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

Huntington Disease Clinical Trial

— OPEN-HART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306929
• Other study ID #: ACR16C015
• Status: Completed
• Phase: Phase 2
• Start date: March 24, 2011
• Est. completion date: January 5, 2018

Study information

• Verified date: January 2022
• Source: Prilenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• pridopidine
45mg bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prilenia

References & Publications (1)

McGarry A, Auinger P, Kieburtz K, Geva M, Mehra M, Abler V, Grachev ID, Gordon MF, Savola JM, Gandhi S, Papapetropoulos S, Hayden M. Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease. J Huntingtons Dis. 2020;9(2):173-184. doi: 10.3233/JHD-190393. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With at Least One Adverse Event		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	Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)	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.	Baseline and at Month 12, 24, 36, 48, 60, and 72