatric disorders, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Ohio State University
- Study start
- Sep 1992
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. The first group receives intravenous immune globulin (IVIG) on days 1, 2, and 21; the second group receives an intravenous placebo on the same schedule.
Patients in either group may receive IVIG (same dosage as first group) after day 42.
Concurrent steroids and other immune globulin preparations are prohibited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune globulin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry R. Mendell study chair
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immune globulin in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.