Pimavanserin Treatment in TS

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Brief Title

Pimavanserin Treatment in TS

Official Title

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

Brief Summary

      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.
    

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 Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Evaluate the effect of pimavanserin on Tourette Syndrome

Secondary Outcome

 Evaluate the effect of pimavanserin on Tourette Syndrome

Condition

Tourette Syndrome

Intervention

Pimavanserin

Study Arms / Comparison Groups

 Pimavanserin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

November 12, 2018

Completion Date

February 28, 2021

Primary Completion Date

February 28, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04794413

Organization ID

H-43658


Responsible Party

Sponsor-Investigator

Study Sponsor

Joseph Jankovic

Collaborators

 Andrew Billnitzer, MD

Study Sponsor

, , 


Verification Date

March 2021