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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2012-001995-12-GB
Date of registration: 03/06/2013
Prospective Registration: Yes
Primary sponsor: LFB BIOTECHNOLOGIES
Public title: A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy
Scientific title: A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy
Date of first enrolment: 01/08/2013
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001995-12
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: Active comparator
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
France Italy Spain United Kingdom
Contacts
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, ZA de Courtaboeuf BP 40305 91958 Les Ulis Cedex France
Telephone: +33169 82 70 10
Email:
Affiliation:  LFB BIOTECHNOLOGIES
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, ZA de Courtaboeuf BP 40305 91958 Les Ulis Cedex France
Telephone: +33169 82 70 10
Email:
Affiliation:  LFB BIOTECHNOLOGIES
Key inclusion & exclusion criteria
Inclusion criteria:
A patient may be included in the study if all of the following criteria are fulfilled:
1. Male or female patient aged 18 to 80 years.
2. Written informed consent obtained prior to any study-related procedures.
3. Diagnosis of definite or probable MMN according to the EFNS/PNS Guideline 2010, First revision made by neuromuscular disease specialists with specific electrodiagnostic expertise.
4. Patients treated with a stable maintenance dose within 15% of any brand of IVIG (Kiovig excluded) at 1 g/kg for 1-3 days up to 2 g/kg for 2-5 days every 4 to 8 weels (+/-7 days), according to the EFNS/PNS Guideline 2010, First revision for at least 3 months prior to enrolment.
5. Covered by national health care insurance system if required by local regulations.

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion criteria:
A patient may be included in the study if none of the following criteria is met:
1. Upper motor neuron, bulbar, cranial nerve or significant sensory deficit.
2. CSF protein >100 mg/dL (if available and done as part of a previous evaluation).
3. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective diseases, infection with HIV, hepatitis B virus (HBV), or
hepatitis C (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloid, and hereditary neuropathy.
4. BMI = 40 kg/m2.
5. Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig® (glycine).
6. Patients who have been treated with Kiovig® shall not have received Kiovig® during the last 6 months prior to enrolment.
7. History of IgA deficiency, except if the absence of anti-IgA antibodies is documented.
8. Protein-losing enteropathy characterised by serum protein levels <60 g/l and serum albumin levels <30 g/l .
9. History of cardiac insufficiency (New York Heart Association (NYHA)III/IV) , uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
10. History of venous thrombo-embolic disease, myocardial infarction or cerebrovascular accident.
11. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
12. History of kidney transplantation, nephrotic syndrome (defined as
proteinuria >3.5 g per 24 hours accompanied by hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
AND/OR
Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
- glomerular filtration rate (GFR) <60 mL/min/1.73m2 measured
according to the Modified Diet in Renal Disease (MDRD) formula
AND/OR
- urine protein reagent strip: 2 crosses
AND/OR
- urine protein reagent strip: one cross with one of the following:
*albumin excretion rate (AER) >300 mg/24 hours or protein excretion
rate (PER) >500 mg/24 hours (24h-urine collection)
OR
*albumin to creatinine ratio (ACR) >30 mg/mmol or protein to creatinine ratio (PCR) >50 mg/mmol (spot urine sample).
13. Serum levels of AST, or ALT and/or ALP >2 times upper limit of normal range.
14. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-a, interferon-ß 1a, anti-CD20, alemtuzumab, azathioprine, etanercept, mycophenolate mofetil, methotrexate and haematopoietic stem cell transplantation).
15. Administration of another investigational product within the last month prior to inclusion.
16. Plasma exchange, blood products or deri


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multifocal motor neuropathy (MMN)
MedDRA version: 18.0 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: KIOVIG
Product Name: KIOVIG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Current Sponsor code: I10E
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: - Before the course
- During the evaluation period (i.e. 13 weeks after the initiation of either I10E or Kiovig® until the end of the respective treatment period).
Main Objective: The primary objective of this study is to evaluate the efficacy of I10E compared to Kiovig® for maintenance treatment of patients with MMN in a randomised, double-blind, active comparator-controlled, cross-over design.
Primary end point(s): Difference between I10E and Kiovig® in the mean assessments of the original MMRC 10 sum score (10 muscles on both sides see Table 20.1) described by Cats 2008 during the evaluation period (i.e. 13 weeks after the initiation of either I10E or Kiovig® until the end of the respective treatment period).
Secondary Objective: The secondary objective of this study is to assess the safety.
Secondary Outcome(s)

Secondary end point(s): Difference between I10E and Kiovig® in the mean assessments of the following parameters during the evaluation period (i.e. 13 weeks after the initiation of either I10E or Kiovig® until the end of the respective treatment period):
• MMRC 10 new sum score (10 slightly different muscles on both sides chosen because they are expected to be more relevant and responsive to change; see Table 20.1)
• Rasch built MMRC sum score (based on the 10 muscles in the MMRC sum score described by Cats 2008)
• MMRC 14 sum score (14 muscles on both sides)
• Grip strength with dynamometer in the most affected hand
• Need for change of the IVIG dose or frequency due to a worsening of the patient's neurological status with IMPs during the respective treatment period.
• Change of Clinical Global Impression (CGI) during respective treatment periods.
• Discontinuation of study treatment during the respective treatment period.
• INCAT: upper and lower limbs

Timepoint(s) of evaluation of this end point: - Before the course
- During the evaluation period (i.e. 13 weeks after the initiation of either I10E or Kiovig® until the end of the respective treatment period).
Secondary ID(s)
2012-001995-12-IT
I10E-0901
Source(s) of Monetary Support
LFB BIOTECHNOLOGIES
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 03/06/2017
Date Completed: 01/07/2016
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-001995-12/results
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