Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease

Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is able to, and has provided written Informed Consent prior to any study related procedure.
Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
Willing and able to take oral medication and able to comply with the study specific procedures.
Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.
Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.

Additional criteria apply, please contact the investigator for more information

Exclusion criteria

Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
Newly instigated or changed treatment with neuroleptics/antipsychotics
Use of tricyclic antidepressants or class I & III antiarrhythmics at any time during the study period.
Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
Females who are pregnant or lactating.
Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
Known allergy to any ingredients of the trial medication.

Additional criteria apply, please contact the investigator for more information

Treatment and study plan

pridopidine

Drug

45mg bid

Primary outcomes

Number of Patients With at Least One Adverse Event

Time frame: From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years

Secondary outcomes

Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)

Time frame: Baseline and at Month 12, 24, 36, 48, 60, and 72

TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124.

Sponsors and collaborators

Lead sponsor

Prilenia

Industry

Registry information

Official study title

A Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).

Acronym: OPEN-HART

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Mar 2, 2011
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed