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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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12 December 2020 |
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Main ID: |
NCT02494778 |
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Date of registration:
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07/07/2015 |
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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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A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Open PRIDE-HD |
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Scientific title:
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A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD) |
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Date of first enrolment:
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September 24, 2015 |
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Target sample size:
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248 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02494778 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Austria
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Canada
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Denmark
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France
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Germany
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Italy
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Netherlands
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Poland
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Russian Federation
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United Kingdom
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United States
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Contacts
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Name:
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Teva Medical Expert, 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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Teva Pharmaceuticals USA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pride HD completion within the last 6 months, including 2 week follow up period or
patients who transitioned from the Open HART study or patients who complete future
safety and efficacy clinical trials of pridopidine. In addition, patients who have
already completed their defined study period under Open PRIDE HD global or local
amendments and have discontinued treatment with pridopidine will be allowed to re
enter the Open PRIDE HD study.
- Women of child bearing potential or male participants: Adequate contraception and
birth control
- Good general health
- other criteria apply, please contact the investigator for more information
Exclusion Criteria:
- Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal
function to PRIDE HD;
- Similar concomitant medication restrictions to PRIDE HD.
- other criteria apply, please contact the investigator for more information
Age minimum:
21 Years
Age maximum:
N/A
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: Pridopidine
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Primary Outcome(s)
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Percentage of participants with adverse events
[Time Frame: 364 weeks]
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Secondary Outcome(s)
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Proportion of subjects (%) who prematurely discontinued from the study
[Time Frame: 364 weeks]
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Proportion of subjects (%) who prematurely discontinued from the study due to AEs
[Time Frame: 364 weeks]
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Secondary ID(s)
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TV7820-CNS-20016
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2015-000904-24
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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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