1009437 / Participant information sheet for eye tracking studies in people with parkinsons
A population based study of genetic predispositions and gene-environment interactions in cancer (Study due to close 30/07/2020)
1204637 / Neurological conditions and oncology: immunology and interactions
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy (Study due to close 01/09/2021)
1310851 / United Kingdom National Registry for Myotonic Dystrophy
United Kingdom National Registry for Myotonic Dystrophy (Study due to close 30/08/2055)
1504080 / ESTEEM
This is a Global Observational Study to better characterize the utilisation and safety profile of the new drug Tecfidera™ for the treatment of patients with Multiple Sclerosis (MS). This observational study will therefore help characterise the effectiveness and safety of Tecfidera™ when prescribed under routine medical care. (Study due to close 01/02/2019)
1702382 / A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone(AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline inSubjects Who Have Completed the AD-4833/TOMM40_301 Study With Diagnosis of MildCognitive Impairment Due to Alzheimer Disease
A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone(AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline in Subjects Who Have Completed the AD-4833/TOMM40_301 Study With Diagnosis of Mild Cognitive Impairment Due to Alzheimer Disease (Study due to close 03/11/2019)
1704402 / A prospective, multicenter, observational, post-authorization safety study to evaluate the long term safety profile of Lemtrada (Alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS)
A prospective, multicenter, observational, post-authorization safety study to evaluate the long term safety profile of Lemtrada (Alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS) (Study due to close 30/07/2018)
1704406 / PFP
One person in every 500 has Parkinson’s and around 127,000 people are living with the condition in the UK. The aim of the study is to identify new genes that predispose or cause Parkinson’s Disease or Parkinsonism. There is a pressing need to study the genetic makeup of family members both with and without Parkinson’s. As families share a common genetic background, it is easier to find new Parkinson’s genes by studying the genetic makeup of people with Parkinson’s alongside other members of their families. We are particularly interested in studying the genetic makeup of two groups of people:
1) those who developed Parkinson’s before the age of 45; and
2) those who have a family history of other relatives affected by Parkinson’s.
By identifying genetic factors that cause Parkinson’s, we hope to understand more about the condition. Doing so will lead to the development of better diagnosis, improved disease models, and we hope in time, to the development of better treatment. (Study due to close 01/03/2027)
1704414 / The DAYBREAK Study
A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK Study) (Study due to close 30/06/2018)
1805636 / A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability
Multiple Sclerosis (MS) is a progressive neurological disorder of the brain and spinal cord. It affects approximately 120,000 people in the UK and 2.5 million people globally. Most people with MS experience two stages of the disease: Early MS – Relapsing-Remitting MS (RRMS), which is partially reversible, and Late MS – Secondary Progressive MS (SPMS), which affects the majority of patients, usually after 10 to 15 years after diagnosis.
SPMS results from progressive neuronal degeneration that causes accumulating and irreversible disability affecting walking, balance, manual function, vision, cognition, pain control, bladder and bowel function. The pathological process driving the accrual of disability in SPMS is not known at present.
Immunomodulatory anti-inflammatory disease modifying therapies (DMTs) are increasingly effective in reducing relapse frequency in RRMS, however, they have been unsuccessful in slowing disease progression in SPMS. This is the overwhelming conclusion from an analysis of 18 phase 3 trials (n=8500), of which 70% of the population had SPMS, all performed in the last 25 years. There is no current disease modifying treatment (DMT) for SPMS.
In an earlier study (MS-STAT1), 140 people with SPMS were randomly assigned to receive either placebo or simvastatin for a period of two years. The investigators found that the rate of brain atrophy (loss of neurons – ‘brain shrinkage’), as measured by magnetic resonance imaging (MRI), was reduced in patients receiving simvastatin compared to those taking placebo.
Several other long term studies have also reported that there might be a relationship between the rate of brain atrophy and the degree of impairment.
The study is designed to test the effectiveness of repurposed simvastatin (80mg) in a phase 3 double blind, randomised, placebo controlled trial (1:1) in patients with secondary progressive MS (SPMS), to determine if the rate of disability progression can be slowed over a 3 year period. (Study due to close 30/06/2023)
1806645 / AFFINITY
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies (Study due to close 31/10/2019)
1808671 / DexEnceph.
Does dexamethasone improve outcomes in adults with HSV Encephalitis? DexEnceph, a Randomised Controlled Study.
Encephalitis means inflammation (swelling) of the brain and in the UK is most often caused by a virus, the Herpes Simplex Virus (HSV). HSV encephalitis is a devastating illness. It affects 1 per 250500,000 people in the UK each year and is classed as a “very rare” disease. Its impact is disproportionately large: 1 in 10 people die, survivors can be left with memory loss, this has huge socioeconomic demands on patients, carers and health services. Verbal memory is especially affected in survivors, this is the ability to remember names of objects and people, and to listen and remember spoken information. Inflammation occurs as part of the body’s response to the infection and, in the fixed space of the skull, can lead to damage. Dexamethasone is a steroid drug that decreases inflammation.
DexEnceph is a trial that aims to find if dexamethasone benefits people with HSV encephalitis.
DexEnceph will recruit 90 adults (age=16) with confirmed HSV encephalitis across UK hospitals over 4 years. Half of the participants will receive dexamethasone and half will not. Those that receive the study drug will receive 10mg of dexamethasone, 4 times a day, for 4 days. All 90 patients will undergo the same assessments over 18 months.
DexEnceph’s main aim is to find if dexamethasone improves verbal memory 6 months after the infection, this is done through neuropsychology testing.
Participants will also have MRI scans, blood and cerebrospinal fluid (CSF, the fluid around the brain and spinal cord) tests, and assessments of disability and quality of life.
We will also collect data from a further 90 participants with symptoms of HSV encephalitis but that go on to have other conditions. This aims to understand the differences in the body’s response in people with symptoms of encephalitis. (Study due to close 28/02/2021)