Ongoing Clinical Trials for Multiple System Atrophy
Five clinical trials are currently investigating new treatments for Multiple System Atrophy across Europe. These studies are testing different medications aimed at slowing disease progression and improving quality of life for patients with this rare neurological condition. The trials are taking place in multiple countries including Germany, Spain, France, Italy, Poland, Portugal, Austria, Denmark, the Netherlands, and Czechia.
Clinical trial locations
- Austria
- Czechia
- Denmark
- France
- Germany
- Italy
- Netherlands
- Poland
- Portugal
- Spain
- Study of Amlenetug for Patients with Multiple System Atrophy
- Study of Emrusolmin for Treating Adults with Multiple System Atrophy
- Study on the Safety and Tolerability of Exidavnemab in Patients with Mild to Moderate Parkinson’s Disease
- Study on the Effects of TAK-341 for Patients with Multiple System Atrophy
Study of Amlenetug for Patients with Multiple System Atrophy
This study is investigating Amlenetug, also known as Lu AF82422, a medication given through intravenous infusion. The trial is testing whether this treatment can slow down the progression of the disease over a 72-week period.
Who can participate: Adults between 40 and 75 years old who have been diagnosed with MSA-P (with parkinsonian features) or MSA-C (with cerebellar features) according to 2022 criteria. Participants must have started experiencing movement-related symptoms within the last 5 years and have a life expectancy of more than 3 years. They need a reliable caregiver who can spend at least 3 hours per week with them. The disease must not be too advanced, with a score of 16 or less on the UMSARS Part I assessment (excluding sexual function questions) and a cognitive test score of 22 or higher on the MoCA.
Who cannot participate: People without a confirmed diagnosis of the condition, those outside the specified age range, individuals unable to follow study procedures, those with other medical conditions that might interfere with results, participants already in another clinical trial, pregnant or breastfeeding women, individuals with allergic reactions to the study medication, those with substance abuse history, and people who have had or are planning major surgery during the study period.
What the study involves: Participants will be randomly assigned to receive either Amlenetug or a placebo in a double-blind design, meaning neither participants nor researchers know who receives which treatment. The medication is administered as a 53 mg/ml solution through an IV infusion. The study includes an optional open-label extension where all participants may receive the actual treatment. Regular monitoring includes clinical evaluations, laboratory tests, and imaging studies to measure the treatment’s impact on symptoms and disease progression.
Study of Emrusolmin for Treating Adults with Multiple System Atrophy
This trial is evaluating Emrusolmin, also known as TEV-56286, which is taken orally in capsule form. The study will compare its effects with a placebo over 48 weeks.
Who can participate: Adults aged 30 years or older who have been diagnosed with clinically possible or clinically probable MSA according to the Gilman criteria. Participants must be able to walk at least 10 meters without assistance from another person during screening, though using a walker or cane is allowed.
Who cannot participate: Individuals under 18 years old, those without a confirmed MSA diagnosis, people unable to take medication orally, and individuals who are part of vulnerable populations such as pregnant women or people with certain disabilities.
What the study involves: Participants are randomly assigned to receive either Emrusolmin or placebo in a double-blind design. The study lasts 48 weeks, with regular assessments using the modified Unified Multiple System Atrophy Rating Scale (UMSARS), Clinical Global Impression of Severity (CGI-S), and MSA Quality of Life (MSA-QoL) measures. Safety is monitored through tracking adverse events, vital signs, laboratory tests, and ECG measurements.
Study of psilocybin therapy for psychological distress in patients with COPD, ALS, multiple sclerosis, or atypical Parkinson’s disorders
This study focuses on using psilocybin to treat psychological distress and depression in patients with several progressive conditions, including atypical Parkinson disorders which encompass conditions like Multiple System Atrophy. The study tests different doses of psilocybin capsules (1 mg, 15 mg, and 25 mg) taken by mouth.
Who can participate: Adults aged 18 or older with a confirmed diagnosis of APD (atypical Parkinson disorder) who also have major depressive disorder confirmed through specialized interview and score higher than 19 on the MADRS depression rating scale. Participants must have a life expectancy of at least 6 months, have an identified caregiver or support person, and be able to swallow capsules. For APD patients specifically, they must have advanced to late-stage symptoms with evidence of motor and non-motor fluctuations.
Who cannot participate: Individuals with personal or family history of schizophrenia, psychosis, or bipolar disorder, current severe depression with psychotic features or treatment-resistant depression, suicide attempts in the past year or current suicidal thoughts with plans, active substance abuse in the past 6 months (excluding nicotine), severe heart conditions, uncontrolled high blood pressure, severe liver or kidney problems, pregnancy or breastfeeding, or severe cognitive impairment.
