Back to resultsSafety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease
Primary Purpose
Huntington Disease
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
intra-striatal rAAV5-miHTT
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring Gene therapy, AAV (adeno-associated virus), serotype 5 AAV (adeno-associated virus), serotype 5, Viral vector, miHTT, muHTT, Huntington's Disease (HD)
Eligibility Criteria
Inclusion Criteria:
- Early manifest HD as defined by a UHDRS total functional capacity (TFC) score of 9 to 13 and EITHER a diagnostic classification level (DCL) of 4 OR a DCL of 3 if the subject either meets the definition of multidimensional manifest HD (UHDRS question 80) or DSM5
- HTT gene expansion testing with the presence of ≥40 CAG repeats.
- Striatal MRI volume requirements per hemisphere: Putamen ≥2.5 cm3 (per side); Caudate ≥2.0 cm3 (per side)
- All HD concomitant medications (addressing motor, behavioral, and cognitive symptoms) stable for 3 months prior to Screening.
- Able and willing to provide written informed consent
- Able and willing to comply with all procedures and study visits
Exclusion Criteria:
- Evidence of suicide risk
- Receipt of an experimental agent within 60 days or five half-lives prior to Screening or anytime over the duration of this study.
- Participation in an investigational trial or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc.) within 60 days prior to Screening or anytime over the duration of this study.
- Presence of an implanted deep brain stimulation device, ventriculoperitoneal or other CSF shunt, or other implanted catheter
- Any history of gene therapy, RNA or DNA targeted HD specific investigational agents, such as antisense oligonucleotides (ASO), cell transplantation or any other experimental brain surgery.
- Any contraindication to lumbar puncture or 3.0 Tesla MRI as per local guidelines.
- Brain and spinal pathology that may interfere with the surgical delivery of AMT-130 or represents a significant neurologic comorbid disorder.
- Malignancy within 5 years of screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks of Screening or planned during the study.
- Current or recurrent disease, infection, or other significant concurrent medical condition or medications that could confound clinical and laboratory evaluations or could affect a subject's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule
Sites / Locations
- Universitaetsklinikum Düsseldorf
- George Huntington Institute
- Interventional Neuro Center
- Instytut Psychiatrii i NeurologiiRecruiting
- Cardiff UniversityRecruiting
- National Hospital for Neurology & NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 (Low Dose of AMT-130)
Cohort 2 (High Dose of AMT-130)
Arm Description
Low dose AMT-130 (6 × 10^12 gc/subject)
High dose AMT-130 (6 × 10^13 gc/subject)
Outcomes
Primary Outcome Measures
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Adverse Events
Evaluation will be assessed by;
- Type and incidence of Adverse Events (AEs)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Blood Pressure
Evaluation will be assessed by;
- Changes from baseline in blood pressure (mmHg)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Respiratory Rate
Evaluation will be assessed by;
- Changes from baseline in respiratory rate (BPM)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Heart Rate
Evaluation will be assessed by;
- Changes from baseline in heart rate (BPM)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Electrocardiograms
Evaluation will be assessed by;
- Changes from baseline in electrocardiograms (ECGs) for any clinically significant abnormalities or clinically significant worsening. (normal or abnormal)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by changes documented in the neurological examinations
Evaluation will be assessed by;
- Changes from baseline in neurological examinations including mental status, cranial nerves, sensory, motor, fine motor, reflexes, and gait (normal or abnormal)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by changes documented in the physical examinations
Evaluation will be assessed by;
- Changes from baseline in physical examinations assessed by physical appearance, HEENT, Neck, Chest and Lungs, Cardiovascular, Abdomen, Musculoskeletal, and Genitourinary (normal or abnormal)
Evaluate the safety and tolerability by number of participants with clinically significant changes in laboratory tests - Clinical Chemistry
Evaluation will be assessed by;
- Changes from baseline in Clinical Chemistry laboratory tests with clinical significance.
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with clinically significant laboratory tests - hematology
Evaluation will be assessed by;
- Changes from baseline in hematology laboratory tests with clinical significance.
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with clinical significant laboratory tests - urinalysis
Evaluation will be assessed by;
- Change from baseline in routine urinalysis test with clinical significance.
