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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: 26 February 2018
Main ID:  EUCTR2012-001995-12-IT
Date of registration: 13/03/2013
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: 19/05/2015
Target sample size: 20
Recruitment status: Authorised-recruitment may be ongoing or finished
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:  ZA de Courtaboeuf, 3, avenue des Tropiques 91940 Les Ulis Cedex France
Telephone: +33169 82 70 10
Email:
Affiliation:  LFB BIOTECHNOLOGIES
Name: Clinical trial information desk   
Address:  ZA de Courtaboeuf, 3, avenue des Tropiques 91940 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 (without any change in doses > or < 15% ) of any brand of IVIG (Kiovig excluded) at 1 g/kg body weight every 4-week intervals up to 2 g/kg body weight every 4-week to 8-week intervals 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 disease that may cause neuropathy or may interfere with outcome assessments, such as diabetes, vasculitis, or systemic lupus erythematosus.

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. History of Kiovig® use.

7. History of IgA deficiency, except if the absence of anti-IgA antibodies is documented.

8. Patient infected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

9. Protein-losing enteropathy characterised by serum protein levels <60 g/l and serum albumin levels <30 g/l or nephrotic syndrome characterised by proteinuria =3.5 g /24 hours, serum protein levels <60 g/l and serum albumin levels <30 g/l.

10. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV) or uncontrolled severe hypertension.

11. History of thrombotic episodes (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident).

12. Glomerular filtration rate <80 ml/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) calculation.

13. Serum levels of AST, ALT and/or ALP >2 times upper limit of normal range.

14. Patient treated with immunomodulator/immunosuppressor (e.g. cyclophosphamide, cyclosporine or interferon), except use at the same dose of: methotrexate, mycophenolate mofetil, or azathioprine for at least 6 months before the inclusion visit.

15. Treatment with an anti-CD20 antibody within the 12 previous months.

16. Administration of another investigational product within the last month prior to inclusion.

17. Exposure to blood products or derivatives other than commercial IgG, within 3 months prior to inclusion.

18. Positive results of pregnancy blood test or breast-feeding woman, or woman of childbearing potential without effective contraception for the duration of the study.

19. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient from complying with the protocol requirements.

20. Anticipated poor compliance of patient with study procedures during the 12 month duration of the study.

21. Drug or alcohol abuse.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multifocal motor neuropathy (MMN)
MedDRA version: 15.1 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)
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 original MMRC 10 sum score (10 muscles on both sides see Table 20.1) described by Cats 2008
Secondary Objective: The secondary objective of this study is to assess the safety.
Timepoint(s) of evaluation of this end point: - Before the course

- Efficacy assessments between 13 and 25 weeks for each period and depending on courses frequencies

- End of study visit
Secondary Outcome(s)
Secondary end point(s): Difference between I10E and Kiovig® in:
• 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.
• Change of Clinical Global Impression (CGI)
• Discontinuation of study treatment
• INCAT: upper and lower limbs
Timepoint(s) of evaluation of this end point: - Before the course

- End of study visit

- For INCAT: assessments between 13 and 25 weeks for each period and depending on courses frequencies

- For Grip strength: 2 weeks (15-18 days) after the last course of each period
Secondary ID(s)
I10E-0901
Source(s) of Monetary Support
LFB BIOTECHNOLOGIES
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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