- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685265
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease
March 20, 2023 updated by: MODAG GmbH
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food of anle138b in Mild to Moderate Parkinson's Disease
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered anle138b as well as the effect of food and early signs of efficacy in patients with mild to moderate Parkinson´s disease.
Study Overview
Detailed Description
This is a two centre, double-blind, randomised, placebo-controlled, multiple ascending dose study in patients with mild to moderate Parkinson´s disease.
It is planned to enrol up to 5 cohorts.
Cohorts A-C consist of up to 8 subjects.
In Cohorts A and B, subjects will be randomly assigned to receive multiple ascending oral doses of anle138b or matching placebo (6 active investigational medicinal product [IMP], 2 placebo per cohort in cohorts A-C) for 7 days in a sequential escalating manner.
Subjects in cohort A and B will be dosed once dialy and subjects in cohort C will be dosed twice a day.
Subjects in Cohorts A and B will also receive an additional single oral dose of active IMP or matching placebo on Day 9 of the study for an assessment of the effect of food on the PK of anle138b in PD patients.
Subjects in cohort D will be randomly assigned to receive QD doses of anle138b or matching placebo (placebo vs 150 mg vs 300 mg; 1:1:1) for 7 days in fasted state.
Subjects in Cohort E will be randomly assigned to receive QD doses of either 300 mg anle138b or matching placebo (1:1) for 28 days taken in the non-fasted state.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nottingham, United Kingdom, NG11 6JS
- Quotient Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females with a diagnosis of idiopathic PD as defined by the Movement Disorders Society criteria (either fulfilling criteria for "Clinically Established PD" or for "Clinically Probable PD").
- Body mass index (BMI) 18.5 to 35.0 kg/m2 or 18.5 to <40.0 kg/m2 (Cohorts D and E) as measured at screening.
- Hoehn and Yahr stage I-III (able to walk unaided).
- Stable medication for PD for 1 month prior to screening at Quotient and anticipated over the study period.
- No history of dementia.
- Must be willing and able to communicate and participate in the whole study.
- Must provide written informed consent.
- Must agree to adhere to the contraception requirements defined in the study protocol.
Exclusion Criteria:
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
- Subjects who are, or are immediate family members of, a study site or sponsor employee.
- Evidence of current SARS-CoV-2 infection.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- A confirmed positive alcohol breath test at screening or admission.
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission (Cohorts A to C only).
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months (Cohorts A to C only).
- Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum or urine pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 IU/L).
- Male subjects with pregnant or lactating partners.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
- Clinically significant abnormal coagulation (Cohort E only), clinical chemistry, haematology or urinalysis as judged by the investigator.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease or psychiatric disorder, as judged by the investigator.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies other than their regular medication according to the referral letter from NUH, and/or up to 2 g of paracetamol per day and/or HRT, in the 14 days before IMP administration.
- Subjects who are taking, or have taken, in the 14 days before IMP administration the drug warfarin.
- Subjects who are taking, or have taken, in the 14 days before IMP administration any drug that is considered to interfere with the objectives of the study, as determined by the concomitant medication oversight committee.
- Subjects who have participated in Cohorts A to C of this study will not be allowed to participate in Cohorts D or E, and subjects who have participated in Cohort D will not be allowed to participate in Cohort E.
- Failure to satisfy the investigator of fitness to participate for any other reason.
- Subjects who have a new headache with features suggestive of raised intracranial pressure, including papilloedema, vomiting, posture-related headache, or headache on waking from sleep (Cohort E only).
- Subjects who have a new headache with focal neurological symptoms, or non-focal neurological symptoms such as change in personality or memory, or an unexplained headache that becomes progressively severe, or an unexplained headache in anyone previously diagnosed with cancer (Cohort E only).
