A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis

Phase 1

• Conditions: Multiple Sclerosis (MS); MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004935-18-BG
• Lead Sponsor: GeNeuro SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-11
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study;
- Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients not having completed study GNC-003.
- Emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient’s neurological signs and symptoms.
- Any major medical or psychiatric disorder that could put the patient at undue risk during the study, according to the investigator’s opinion, or that would affect the capacity of the patient to fulfill the requirements of the study, including: Schizophrenia, bipolar disorder, or major depressive disorder, History of suicide attempt, or current suicidal ideation, current alcohol or drug abuse.
- Body weight<40kg
- Patients not able to follow study instructions, or not able to follow the study assessments defined by the protocol.
- Forbidden concomitant treatments
- Legal incapacity or limited legal capacity.
- Pregnancy.
- Female patients of childbearing potential (FPCBP) or procreative male patients (PMP), not willing to use highly effective contraceptive methods throughout the study duration and at least until 5 months after the last study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified