Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study (ICA-GBS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02029378|
Recruitment Status : Unknown
Verified September 2014 by NHS Greater Glasgow and Clyde.
Recruitment status was: Recruiting
First Posted : January 7, 2014
Last Update Posted : September 23, 2014
Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory' disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients also have double vision or problems with swallowing. GBS mau also involve the respiratory muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period ranging from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies. Progression of weakness in GBS is usually rapid and reaches its peak within 4 weeks in the majority of patients, but many develop their maximum deficit within 2 weeks. Thereafter, the patients have a variable prognosis.
GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days was shown to be effective when administered within the first two weeks after onset of symptoms, and is considered the treatment of choice by most experts in the field. Although the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days), many patients fails to recover abd remain with substantial disability. Patients with GBS and especially those with a poor prognosis potentially may benefit from more powerful abd when possible a more mechanistically rational therapy.
Recent experimental evidence suggests that complement activation palys a crucial role in the development of neuromuscular weakness in GBS making complement inhibitors and regulators attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a complement inhibitor, will be very effective in preventing progression of weakness in patients with GBS.
|Condition or disease||Intervention/treatment||Phase|
|Gullian Barre Syndrome||Drug: Eculizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||March 2016|
Eculizumab, 900 mg intravenously once a week
Placebo Comparator: Placebo
Matched placebo, intravenously once a week
- Determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls [ Time Frame: 6 months ]Primary safety endpoint
- Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks [ Time Frame: 4 weeks ]Primary efficacy endpoint
- Ability to walk unaided (GBS disability score 2) at 8 weeks [ Time Frame: 8 weeks ]
- Time taken to improve by at least one grade (on the GBS disability scale) [ Time Frame: 8 weeks ]
- Time taken to walk independently [ Time Frame: 1 year ]
- Difference in GBS disability score at maximum disability completed with 6 months [ Time Frame: 6 months ]
- Percentage of patients with a clinically relevant improvement in R-ODS score [ Time Frame: 6 months ]An increase from Baseline in R-ODS score by at least 6 points on the centile metric score at 4 weeks and 6 months
- Percentage of patients with a clinically relevant improvement in ONLS [ Time Frame: 6 months ]Defined as an increase from baseline in ONLS score by at least 1 point at 4 weeks and 6 months
- Requirement for ventilatory support (GBS disability score 5) [ Time Frame: 4 weeks ]
- Duration of ventilatory support [ Time Frame: 8 weeks ]
- Occurrence of relapse [ Time Frame: 2 years ]
- Dearth within the first 6 months [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029378
|Contact: Govindsinh Chavadaemail@example.com|
|Contact: Ian Anderson||0141 201 firstname.lastname@example.org|