Trials Sponsors Conditions Drugs Pricing

Conditions

Tardive Dyskinesia Tourette Syndrome

Keywords

pimavanserinTourette Syndrometics

Outcome Measures

Primary Outcomes (1)

Evaluate the effect of pimavanserin on Tourette Syndrome
The primary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Tourette Syndrome using the Yale Global Tic Severity Scale. The minimum score for this scale is 0 and the maximum score for this scale 100. A higher score suggests a more sever Tic or that the Tic has a greater impact on the person's life.
10 weeks

Secondary Outcomes (5)

Evaluate the effect of pimavanserin on Tourette Syndrome
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
10 weeks

Study Arms (1)

Pimavanserin

EXPERIMENTAL

All participants will receive pimavanserin 17mg once daily for 1 week and, if the tics are deemed to be inadequately controlled then increase to 34 mg once daily, taken orally as two 17 mg tablets once daily.

Drug: Pimavanserin

Interventions

PimavanserinDrug

Pimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease.

Also known as: Nuplazid

Pimavanserin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients 18 years of age or older
Patients meet the Diagnostic and Statistical Manuel of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for TS and, in the opinion of the investigator and patient, the patient's active tics are causing distress or impairment.

Sponsors & Collaborators

Andrew Billnitzer, MD
Type not reportedcollaborator
Joseph Jankovic
Otherlead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Related Publications (25)

Jankovic J, Kurlan R. Tourette syndrome: evolving concepts. Mov Disord. 2011 May;26(6):1149-56. doi: 10.1002/mds.23618. Epub 2011 Apr 11.
PMID: 21484868BACKGROUND
Thenganatt MA, Jankovic J. Recent Advances in Understanding and Managing Tourette Syndrome. F1000Res. 2016 Feb 9;5:F1000 Faculty Rev-152. doi: 10.12688/f1000research.7424.1. eCollection 2016.
PMID: 26918185BACKGROUND
Billnitzer A, Jankovic J. Current Management of Tics and Tourette Syndrome: Behavioral, Pharmacologic, and Surgical Treatments. Neurotherapeutics. 2020 Oct;17(4):1681-1693. doi: 10.1007/s13311-020-00914-6.

MeSH Terms

Conditions

Tourette SyndromeTardive DyskinesiaTics

Interventions

pimavanserin

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 12, 2021

Study Start

November 12, 2018

You may not qualify if:

Patient has a neurological disorder other than TS that could obscure the evaluation of tics.
The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
Patient has a DSM diagnosis at screening that, in the opinion of the investigator, makes the patient unsuitable for the study.
Patient has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for OCD within 4 weeks of screening.
Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
Stroke or other uncontrolled serious medical illness such as myocardial infarction within 6 months of baseline.
Patient with unknown QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotics medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin).
Patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.
Patient has evidence of hepatic impairment.
Patient has a known allergy to any of the components of pimavanserin.
Patient has participated in an investigational drug or device study and received intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
Patient is a pregnant or lactating female, or plans to be pregnant during the study.
Patient has a history of or acknowledges alcohol-related disorder in the previous 12 months, as defined in the DSM-5.
Patient has a positive urine drug screen test result or is unable to refrain from substance abuse throughout the study.

Pimavanserin Treatment in TS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Pimavanserin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Pimavanserin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations