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Pridopidine Open-Label Extension in Huntington's Disease (OPEN-HART)
NCT01306929Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- Jan 2018
- Sponsor
- Prilenia Therapeutics
- Modality
- Small Molecules
- Drugs
- pridopidine
- Conditions
- Huntington disease (HD)
01
Overview
Phase 2, open-label, single-arm trial of pridopidine in Huntington disease (HD), sponsored by Prilenia Therapeutics. Primary endpoint: Number of Patients With at Least One Adverse Event. Started Mar 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pridopidine
Pridopidine 45mg BID
03
Who it enrols
Patients with Huntington's Disease who completed the HART or PRIDE-HD studies, are willing to take oral medication, and have internet access for virtual visits. Excludes those on tetrabenazine, deutetrabenazine, or certain other medications, and those with a history of seizures or substance abuse.
04
Endpoints
Primary
Number of Patients With at Least One Adverse Event
Secondary
Unified Huntington's Disease Rating Scale Total Motor Score
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