Evaluate the safety and tolerability o by number of participants with clinical significant changes in cerebrospinal fluid (CSF) analysis
Evaluation will be assessed by;
- Change from baseline in CSF analysis with clinical significance.
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by vector shedding
Evaluation will be assessed by;
- Change over time in AAV5 vector shedding
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Evaluation will be assessed by;
- Change over time in microglial activation (YKL-40) (pg/mL)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Evaluation will be assessed by;
- Change over time in antibodies against AAV5 (g/L)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Evaluation will be assessed by;
- Change over time in cytokines (pg/mL)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Evaluation will be assessed by;
- Change over time in ELISpot
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Evaluation will be assessed by;
- Change over time in astroglial activation (GFAP) (pg/mL)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by cognitive assessment
Evaluation will be assessed by;
- Change from baseline to Day 14 and Month 1 in the Montreal Cognitive Assessment (MoCA)
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with changes in MRI
Evaluation will be assessed by;
- Change from baseline will be measured by edema, inflammation, volume loss, and structural changes as measured by the following MRI pulse sequences, T1, T2 and diffusion MRI (dMRI)
Secondary Outcome Measures
Duration of persistence of AMT-130 in the brain
Change over time in levels of AMT-130-derived Vector DNA and miRNA Expression in the Cerebrospinal Fluid (CSF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05243017
Brief Title
Safety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease
Official Title
A Phase Ib/II Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT 130) in Early Manifest Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
October 7, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UniQure Biopharma B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is the second study of AMT-130 in patients with early manifest HD and is designed as part of an integrated two-study phase I/II program under a single data safety monitoring board (DSMB) with staggered enrollment based upon continued demonstration of safety of AMT-130 administration.
Detailed Description
The aim of the European study is to build upon the safety demonstrated in the first human dose (FHD) randomized, double blind, sham-controlled sequential dose escalation study (CT-AMT-130-01; clinicaltrials.gov NCT04120493) being conducted in the US and expand the number of patients exposed to the two doses to provide sufficient sample size for comparisons of safety and efficacy. CT-AMT-130-02 is a Phase Ib/II open-label sequential ascending dose study that will be conducted in approximately 5 to 8 European HD centers; 3 to 4 of these centers will serve as surgical sites. Both studies will share a common set of clinical, safety, imaging, and biomarker evaluations over 5 years of follow-up. The DSMB will evaluate safety and other parameters to enable the staggered treatment of patients within each of the dosing cohorts
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Gene therapy, AAV (adeno-associated virus), serotype 5 AAV (adeno-associated virus), serotype 5, Viral vector, miHTT, muHTT, Huntington's Disease (HD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The first cohort will be treated with low dose, and a total of 6 enrolled participants is anticipated. The second cohort will be treated with high dose, and a total of 9 enrolled participants is anticipated.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (Low Dose of AMT-130)
Arm Type
Experimental
Arm Description
Low dose AMT-130 (6 × 10^12 gc/subject)
Arm Title
Cohort 2 (High Dose of AMT-130)
Arm Type
Experimental
Arm Description
High dose AMT-130 (6 × 10^13 gc/subject)
Intervention Type
Genetic
Intervention Name(s)
intra-striatal rAAV5-miHTT
Other Intervention Name(s)
AMT-130
Intervention Description
One time MRI-guided stereotaxic infusion of rAAV5-miHTT into the brain
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Adverse Events
Description
Evaluation will be assessed by;
- Type and incidence of Adverse Events (AEs)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Blood Pressure
Description
Evaluation will be assessed by;
- Changes from baseline in blood pressure (mmHg)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Respiratory Rate
Description
Evaluation will be assessed by;
- Changes from baseline in respiratory rate (BPM)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Vital Signs - Heart Rate
Description
Evaluation will be assessed by;
- Changes from baseline in heart rate (BPM)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by Electrocardiograms
Description
Evaluation will be assessed by;
- Changes from baseline in electrocardiograms (ECGs) for any clinically significant abnormalities or clinically significant worsening. (normal or abnormal)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by changes documented in the neurological examinations
Description
Evaluation will be assessed by;
- Changes from baseline in neurological examinations including mental status, cranial nerves, sensory, motor, fine motor, reflexes, and gait (normal or abnormal)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by changes documented in the physical examinations
Description
Evaluation will be assessed by;
- Changes from baseline in physical examinations assessed by physical appearance, HEENT, Neck, Chest and Lungs, Cardiovascular, Abdomen, Musculoskeletal, and Genitourinary (normal or abnormal)
Time Frame
6 months
Title
Evaluate the safety and tolerability by number of participants with clinically significant changes in laboratory tests - Clinical Chemistry
Description
Evaluation will be assessed by;
- Changes from baseline in Clinical Chemistry laboratory tests with clinical significance.