What the study involves: Participants receive two doses of psilocybin capsules during the study, with doses being either 1 mg (low dose) or 15-25 mg (medium/high dose). Depression symptoms are evaluated using the MADRS scale before treatment and six weeks after the second dose. The treatment period lasts approximately two months, with psychological support provided during sessions. The study also measures quality of life, psychological well-being, and the impact on caregivers.
Study on the Safety and Tolerability of Exidavnemab in Patients with Mild to Moderate Parkinson’s Disease
This trial is testing Exidavnemab, a monoclonal antibody given through intravenous infusion, in patients with mild to moderate Parkinson’s Disease. While primarily focused on Parkinson’s Disease, the study is relevant as Parkinson’s symptoms can overlap with atypical Parkinson disorders.
Who can participate: Men and women aged 40 to 85 years with Idiopathic Parkinson’s Disease showing symptoms like slow movement along with either resting tremor or stiffness. Participants must be classified as Stage 1 to 2.5 on the Hoehn and Yahr scale, have no dementia (confirmed by a MoCA score of 22 or higher), and have been on stable Parkinson’s medication for at least 3 months with no dose changes for at least 1 month. They must have a past or current DaT-SPECT or DaT-PET scan showing a dopamine transporter deficit and a positive smell test showing reduced ability to smell. Participants must weigh between 50 kg and 120 kg.
Who cannot participate: Individuals with severe allergic reactions to study medication ingredients, those currently in another clinical trial, people with serious medical conditions like uncontrolled high blood pressure or heart disease, pregnant or breastfeeding women, those with drug or alcohol abuse history within the past year, individuals who had major surgery within the last month, people with HIV, hepatitis B, or hepatitis C infections, and those unable to follow study procedures.
What the study involves: Participants receive either Exidavnemab or placebo through intravenous infusion in multiple doses. Regular monitoring includes vital signs checks, ECGs, and laboratory tests to assess adverse effects. The study focuses on evaluating the safety and tolerability of the medication in patients already on stable Parkinson’s medications.
Study on the Effects of TAK-341 for Patients with Multiple System Atrophy
This trial is investigating TAK-341, a human IgG1 lambda monoclonal antibody against alpha-synuclein, given through intravenous infusion. The study evaluates both effectiveness and safety over 52 weeks.
Who can participate: Adults aged 40 or older (not currently hospitalized) who have a diagnosis of possible or probable MSA, with first symptoms starting within the last 4 years. Participants must have a MoCA score of 18 or higher, a body mass index (BMI) between 18 and 35, and a life expectancy of at least 3 years according to the study doctor’s judgment. They must be able to attend all study appointments and complete all tests, including brain scans and lumbar puncture. Specific scores on UMSARS Part I and Part IV tests are required. Both men and women can participate but must agree to use effective birth control during the study and for a period after the last dose.
Who cannot participate: Individuals without a diagnosis of the condition, those outside the specified age range (typically adults and older adults), and people considered part of vulnerable populations who might be at higher risk of harm or exploitation.
What the study involves: Participants receive either TAK-341 or a placebo as a solution for infusion through intravenous use, administered regularly over 52 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the actual treatment. Regular assessments are conducted to monitor health and treatment effects, including clinical evaluations, laboratory tests, and imaging studies. At the end of the 52-week period, a final evaluation assesses the overall impact of the treatment, measuring changes in symptoms and any side effects experienced.
Summary
The five ongoing clinical trials for Multiple System Atrophy represent a diverse approach to addressing this challenging condition. Three trials focus specifically on MSA, while two others include MSA patients as part of broader studies on related neurological conditions. Most trials are concentrated in Western European countries, with Germany, Spain, France, and Italy hosting multiple studies.
Three distinct approaches are being investigated: monoclonal antibodies targeting alpha-synuclein proteins (Amlenetug and TAK-341), an oral medication with neuroprotective properties (Emrusolmin), and psilocybin therapy for psychological distress. The majority of studies require participants to be in the early to moderate stages of the disease and emphasize the importance of having a reliable caregiver as part of the eligibility criteria.
All trials are designed with rigorous safety monitoring, including regular assessments, laboratory tests, and imaging studies. Study durations range from 48 to 72 weeks, reflecting the chronic nature of the condition and the need for extended observation periods to measure meaningful changes in disease progression.
