A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-013841-27-DK
• Date of registration: 27/10/2009
• Prospective Registration: Yes
• Primary sponsor: Baxter Innovations GmbH
• Public title: A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial
• Scientific title: A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial
• Date of first enrolment: 17/12/2009
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013841-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: yes Other trial design description: Stabilization Phase 1 to 3 open, Cross-over Period 1 and 2 double-blind. If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent obtained from the subject prior to any study-related
procedures and study product administration.
2. Diagnosis of definite or probable MMN based on the criteria of the American
Association of Electrodiagnostic Medicine.
Conduction block can be defined by a drop in amplitude. Diagnosis can be based
on chart records
a. Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4
or less or equivalent, at disease onset or appearing prior to screening.
b. No upper motor signs.
c. No bulbar or cranial signs or symptoms.
d. No clinically identifiable sensory abnormalities.
3. Must be on a stable regimen of IGIV for at least 3 months prior to enrollment.
4. Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days).
5. Dose of IGIV to be 0.4 to 2.0 g per kg bodyweight (BW) and infusion cycle.
6. Subjects are adults, male of female, at least 18 years of age.
7. If female and capable of bearing children - have a negative urine pregnancy test
result at enrollment and agree to employ adequate birth control measures for the
duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any clinical or electrophysiological evidence of coexisting neuropathy which may
interfere with outcome assessments, such as diabetic neuropathy, toxic
neuropathy, or neuropathy due to systemic lupus erythematosis.
2. Treatment with other immunosuppressive agents besides IGIV, which have
demonstrated efficacy in MMN such as cyclophosphamide during the 3 months
prior to enrollment (or treatment with Rituximab during the 12 months prior to
enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is
permitted if the dose has been stable for 3 months prior to enrollment.
3. Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous
evaluation).
4. Subjects positive at enrollment for Hepatitis B surface antigen, PCR for HCV,
and/or PCR for HIV Type 1.
5. Subjects with levels of alanine aminotransferase (ALT) or aspartate
aminotransferase (ASP) > 2.5 times the upper limit of normal.
6. Subjects with neutropenia (defined as an absolute neutrophil count [ANC]
<= 1000/mm³)
7. Subjects with serum creatinine levels greater than 1.5 times the upper limit of
normal.
8. Subjects with malignancy other than adequately treated basal cell or squameous
cell carcinoma of the skin or carcinoma in situ of the cervix.
9. Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial
infarction, cerebrovascular accident).
10. Subjects with an ongoing hypersensitivity or persistent reactions (urticaria,
breathing difficulty, severe hypotension, or anaphylaxis) following IGIV.
11. Subjects with immunoglobulin A deficiency and known anti-IgA antibodies.
12. If female, is pregnant or lactating at time of enrollment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multifocal motor neuropathy
MedDRA version: 12.0 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy

Intervention(s)

Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Pharmaceutical Form: Solution for infusion
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with multifocal motor neuropathy (MMN).

Secondary Objective: Evaluation of additional efficacy measures for MMN.
Additional safety analysis and categorization of adverse events.

Primary end point(s): Primary efficacy endpoints:
- Grip strength in the more affected hand.
- Upper limb (Part 6) subsection of the Guy's Neurological Disability Score (GNDS).

Primary safety endpoints include:
- The rate of temporally associated adverse events (AEs) per infusion, defined as the
total number of all AEs that begin during infusion or within 72 hours of completion
of an infusion, irrespective of being related or not related to the study product,
divided by the total number of infusions.
- The proportion of subjects for whom the infusion rate for any infusion was reduced
and/or the infusion was interrupted or stopped for any reason.
- The proportion of subjects reporting one ore more moderate or severe AEs
that begin during infusion or within 72 hours of completion of an infusion.

Secondary ID(s)

160604