- Medical history or evidence of mass occupying lesion in brain or spinal cord or history of spinal cord injury, which could preclude the procedure of lumbar puncture and CSF collection (Cohort E only).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: anle138b
150 mg and higher dosage
|
capsule containing excipient and anle138b
|
Placebo Comparator: Placebo
Matching placebo dosage
|
matching placebo capsule containing excipient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 14-16: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Adverse events
|
Day 1 to day 14-16: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing (day 9) to day 12-14
|
Adverse events
|
From fed dosing (day 9) to day 12-14
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Blood pressure
|
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Heart rate
|
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Oral temperature
|
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 1 week post dosing
|
Blood pressure
|
From fed dosing to 1 week post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 1 week post dosing
|
Heart rate
|
From fed dosing to 1 week post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 1 week post dosing
|
Oral temperature
|
From fed dosing to 1 week post dosing
|
Incidence of treatment-emergent ECG changes in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)
|
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent ECG changes in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 1 week post dosing
|
Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)
|
From fed dosing to 1 week post dosing
|
Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Physical examination findings
|
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D
|
Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 1 week post dosing
|
Physical examination findings
|
From fed dosing to 1 week post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 8
|
Clinical laboratory Tests: Hematology
|
Day 1 to day 8
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 8
|
Clinical chemistry: Renal function tests
|
Day 1 to day 8
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 8
|
Clinical chemistry: Hepatic enzymes
|
Day 1 to day 8
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 8
|
Clinical chemistry: Electrolytes
|
Day 1 to day 8
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 8
|
Clinical chemistry: Creatine kinase
|
Day 1 to day 8
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 24 hours post dosing
|
Clinical laboratory Tests: Hematology
|
From fed dosing to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 24 hours post dosing
|
Clinical chemistry: Renal function tests
|
From fed dosing to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 24 hours post dosing
|
Clinical chemistry: Hepatic enzymes
|
From fed dosing to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 24 hours post dosing
|
Clinical chemistry: Electrolytes
|
From fed dosing to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
Time Frame: From fed dosing to 24 hours post dosing
|
Clinical chemistry: Creatine kinase
|
From fed dosing to 24 hours post dosing
|
Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Adverse events
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Blood pressure
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Heart rate
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Oral temperature
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to week 6 post dosing
|
Physical examination findings
|
Day 1 to week 6 post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to 24 hours post dosing
|
Clinical laboratory Tests: Hematology
|
Day 1 to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to 24 hours post dosing
|
Clinical chemistry: Renal function tests
|
Day 1 to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to 24 hours post dosing
|
Clinical chemistry: Hepatic enzymes
|
Day 1 to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to 24 hours post dosing
|
Clinical chemistry: Electrolytes
|
Day 1 to 24 hours post dosing
|
Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Time Frame: Day 1 to 24 hours post dosing
|
Clinical chemistry: Creatine kinase
|
Day 1 to 24 hours post dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Tlag for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Tmax for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Cmax for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohort B).
Time Frame: Day 1 to day 9
|
PK parameter: C12 for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: C24 for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: AUC(0-tau) for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Lambda-z for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: T1/2 for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Accumulation ratio for Cmax (Day 7) for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Time Frame: Day 1 to day 9
|
PK parameter: Accumulation ratio for AUC (Day 7) for anle138b.
|
Day 1 to day 9
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 48 hours post dosing.
|
PK parameter: Cmax for anle138b.
|
From fed dosing to 48 hours post dosing.
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fed state (Cohorts A and B).
Time Frame: From fed dosing to 48 hours post dosing.
|
PK parameter: AUC(0-24) for anle138b.
|
From fed dosing to 48 hours post dosing.
|
Effect of multiple ascending doses of anle138b on the motor status of PD patients
Time Frame: Admission to follow-up visit (days 14-16 for cohorts A and B; days 12-14 for cohort C; week 6 for cohorts D and E)
|
Changes from baseline in the "Movement Disorder Society-sponsored revision of the Unified PD Rating Scale" (MDS-UPDRS) ranging from 0 to 260 points with less points meaning less severity.
|
Admission to follow-up visit (days 14-16 for cohorts A and B; days 12-14 for cohort C; week 6 for cohorts D and E)
|
Effect of multiple doses of anle138b on the CSF levels of anle138b in PD patients
Time Frame: single time point 3 hours post dose on dosing day 5 (cohort B)
|
Quantification of anle138b
|
single time point 3 hours post dose on dosing day 5 (cohort B)
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Tlag for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Tmax for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Cmax for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: C12 for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: C24 for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: AUC(0-tau) for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Lambda-z for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: T1/2 for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Accumulation ratio for Cmax for anle138b
|
Day 1 to day 30
|
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the non-fasted state (cohort E)
Time Frame: Day 1 to day 30
|
PK parameter: Accumulation ratio for AUC for anle138b
|
Day 1 to day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nand Singh, BSc, MD, DPM, MFPM, Quotient Sciences Mere Way Ruddington Fields Ruddington Nottingham NG11 6JS, UK
- Principal Investigator: Jonathan Evans, MD, Nottingham University Hospitals NHS Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wagner J, Ryazanov S, Leonov A, Levin J, Shi S, Schmidt F, Prix C, Pan-Montojo F, Bertsch U, Mitteregger-Kretzschmar G, Geissen M, Eiden M, Leidel F, Hirschberger T, Deeg AA, Krauth JJ, Zinth W, Tavan P, Pilger J, Zweckstetter M, Frank T, Bahr M, Weishaupt JH, Uhr M, Urlaub H, Teichmann U, Samwer M, Botzel K, Groschup M, Kretzschmar H, Griesinger C, Giese A. Anle138b: a novel oligomer modulator for disease-modifying therapy of neurodegenerative diseases such as prion and Parkinson's disease. Acta Neuropathol. 2013 Jun;125(6):795-813. doi: 10.1007/s00401-013-1114-9. Epub 2013 Apr 19.
