SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY

Conditions: Multifocal motor neuropathy
MedDRA version: 9.1Level: PTClassification code 10065579Term: Multifocal motor neuropathy

Registration Number: EUCTR2008-005748-18-GB

Lead Sponsor: Greater Glasgow and Clyde NHS Board and The University Of Glasgow

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Fulfilling the diagnostic clinical and electrophysiological entry requirements in Appendix A, as adapted from the European Federation of Neurological Societies (EFNS) and the Peripheral Nerve Society (PNS)*.
2. Able to complete self-evaluation functional rating scale
3. Documented historical responsiveness to IVIg in the opinion of the Investigator
4. Agreement to vaccination against meningococcal infection. (Tetravalent, conjugated vaccination recommended)
5. Is willing and able to give written informed consent.

*Conduction Block (CB) to have been documented at some point in the patient’s history.

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.Below the age of 18 years old.
2.Pregnancy, planned pregnancy or lactation*
3.Inability to comply with study related procedures or appointments.
4.Unresolved Neisseria meningitidis infection.
5.Any condition that in the opinion of the Investigator could increase the patient’s risk by participating in the study or confound the outcome of the study.
6.Hypersensitivity to eculizumab, murine proteins or to any of the excipients
7.Known or suspected hereditary complement deficiencies.

*A serum pregnancy test will be preformed at the first study visit. Trial participants of child-bearing age will be asked to use adequate contraception during the trial and for 5 months after study cessation. Participants will be instructed to inform the PI immediately if they suspect they may be pregnant

The contraindications and special warning regarding meningococcal infection from the Summary of Product Characteristics of eculizumab in its licensed indication, Paroxysmal Nocturnal Haemoglobinuria, are reflected in the inclusion and exclusion criteria of this study.