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with clinically significant laboratory tests - hematology
Description
Evaluation will be assessed by;
- Changes from baseline in hematology laboratory tests with clinical significance.
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with clinical significant laboratory tests - urinalysis
Description
Evaluation will be assessed by;
- Change from baseline in routine urinalysis test with clinical significance.
Time Frame
6 months
Title
Evaluate the safety and tolerability o by number of participants with clinical significant changes in cerebrospinal fluid (CSF) analysis
Description
Evaluation will be assessed by;
- Change from baseline in CSF analysis with clinical significance.
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by vector shedding
Description
Evaluation will be assessed by;
- Change over time in AAV5 vector shedding
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Description
Evaluation will be assessed by;
- Change over time in microglial activation (YKL-40) (pg/mL)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Description
Evaluation will be assessed by;
- Change over time in antibodies against AAV5 (g/L)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Description
Evaluation will be assessed by;
- Change over time in cytokines (pg/mL)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Description
Evaluation will be assessed by;
- Change over time in ELISpot
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by laboratory testing serum and CSF for biomarkers
Description
Evaluation will be assessed by;
- Change over time in astroglial activation (GFAP) (pg/mL)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by cognitive assessment
Description
Evaluation will be assessed by;
- Change from baseline to Day 14 and Month 1 in the Montreal Cognitive Assessment (MoCA)
Time Frame
6 months
Title
Evaluate the safety and tolerability of bilateral striatal delivery of AMT-130 as a total HTT gene lowering therapy in adult subjects with early manifest HD assessed by number of participants with changes in MRI
Description
Evaluation will be assessed by;
- Change from baseline will be measured by edema, inflammation, volume loss, and structural changes as measured by the following MRI pulse sequences, T1, T2 and diffusion MRI (dMRI)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duration of persistence of AMT-130 in the brain
Description
Change over time in levels of AMT-130-derived Vector DNA and miRNA Expression in the Cerebrospinal Fluid (CSF)
Time Frame
Collected for duration of study through month 60
Other Pre-specified Outcome Measures:
Title
CSF Mutant Protein (fM)
Description
Will be used as an exploratory biomarker to measure disease progression and responsiveness to AMT-130 treatment.
Time Frame
Collected for duration of study through month 60
Title
CSF/Serum Neurofilament Light Chain (pg/mL)
Description
Will be used as an exploratory biomarker to measure disease progression and responsiveness to AMT-130 treatment.
Time Frame
Collected for duration of study through month 60
Title
Mean changes from baseline in summary scores for the Unified Huntington Disease Rating Scale (UHDRS)
Description
The UHDRS will assess changes from baseline in summary scores of domains of motor function, cognitive function, behavioral function, and functional abilities to capture the current disease status.
Time Frame
Collected for duration of study through month 60
Title
Changes over time in Quantitative Motor (Q-Motor) Testing
Description
Q-Motor testing will measure disease progression and responsiveness to AMT-130 treatment.
Time Frame
Collected for duration of study through month 60
Title
Changes over time in Huntington's Disease Cognitive Assessment Battery (HD-CAB)
Description
The HD-CAB measures cognitive dysfunction in late premanifest and early manifest HD patients.
Time Frame
Collected for duration of study through month 60
Title
Mean changes from baseline in Hospital Anxiety and Depression Scale (HADS
Description
The HADS is a 14-item, self-report measure that has been shown to be reliable and valid for identifying depression and anxiety in adults who are physically ill. Each item is scored from 0 (no anxiety or depression) to 3 (abnormal anxiety or depression) for a maximum total score of 21.