- Levin J, Schmidt F, Boehm C, Prix C, Botzel K, Ryazanov S, Leonov A, Griesinger C, Giese A. The oligomer modulator anle138b inhibits disease progression in a Parkinson mouse model even with treatment started after disease onset. Acta Neuropathol. 2014 May;127(5):779-80. doi: 10.1007/s00401-014-1265-3. Epub 2014 Mar 11. No abstract available.
- Heras-Garvin A, Weckbecker D, Ryazanov S, Leonov A, Griesinger C, Giese A, Wenning GK, Stefanova N. Anle138b modulates alpha-synuclein oligomerization and prevents motor decline and neurodegeneration in a mouse model of multiple system atrophy. Mov Disord. 2019 Feb;34(2):255-263. doi: 10.1002/mds.27562. Epub 2018 Nov 19.
- Wegrzynowicz M, Bar-On D, Calo' L, Anichtchik O, Iovino M, Xia J, Ryazanov S, Leonov A, Giese A, Dalley JW, Griesinger C, Ashery U, Spillantini MG. Depopulation of dense alpha-synuclein aggregates is associated with rescue of dopamine neuron dysfunction and death in a new Parkinson's disease model. Acta Neuropathol. 2019 Oct;138(4):575-595. doi: 10.1007/s00401-019-02023-x. Epub 2019 May 31.
- Wagner J, Krauss S, Shi S, Ryazanov S, Steffen J, Miklitz C, Leonov A, Kleinknecht A, Goricke B, Weishaupt JH, Weckbecker D, Reiner AM, Zinth W, Levin J, Ehninger D, Remy S, Kretzschmar HA, Griesinger C, Giese A, Fuhrmann M. Reducing tau aggregates with anle138b delays disease progression in a mouse model of tauopathies. Acta Neuropathol. 2015 Nov;130(5):619-31. doi: 10.1007/s00401-015-1483-3. Epub 2015 Oct 6.
- Martinez Hernandez A, Urbanke H, Gillman AL, Lee J, Ryazanov S, Agbemenyah HY, Benito E, Jain G, Kaurani L, Grigorian G, Leonov A, Rezaei-Ghaleh N, Wilken P, Arce FT, Wagner J, Fuhrmann M, Caruana M, Camilleri A, Vassallo N, Zweckstetter M, Benz R, Giese A, Schneider A, Korte M, Lal R, Griesinger C, Eichele G, Fischer A. The diphenylpyrazole compound anle138b blocks Abeta channels and rescues disease phenotypes in a mouse model for amyloid pathology. EMBO Mol Med. 2018 Jan;10(1):32-47. doi: 10.15252/emmm.201707825.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2020
Primary Completion (Actual)
November 7, 2022
Study Completion (Actual)
December 22, 2022
Study Registration Dates
First Submitted
December 17, 2020
First Submitted That Met QC Criteria
December 22, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- anle138b-P1-02
- 2020-004869-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
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ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
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King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
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Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
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National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
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Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
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Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
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Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
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Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
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University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on anle138b
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MODAG GmbHQuotient Sciences; Aptuit (Verona) Srl, an Evotec CompanyCompletedHealthy VolunteersUnited Kingdom
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Assiut UniversityCompletedHeavy Menstrual Bleeding | Improve Quality of LifeEgypt
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MODAG GmbHTeva Pharmaceutical Industries, Ltd.; Quotient Sciences; AptuitCompletedHealthy VolunteersUnited Kingdom