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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 June 2021 |
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Main ID: |
NCT03225846 |
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Date of registration:
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17/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
PRECISION-HD2 |
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington's Disease |
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Date of first enrolment:
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July 17, 2017 |
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Target sample size:
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88 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03225846 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Australia
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Canada
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Denmark
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France
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Germany
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Poland
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United Kingdom
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Contacts
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Name:
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Medical Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wave Life Sciences |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
- Ambulatory, male or female patients aged =25 - =65 years
- Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease
Rating Scale (UHDRS) Diagnostic Confidence Score = 4
- Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores
=7 and =13
Key Exclusion Criteria:
- Malignancy or received treatment for malignancy, other than treated basal cell or
squamous cell carcinoma of the skin, within the previous 5 years
- Received investigational drug or implantable device in prior 3 months or
investigational oligonucleotide in prior 6 months or 5 halflives of the
oligonucleotide, whichever is longer
- Clinically significant medical condition, unstable psychiatric symptoms, substance
abuse, or pregnancy
- Inability to undergo brain MRI
- Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or
unsuccessful lumbar puncture
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
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Intervention(s)
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Drug: WVE-120102
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Drug: Placebo
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Primary Outcome(s)
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Safety: Severity of AEs
[Time Frame: Day 1 to Day 210 (end of study)]
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Safety: Number of patients with serious AEs (SAEs)
[Time Frame: Day 1 to Day 210 (end of study)]
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Safety and Tolerability: Number of patients who withdraw due to AEs
[Time Frame: Day 1 to Day 210 (end of study)]
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Safety: Number of patients with adverse events (AEs)
[Time Frame: Day 1 to Day 210 (end of study)]
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Secondary Outcome(s)
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Pharmacodynamics (PD)
[Time Frame: Day 1 to Day 196]
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Pharmacokinetics (PK): Maximum observed concentration (Cmax)
[Time Frame: Day 1 to Day 196]
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PK: Terminal elimination rate constant
[Time Frame: Day 1 to Day 196]
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PK: Time of occurrence of Cmax (tmax)
[Time Frame: Day 1 to Day 196]
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Clinical Effects: Total Functional Capacity (TFC)
[Time Frame: Day 1 to Day 140]
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PK: Area under the plasma concentration-time curve (AUC 0-t)
[Time Frame: Day 1 to Day 196]
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Secondary ID(s)
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WVE-HDSNP2-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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