Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Completed · Phase 3 · Has a placebo group

Conditions studied: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

In brief

The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

Key facts

Study ID

NCT00220740

Run by

Grifols Therapeutics LLC

People needed

117

Starts

2004-04-01

Expected to finish

2006-06-01

Last updated by the study team

2016-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of CIDP must be made by a neurologist specializing/experienced in neuromuscular diseases based on: a) Progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy over the 2 months prior to the date informed consent is obtained, and b) Cerebrospinal fluid (CSF) less than 50 white cells/µl since CIDP diagnosis (CSF testing studies are NOT mandatory)
• Fulfillment of INCAT neurophysiological criteria for focal demyelinating polyradiculoneuropathy
• Overall INCAT score between 2-9 and significant disability in upper or lower limb function in at least 2 limbs. (An INCAT score of 2 must be exclusively from leg disability to qualify.)

You may not qualify if…

• Treatment with IGIV or plasma within 3 months prior to entry
• Steroids (Prednisolone or equivalent) > 10 mg/day or equivalent (i.e., > 20 mg every 2 days) during the last 3 months prior to entry
• Treatment with immunomodulatory/immunosuppressive agents (azathioprin, tacrolimus,cyclosporin, Muromonab-CD3 (OKT3), any interferon), previous lymphoid irradiation or prior treatment with cyclophosphamide, methotrexate, mitoxantrone or any other immunosuppressant drug within the past 6 months prior to entry
• Concomitant use of supplements containing any amount of fish oil within 30 days prior to entry
• Respiratory impairment requiring mechanical ventilation
• Myelopathy or evidence of central demyelination or persisting neurological deficits from stroke, central nervous system (CNS) trauma or peripheral neuropathies of other cause which include diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), uremic, toxic and familial neuropathies
• Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with conduction block. Lower motor neuron disorder with motor weakness in an upper limb, without sensory deficit and with proximal conduction block (50% decrease in amplitude/area with proximal distal stimulation ) in motor nerves and normal sensory nerve conduction studies.
• Clinical or known evidence of associated systemic diseases that might cause neuropathy, including but not limited to connective tissue disease, HIV infection, hepatitis, Lyme disease, cancer (with the exception of benign skin cancer), Castleman's disease and systemic lupus erythematosus, diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), a malignant plasma cell dysplasia, immunoglobulin M (IgM) paraproteinemia, and amiodarone therapy.
• History of anaphylaxis or severe systemic response to immunoglobulin or with a blood product.
• Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or history of congestive heart failure, severe hypertension (diastolic pressure >120 mmHg or systolic >170 mmHg).
• Females who are pregnant, breast feeding, or if of childbearing potential, unwilling to practice adequate contraception throughout the study.
• Known hyperviscosity.
• History of renal insufficiency or serum creatinine levels > 221 µmol/L (2.5 mg/dL).
• Known selective immunoglobulin A (IgA) deficiency.
• Other investigational drugs received within the 30 days prior to entry
• Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
• Known hypercoagulable state.
• Mentally challenged adult subjects who cannot give independent informed consent.
• Subjects with uncompensated hypothyroidism (abnormally high thyroid-stimulating hormone (TSH) and abnormally low T4) or vitamin B12 deficiency (abnormally low) within the last 3 months prior to entry.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Saint Louis University Medical Center — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• Wake Forest University-School of Medicine — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Texas-Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Hospital Ramos Mejia — Buenos Aires, Argentina
• Hospital Frances — Buenos Aires, Argentina
• Fundacion para la Lucha contra Las Enfermedades Neurologicas de la Infacia (FLENI) — Buenos Aires, Argentina
• Instituto de Neurociencias Buenos Aires (INEBA) — Capital Federal, Argentina
• Vancouver Hospital and Health Sciences Center — Vancouver, British Columbia, Canada
• Fakultní nemocnice Brno — Brno, Czechia
• Fakultní nemocnice Ostrava — Ostrava-Poruba, Czechia
• Neurologická klinika Pardubice — Pardubice, Czechia
• Fakultní nemocnice Motol — Prague, Czechia
• Jüdisches Krankenhaus — Berlin, Germany
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Chaim Sheba Medical Center — Tel Litwinsky, Israel
• Assaf Harofe Medical Center — Zrifin, Israel
• Dipartimento di Neuroscienze, Sezione di Neurologia, AO Chieti — Chieti, Italy
• Univesita delgi Studi di Genova, Dipartimento di Scienze, Neurologiche e della Visione — Genova, Italy
• Hospital San Raffaele — Milan, Italy
• Antiguo Hospital Civil de Guadalajara — Guadalajara, Jalisco, Mexico
• Hospital Angel Leano, Neurology Department — Guadalajara, Jalisco, Mexico
• Hospital Central San Luis Potosi, Neurology Department — San Luis Potosí City, Mexico

Full record on ClinicalTrials.gov

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