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A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease

NCT ID: NCT03019289

Last Updated: 2021-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2018-02-09

Brief Summary

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The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted

Detailed Description

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Conditions

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Health Volunteers, Huntington Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pridopidine

Pridopidine (TV-7820) capsules

Group Type EXPERIMENTAL

pridopidine (90 mg)

Intervention Type DRUG

single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.

Interventions

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pridopidine (90 mg)

single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In general, good physical health as determined by medical history and psychiatric history, suicidality assessment \& physical examination
* Men who are potentially fertile (not surgically \[eg, vasectomy\] or congenitally sterile
* Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after 18 years of age

* Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* The subject has been previously exposed to ionizing radiation or radioactive substances as a result of clinical research or medical treatment in the past 10 years.
* The subject has a counterindication to having an MRI
* History of alcohol, narcotic, or any other substance dependence in the past 2 years
* The patient has a severe motor impairment that might cause artifacts.
* Patients with a known history of Long QT Syndrome or a first degree relative with this condition.
* Treatment with any investigational product within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.

* Additional criteria apply, please contact the investigator for more information
Minimum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Prilenia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Pharmaceuticals USA

Locations

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Teva Investigational Site 32648

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Grachev ID, Meyer PM, Becker GA, Bronzel M, Marsteller D, Pastino G, Voges O, Rabinovich L, Knebel H, Zientek F, Rullmann M, Sattler B, Patt M, Gerhards T, Strauss M, Kluge A, Brust P, Savola JM, Gordon MF, Geva M, Hesse S, Barthel H, Hayden MR, Sabri O. Sigma-1 and dopamine D2/D3 receptor occupancy of pridopidine in healthy volunteers and patients with Huntington disease: a [18F] fluspidine and [18F] fallypride PET study. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1103-1115. doi: 10.1007/s00259-020-05030-3. Epub 2020 Sep 29.

Reference Type BACKGROUND
PMID: 32995944 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-001757-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV7820-IMG-10082

Identifier Type: -

Identifier Source: org_study_id