CompletedPhase IIIInterventional

Treatment of autoimmune encephalitis in adults with intravenous immunoglobulin

Autoimmune encephalitis is a serious condition where the body's immune system attacks healthy brain tissue by mistake. This causes swelling in the brain, leading to confusion, memory loss, personality changes, and sometimes seizures. The standard first-line treatment is steroid medication to reduce brain inflammation. Doctors often add intravenous immunoglobulin (IVIG)—a medicine made from donated blood proteins—if a person does not improve after a few weeks. This UK study tests whether giving IVIG right at the start of hospital care helps adults aged 16 and over recover more quickly and prevents long-term disability. All patients receive standard steroid treatment. Half will also receive IVIG through a drip for 5 days, while the other half will receive an inactive dummy drip (placebo). Doctors will track recovery through regular check-ups, memory checks, and questionnaires over several months.

At a glance

Status

Completed

Phase

Phase III

Sponsor

University of Liverpool

Enrolment target

356

Start

11 Nov 2021

Estimated completion

31 Oct 2024

Autoimmune encephalitis

What is this study about?

Autoimmune encephalitis is a rare condition that affects about 1 in 100,000 people in the UK each year. It happens when the body's natural defences mistakenly treat healthy brain tissue as an infection, causing inflammation and swelling. People with this condition can experience sudden confusion, severe memory issues, behavioural changes, and epileptic fits. While some people recover fully, others can be left with long-term disabilities.

The usual treatment starts with high doses of steroid medicine, which works to calm down the immune system and reduce swelling. When steroids do not work quickly enough, doctors often add another medicine called intravenous immunoglobulin, or IVIG. IVIG is made from antibodies collected from healthy blood donors. It is given through a vein and is widely used for several nerve and immune disorders.

Currently, IVIG is typically given only after a patient has failed to improve on steroids alone. Some doctors believe that giving IVIG immediately upon hospital admission could help patients recover faster and reduce permanent brain injury. However, IVIG can cause side effects such as blood clots or allergic reactions, and it is very costly. This Phase III trial aims to find out whether early IVIG truly improves recovery compared to standard steroid treatment alone.

Key takeaways

Tests whether starting IVIG straight away in hospital speeds up recovery from autoimmune encephalitis.
Open to adults aged 16 and over admitted to hospital with recent symptoms of brain swelling.
All patients receive standard steroid treatment; half also get IVIG drips and half get dummy drips.
IVIG is given through a drip for 5 days, followed by recovery check-ups over several months.
Participation is entirely voluntary and patients are closely monitored by hospital specialists.

Who may be eligible?

This trial is open to adults aged 16 and older who have been admitted to hospital with suspected autoimmune encephalitis. Symptoms such as altered alertness, memory problems, personality changes, or unusual behaviours must have lasted for more than 24 hours and have been diagnosed within the last three months. Doctors must also confirm through spinal fluid tests that the swelling is not caused by a viral infection like herpes or chickenpox.

In addition, patients must show other clear signs of the illness, such as new seizures, abnormal brain scans, changes in brainwave tests (EEGs), or specific inflammatory markers in their spinal fluid.

People cannot take part if they have had IVIG within the past six months, if they have medical conditions that make steroids or IVIG unsafe (such as active stomach ulcers), or if another medical condition explains their symptoms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 16 or older?
Have you been admitted to hospital with suspected autoimmune encephalitis?
Did your confusion, memory loss, or behaviour changes start within the last 12 months?
Were your symptoms diagnosed within the last 3 months?
Have viral brain infections been ruled out by spinal fluid tests?
Have you been free from IVIG treatment for at least the past 6 months?

Answer every question to see your result.

What does participation involve?

Participants will begin the trial while admitted to hospital. Everyone receives standard high-dose steroid treatment to reduce brain swelling. Alongside this, patients are randomly chosen by computer to receive either IVIG or a dummy medicine (a placebo) that looks identical. This is given through a drip into a vein once a day for five days. Neither the patient nor their medical team will know which drip is being given.

While in hospital and after returning home, participants will have regular health check-ups. These include routine blood tests, brain scans, simple memory and thinking checks, and questionnaires about daily quality of life and physical recovery.

The trial monitors patients over several months to see how well they recover over time. Taking part involves completing these regular assessments alongside standard NHS hospital care.

Potential risks and benefits

Taking part may not provide direct personal benefit, but participants receive close monitoring from brain specialists throughout their care. If early IVIG proves effective, participants who receive it may recover more quickly. The main risks involve possible side effects from IVIG, such as allergic reactions, headaches, or blood clots, as well as temporary bruising or discomfort from drips and spinal fluid tests (lumbar punctures). Steroids also carry known risks, especially for those who are pregnant. Taking part is completely voluntary, and you can withdraw at any time without your normal NHS care being affected.

Locations (15)

Walton Centre
Approximate
Liverpool, England
University College London
Approximate
London, England
The Royal Liverpool University Hospital
City only
Liverpool, England
Royal Hallamshire Hospital
Approximate
Sheffield, England
John Radcliffe Hopsital
City only
Oxford, England
University Hospital Coventry
Unverified
Coventry, England
Royal Cornwall Hospital
Unverified
Truro, England
Royal Devon and Exeter Hospital
Unverified
Exeter, England
Royal Stoke University Hospital
Unverified
Stoke-on-Trent, England
Addenbrooke's Hospital
Unverified
Cambridge, England
Ashford and St Peter’s Hospital NHS Foundation Trust
Unverified
Ashford, England
Aberdeen Royal Infirmary
Unverified
Aberdeen, Scotland

Common questions

What is IVIG?

IVIG stands for intravenous immunoglobulin. It is a medicine made from natural antibodies collected from healthy blood donors that helps calm an overactive immune system.

Will I definitely receive IVIG in this trial?

No. Half of the participants receive IVIG and the other half receive a harmless dummy drip (placebo), alongside standard steroid medicines.

What is a placebo and why is it used?

A placebo looks just like the real treatment but has no active medicine. It allows doctors to see whether changes in health are truly caused by the IVIG.

Can I still take my other medications?

Yes. All patients will receive standard steroid treatments and any other medicines their hospital doctors feel are necessary for their recovery.

Can I leave the study if I change my mind?

Yes. You or your family can choose to leave the study at any time. Your standard NHS medical care and treatment will not be affected in any way.

How to find out more

Paula Foscarini-Craggs

EncephIG@cardiff.ac.uk +44 (0)29 206 87522 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.