Time Frame
Collected for duration of study through month 60
Title
Changes over time in Neurological Disorders Quality of Life in Neurological Disorder Measures (Neuro-QoL)
Description
The Neuro-QoL is a brief, reliable, valid, standardized set of patient reported, Health Related Quality of Life (HRQoL) measures for people living with neurological conditions.
Time Frame
Collected for duration of study through month 60
Title
Magnetic Resonance Imaging (MRI) - Brain Volumes
Description
MRI assessments will include whole brain volume, striatal region volumes, white matter volume, gray matter volume, ventricular volume(cm^3)
Time Frame
Collected for duration of study through month 60
Title
Magnetic Resonance Imaging (MRI) - Cortical Thickness
Description
MRI assessments will include cortical thickness (mm)
Time Frame
Collected for duration of study through month 60
Title
Diffusion Magnetic Resonance Imaging (MRI)
Description
MRI assessments will include diffusion MRI measures mm2/s
Time Frame
Collected for duration of study through month 60
Title
Mean changes from baseline for Magnetic Resonance Spectroscopy (MRS)
Description
MRS will be collected using single-voxel point resolved spectroscopy of the left putamen and white matter region immediately adjacent to the left putamen. Neuronal health and gliosis will be evaluated by measuring total N-acetylaspartic acid (neuronal integrity marker) and myoinisitol (reactive astrocytosis marker) levels.
Time Frame
Collected for duration of study through month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Early manifest HD as defined by a UHDRS total functional capacity (TFC) score of 9 to 13 and EITHER a diagnostic classification level (DCL) of 4 OR a DCL of 3 if the subject either meets the definition of multidimensional manifest HD (UHDRS question 80) or DSM5
HTT gene expansion testing with the presence of ≥40 CAG repeats.
Striatal MRI volume requirements per hemisphere: Putamen ≥2.5 cm3 (per side); Caudate ≥2.0 cm3 (per side)
All HD concomitant medications (addressing motor, behavioral, and cognitive symptoms) stable for 3 months prior to Screening.
Able and willing to provide written informed consent
Able and willing to comply with all procedures and study visits
Exclusion Criteria:
Evidence of suicide risk
Receipt of an experimental agent within 60 days or five half-lives prior to Screening or anytime over the duration of this study.
Participation in an investigational trial or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc.) within 60 days prior to Screening or anytime over the duration of this study.
Presence of an implanted deep brain stimulation device, ventriculoperitoneal or other CSF shunt, or other implanted catheter
Any history of gene therapy, RNA or DNA targeted HD specific investigational agents, such as antisense oligonucleotides (ASO), cell transplantation or any other experimental brain surgery.
Any contraindication to lumbar puncture or 3.0 Tesla MRI as per local guidelines.
Brain and spinal pathology that may interfere with the surgical delivery of AMT-130 or represents a significant neurologic comorbid disorder.
Malignancy within 5 years of screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
Hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks of Screening or planned during the study.
Current or recurrent disease, infection, or other significant concurrent medical condition or medications that could confound clinical and laboratory evaluations or could affect a subject's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Lopez, MS
Phone
781-777-3697
Email
amt130_clinical_trials@uniqure.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Sullivan
Phone
339-970-7611
Email
amt130_clinical_trials@uniqure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Post, MD, PhD
Organizational Affiliation
UniQure Biopharma B.V.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Dreyer
Phone
+49 211 81-17246
Email
andrea.dreyer@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Jan Vesper
Facility Name
George Huntington Institute
City
Münster
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothee Schulte to Bühne
Phone
+49 251 788 7880
Email
dorothee.schultetobuehne@ghi-muenster.de
First Name & Middle Initial & Last Name & Degree
Ralf Reilmann
Facility Name
Interventional Neuro Center
City
Warsaw
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Dusza-Rowinska
Phone
+48 698 250 623
Email
neurol1@ipin.edu.pl
First Name & Middle Initial & Last Name & Degree
Grzegorz Witkowski
Facility Name
Cardiff University
City
Cardiff
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hel Hughes
Phone
+44 2920 745302
Email
Helen.Hughes10@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
William Gray
Facility Name
National Hospital for Neurology & Neurosurgery
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Alvarez
Email
miguel.alvarez.13@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Edward Wild
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease
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