Pimavanserin Treatment in TS

March 10, 2021 updated by: Joseph Jankovic

An Open Label, Proof-of-Principle, Pilot Study to Evaluate Pimavanserin for the Treatment of Motor and Behavioral Symptoms of Tourette Syndrome

This research study is determining if a drug called Pimavanserin if safe and effective in the treatment of the symptoms of Tourette Syndrome. Pimavanserin is an investigational drug for Tourette Syndrome, which means it has not been approved by the United States Food and Drug Administration (FDA) to treat Tourette Syndrome. Pimavanserin has been approved by the FDA as a treatment for hallucinations in Parkinson's Disease. It is currently marketed under the name NUPLAZID (pimavanserin) capsules by Acadia Pharmaceuticals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tourette Syndrome is typically treated with drugs that block or reduce the function of dopamine (a brain chemical involved in movement). However, many of these drugs have adverse effects including irreversible, involuntary movements, typically affecting the face, known as tardive dyskinesia. Newer drugs may have lower risk of tardive dyskinesia. However, many of these drugs are still in clinical trials or are very expensive when used off-label (without FDA approval) to treat Tourette Syndrome. Given these limitations, exploring the potential of other drugs is essential in helping patients.

Several studies have shown that serotonin, another chemical in the brain like dopamine, may also play a role in the symptoms of Tourette Syndrome. Serotonin is already the target of many drugs in the treatment of depression, anxiety and obsessive-compulsive disorder which frequently occur in patients with Tourette Syndrome. Pimavanserin is also a drug that works on serotonin system. This means it may be helpful in the treatment of Tourette Syndrome.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Patient has a TTS of 20 or higher on the YGTSS at screening and baseline.
  • Patient can swallow study medical whole.
  • Patient is willing to adhere to the medication regimen and to comply with all study procedures.
  • Patient is in good general health, as indicated by the medical and psychiatric history as well as physical and neurological examination.
  • In the investigator's opinion, the patient has the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed.
  • Patient has provided written informed consent according to local regulations.
  • Females who are postmenarchal or greater than 12 years of age may be included if they have a negative urine pregnancy test at baseline or are sterile.
  • Females who are postmenarchal or great than 12 years of age who male partners are potentially fertile (i.e. no vasectomy) must use highly effective birth control methods for the duration of the study (i.e. starting at screening) and for 30 days or 5 half-lives, whichever is longer after last dose of pimavanserin. 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 the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pimavanserin
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
Pimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease.
Other Names:
  • Nuplazid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
A secondary objective is to evaluate the effect of pimavanserin on obsessive-compulsive behaviors associated with Tourette Syndrome using the Yale-Brown Obsessive Compulsive Scale. The minimum score of this scale is 0 and the maximum score of this scale is 40. A higher score represents greater severity of obsessive compulsive symptoms.
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Clinical Global Impression Scale. The minimum score of this scale is 1 and the maximum score of this scale is 7. A higher score suggests a more sever symptom.
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Patient Global Impression of Improvement Scale. The minimum score of this scale is 1 and the maximum score of this scale is 7. A higher score suggests symptoms are very much worse.
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics and obsessive-compulsive behaviors associated with Tourette Syndrome using the Columbia-Suicide Severity Rating Scale (C-SSRS). The minimum score of this scale is 2 and the maximum score of this scale is 25, with a higher score indicating more intense ideation and greater risk.
10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time Frame: 10 weeks
A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics and obsessive-compulsive behaviors associated with Tourette Syndrome using the Gilles de la Tourette Syndrome Quality of Life Scale. The minimum score is 0 and the maximum score is 108, with a higher score indicating extreme problems.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Jankovic

Collaborators

Andrew Billnitzer, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 12, 2018

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-43658

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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