A study testing if pridopidine is safe and efficacious in patients with Huntington's Disease

Phase 1

• Conditions: Huntington's disease; MedDRA version: 19.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000904-24-NL
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-17
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

a. Patient has completed the PRIDE-HD ( TV7820-CNS-20002) trial within the last 6 months, including the follow-up period, or transitioned from Open-HART. For patients that have failed to complete PRIDE-HD or those who completed the PRIDE-HD study over 6 months prior to the screening visit, and meet all other inclusion criteria, eligibility should be discussed with the Open-PRIDE medical monitor and clinician on a case-by-case basis.
b. For patients that experienced a drug-related serious adverse event (SAE) or had a major compliance violation during PRIDE-HD or Open-HART, eligibility approval should be discussed with PRIDE-HD’s or Open-HART medical monitor and clinician. Patients that experienced an adverse event/ serious adverse event of suicidal ideation/ behavior will be excluded without discussion.
c. Able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
d. Females of child bearing potential have to be compliant in using adequate birth control throughout the duration of the study. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception according to local regulations (hormone-based, intrauterine device, or double barrier contraception, i.e., condom and diaphragm). Abstinence is an acceptable method of contraception only when this is the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Male study participants have to be compliant in using adequate birth control with their partners (as defined above) throughout the duration
of the study.
e. Body weight =50 kg. Patients that meet this criterion at screening but fail to meet it at a subsequent visit may be discontinued based on Investigator or Sponsor discretion. It is allowed to repeat the weight measurement once, if clinically appropriate.
f. Willing and able to take oral medication and able to comply with the study specific procedures.
g. Ambulatory, being able to travel to the study center, and judged by the investigator as likely to be able to continue to travel for the duration of the study.
h. The patient is in good health as determined by medical examination, ECG, serum chemistry, hematology, and urinalysis.
i. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for evaluation as specified in this protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

a. A prolonged QTcF interval (defined as a QTcF interval of >450 msec) at the screening visit. ECGs will be performed in triplicate during the screening visit, and the mean of the 3 QTcF measurements will be used to determine whether or not the patient is suitable for inclusion in the study.
b. Patients with clinically significant heart disease at the screening visit, defined as follows: (i) significant cardiac event (eg, myocardial infarction), angina pectoris or episode of congestive heart failure with symptoms >Grade 2 New York Heart Association classification within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the investigator increased the risk of ventricular arrhythmia, (ii) history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, (iii) presence of left bundle branch block.
c. Patients with serum potassium, magnesium, and/or calcium levels outside of the central laboratory’s reference range at the screening visit and considered clinically significantly abnormal by the investigator. Repeat testing is allowed (up to a maximum of 3 tests) if required to establish whether values are within normal range or clinically significantly abnormal.
d. Patients receiving medications (within the last 6 weeks prior to baseline) other than pridopidine that have been proven to prolong QT interval or who may require such medications during the course of the study such as but not limited to non-allowed anti-psychotic medications, tricyclic antidepressants, and/or Class I antiarrhythmics.
e. Patients receiving medications (within the last 6 weeks prior to baseline) other than pridopidine that are metabolized by CYP2D6 and have the potential of reducing seizure threshold.
f. Patients with a history of epilepsy or of seizures within the last 5 years.
g. Creatinine clearance <60 mL/min at screening, calculated using the Cockcroft-Gault equation: (140 - age) × mass (kg) × [0.85 if female] / 72 × serum creatinine (mg/ dL). It is allowed to repeat the test once, if clinically appropriate.
h. Any clinically significant, abnormal, screening laboratory result which in the opinion of the investigator, affects the patients’ suitability for the study or puts the patient at risk if he/she enters the study.
i.Patients with adverse events of suicidal ideation or attempt at any time in the past or as measured by suicide ideation score of =3on the C-SSRS, or PBA-s or patients who answer Yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) if the attempt or acts were performed at any time in the past, or patients who, in the opinion of the investigator, present a risk of suicide.
j. Females who are pregnant or breastfeeding.
k. Treatment with any investigational product other than pridopidine within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified