The following research trials are currently open to patients with peripheral nerve diseases in the UK.
This list is not yet complete. See also https://clinicaltrials.gov/ which is the international registry of all clinical trials, searchable by disease and country, which also provides further technical information. There is advice to help patients navigate this site HERE
Most clinical trials will pay reasonable travel expenses for patients to attend the hospital. You will have to attend the hospital for monitoring visits which may be quite frequent.
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Disease |
Name of trial |
Intervention |
Inclusion criteria |
Locations |
General information |
Contact |
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CIDP |
Advance-CIDP-1 |
Hyqvia – subcutaneous immunoglobulin with hyaluronidase, which allows faster higher-volume infusion by softening the subcutaneous tissues. Generally it has fewer side effects than IVIG, infusion as fast as IVIG without iv cannulation. There is a 50% chance of getting placebo |
Already on regular IVIG every 2-6 weeks. May be most attractive to patients with adverse effects from IVIG, or poor venous access, or who would like to switch to subcutaneous treatment but are on a high dose (eg average >80g/month) which makes conventional subcutaneous Ig less attractive (due to multiple needles and/or frequent treatment). Exclusion criteria - pure sensory CIDP, IgM paraprotein, MAG Antibodies, diabetic neuropathy or HbA1c>7.5%, immunosuppressive drugs in the past 6 months, prednisolone>10mg/d, or patients without clear therapeutic benefit from IVIG.
|
London (King’s SE5 9RS), Liverpool, Bristol |
This combines many of the advantages of IVIG and subcutaneous immunoglobulin - it is a subcutaneous product which can be infused at the same speed and dosing frequency as IVIG (typically once every 2-4 weeks through a single needle), but avoiding intravenous cannulation, and avoiding the peak-dose adverse effects of IVIG.
The protocol to stop IVIG suddenly, then start either Hyqvia or placebo infusions. If you worsen, you will be assessed, then may go back on IVIG. https://clinicaltrials.gov/ct2/show/NCT02549170 |
Contacts
jonathan.samuel@nhs.net or p.zinzalias@nhs.net 020 3299 7154
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| CIDP | OPTIC |
IVIG (3 weekly) with pulsed methyprednisolone or placebo (3-weekly) for 21 weeks |
New diagnosis CIDP in adults – untreated or if relapse, not-treated for 1 year. |
NHNN and King’s College Hospital, London
(Glasgow, Newcastle Liverpool Oxford Birmingham Cambridge |
This study explores the ability of steroid to give a longer lasting remission to the rapid IVIG improvement seen in 70% of CIDP cases. Withdrawal of the therapy at 6 months will evaluate how long patients remain well when treated with steroid in conjunction with IVIG compared to no steroid.
|
Prof Michael Lunn - 0203 448 8121 |
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CIDP |
CIDP01/CIDP04 |
Phase II study of rozanolixizumab in CIDP
A study to assess the efficacy, safety and tolerability of Rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy |
Patients with stable CIDP treated with IVIG switched to Rozanolixizumab.
The purpose of the study is to evaluate clinical efficacy of Rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
A short term evanuation (CIDP01) with a longer term open lael follow-up (CIDP04) for patients icluded in CIDP01 |
NHNN London Royal Hallamshire Hospital, Sheffield |
Closed to recruitment having achieved its target of 34 patients
A Phase III study is expected |
Prof M Lunn, 0203 448 8121 |
| Anti-MAG paraprteinaemic demyelinating neuropathy (PDPN) | PN1007 (Phase I/IIa study currently suspended) | First in Human Study to Test the Safety and Preliminary Efficacy of PPSGG (PN1007) in Patients With Anti-MAG Neuropathy.
This is a Phase I/IIa, First in Human (FiH), multicenter, single and multiple ascending dose escalation trial of PPSGG (PN-1007), an antibody scavenger of pathogenic anti-MAG immunoglobulin M (IgM) autoantibodies for treatment of anti-MAG neuropathy. The aim of the study is to assess the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PPSGG (PN-1007) in a SAD and a MAD phase in an adaptive trial in anti-MAG neuropathy patients. |
Patients with a confirmed diagnosis of monoclonal IgM associated with MGUS with anti-MAG activity (titre of > 10'000 BTU) and demyelinating neuropathy defined by electrophysiological criteria according to EFNS/PNS PDN guideline, 2010. Clear clinical signs of disability Adequate hepatic and renal function Exclusion Criteria: Patients with total serum IgM levels >30 g. |
NHNN London | This molecule does not treat the underlying haematological disorder (MGUS or low grade lymphoma) but binds up the anti-MAG antibody to remove it from the circulation to reduce the effect on nerves. | Prof Mike Lunn 0203 448 8121 |
| GBS and COVID | BPNS COVID GBS and Vaccine Survey | An audit of UK-wide GBS cases and their relationship to COVID and/or vaccination | All GBS | All UK centres | Clinicians reporting in confidential registry data of cases with dates of GBS, COVID and vaccination to a central database | Prof M Lunn, NHNN |
| GBS | International GBS outcomes study (IGOS) | This study aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. This information will be used to understand the diversity in clinical presentation and response to treatment of GBS. This information will also be used to develop new prognostic models to predict the clinical course and outcome accurately in individual patients with GBS. | Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of GBS, including overlap syndromes, can be included. Inclusion of all males and females of all ages, independent of disease severity and treatment Inclusion within two weeks of onset of weakness Inclusion of patients transferred from another hospital if the stay in the first hospital was less than one week Opportunity to conduct a follow-up of at least one year Informed consent of patient or, in case of children, of parents or legal guardians |
Various UK Centres | Open to recruitment - currently nearly 2000 recruited, may close in 2021 |
Dr B C Jacobs, Erasmus Medical Center, Rotterdam, The Netherlands, UK lead - Hugh Willison, Glasgow |
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UK Chief Investigator James Holt, Liverpool.
Contacts jonathan.samuel@nhs.net or p.zinzalias@nhs.net 020 3299 7154 |
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