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Safety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease

StatusActive, Not Recruiting
PhasePhase 1/2
Started2021-10-07
View on ClinicalTrials.gov ↗

Amendment history

2025-03-05
Study Identification, Study Status, Study Design v12
Study titlerevised
Safety and Efficacy of AMT-130 in European Adults withWith Early Manifest Huntington's Disease
2024-11-12
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Study sites6→4
2024-10-22
Study Identification, Study Status, Oversight, Study Design, Contacts/Locations, IPDSharing v10
Enrollment target15→14
Study sitescontacts updated at 2 of 6 sites
Study titlerevised
Safety and Efficacy of AMT-130 in European Adults Withwith Early Manifest Huntington's Disease
2024-07-30
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 6 sites
2024-07-26
Study Status, Contacts/Locations v8
Re-verified, no change to tracked fields
Show 7 earlier versions
2024-07-18
Study Status, Contacts/Locations v7
Study sitescontacts updated at 2 of 6 sites
2024-05-30
Study Status, Eligibility v6
Eligibility criteria+86 characters
[...] organ transplantation or who test positive at Screening for the human immunodeficiency virus (HIV); or who are at risk of p [...] munosuppressed, including participants who test positive at Screeningscreening for hepatitis C virus antibody (anti-HCV), orhepatitis C virus ribonucleic acid (HCV RNA), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); or who have history of active tuberculosis or a positive tuberculosis blood test during Screeningscreening. For participants with an indeterminate tuberculosis blood [...] aindication to immunosuppression regimens in this protocol. . A [...]
2024-05-02
Study Status, Arms and Interventions v5
Re-verified, no change to tracked fields
2024-04-29
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2027-03→2029-03
Completion date2027-10-07→2029-10-07
Study arms2→3
Eligibility criteria+3,015 characters
Inclusion Criteria: EarlyAble manifestand HDwilling asto definedprovide bywritten ainformed UHDRSconsent totalprior functionalto capacitythe (TFC)study scoreand study-related procedure. Male and female participants 25-65 years of 9age. Cohorts to1 13& and EITHER 2: a diagnostic classification level (DCL) of 4 OR a DCL of 3 ifwith either a positive ("Yes") response to the subjectUHDRS eitherQuestion meets80 the definition of (multidimensional manifest HDdiagnosis (UHDRSon questionmotor, 80cognitive, behavioral, functional) or DSM5 criteria for cognitive disorder (American Psychiatric Associatio [...] [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study description+442 characters
[...] ety and efficacy. CT-AMT-130-02 is a Phase Ib/II open-label (Cohorts 1 & 2), randomized (Cohort 3 only) sequential ascendingmultiple dose study that will be conducted in approximately 5 to 8 European HD centers; 3 to 42 of these centers will serve as surgical sites. Both studies [...] ered treatment of patients within each of the dosing cohorts Cohort 3 participants will receive either high or low dose AMT-130. Following completion of the Month 36 visit, they will be unblinded to their treatment arm. Cohort 3 will further evaluate the safety and exploratory efficacy data of low or high dose AMT-130. [...]
Study sitesdetails revised at 3 of 6 sites
2023-05-09
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 6 sites
2022-09-09
Study Identification, Study Status, Conditions, Contacts/Locations v2
Study sitesdetails revised at 2 of 6 sites
Study title+2 characters
Safety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease
2022-02-17
Study Status, Contacts/Locations v1
Study sitesdetails revised at 1 of 6 sites
2022-02-07
Original filing
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. Cohort 3 participants will receive either high or low dose (1:1 randomization). Participants enrolled in Cohort 3 will also receive an immunosuppression regimen consisting of dexamethasone, sirolimus, and rituximab.
Trial Details
NCT Number NCT05243017
Lead Sponsor UniQure Biopharma B.V.
Conditions Huntington Disease
Enrollment 14 participants
Start Date 2021-10-07
Primary Completion 2029-03 (estimated)
Study Completion 2029-10-07 (estimated)
Updated on ClinicalTrials.gov 2025-03-10