Tourette SyndromeEarly Phase 1NCT04794413
Pimavanserin Treatment in TS
A Early Phase 1 study testing Pimavanserin in people with Tourette Syndrome and Tardive Dyskinesia, run by Joseph Jankovic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Tardive Dyskinesia
- What is being tested?
- Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 28 Feb 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tourette Syndrome, Tardive Dyskinesia
- Being tested
- Pimavanserin
- Keywords
- pimavanserin, Tourette Syndrome, tics
- Medical subject headings
- Tourette Syndrome, Tardive Dyskinesia, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Also called Nuplazid
Pimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (5)
Evaluate the effect of pimavanserin on Tourette Syndrome
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.
Measured: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
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.
Measured: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
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.
Measured: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
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.
Measured: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start12 Nov 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, proof-of-principle, 8-week treatment, pilot study for male and female patients aged 18 years and older with Tourette Syndrome. There were no control groups nor randomization.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Jankovic
- Sponsor type
- University, hospital or other
- Collaborators
- Andrew Billnitzer, MD
- Responsible party
- Sponsor-investigator, Joseph Jankovic, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794413
- Sponsor's protocol ID
- H-43658
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers.
Publications
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.
PubMed 21484868Thenganatt 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.
PubMed 26918185Billnitzer 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.
PubMed 32856174Robertson MM, Eapen V, Singer HS, Martino D, Scharf JM, Paschou P, Roessner V, Woods DW, Hariz M, Mathews CA, Crncec R, Leckman JF. Gilles de la Tourette syndrome. Nat Rev Dis Primers. 2017 Feb 2;3:16097. doi: 10.1038/nrdp.2016.97.
PubMed 28150698Paschou P, Fernandez TV, Sharp F, Heiman GA, Hoekstra PJ. Genetic susceptibility and neurotransmitters in Tourette syndrome. Int Rev Neurobiol. 2013;112:155-77. doi: 10.1016/B978-0-12-411546-0.00006-8.
PubMed 24295621Udvardi PT, Nespoli E, Rizzo F, Hengerer B, Ludolph AG. Nondopaminergic neurotransmission in the pathophysiology of Tourette syndrome. Int Rev Neurobiol. 2013;112:95-130. doi: 10.1016/B978-0-12-411546-0.00004-4.
PubMed 24295619Forde NJ, Kanaan AS, Widomska J, Padmanabhuni SS, Nespoli E, Alexander J, Rodriguez Arranz JI, Fan S, Houssari R, Nawaz MS, Rizzo F, Pagliaroli L, Zilhao NR, Aranyi T, Barta C, Boeckers TM, Boomsma DI, Buisman WR, Buitelaar JK, Cath D, Dietrich A, Driessen N, Drineas P, Dunlap M, Gerasch S, Glennon J, Hengerer B, van den Heuvel OA, Jespersgaard C, Moller HE, Muller-Vahl KR, Openneer TJ, Poelmans G, Pouwels PJ, Scharf JM, Stefansson H, Tumer Z, Veltman DJ, van der Werf YD, Hoekstra PJ, Ludolph A, Paschou P. TS-EUROTRAIN: A European-Wide Investigation and Training Network on the Etiology and Pathophysiology of Gilles de la Tourette Syndrome. Front Neurosci. 2016 Aug 23;10:384. doi: 10.3389/fnins.2016.00384. eCollection 2016.
PubMed 27601976Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
PubMed 2768151Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
PubMed 2684084Cavanna AE, Schrag A, Morley D, Orth M, Robertson MM, Joyce E, Critchley HD, Selai C. The Gilles de la Tourette syndrome-quality of life scale (GTS-QOL): development and validation. Neurology. 2008 Oct 28;71(18):1410-6. doi: 10.1212/01.wnl.0000327890.02893.61.
PubMed 18955683Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
PubMed 24001701Rothenberger A, Roessner V. Psychopharmacotherapy of Obsessive-Compulsive Symptoms within the Framework of Tourette Syndrome. Curr Neuropharmacol. 2019;17(8):703-709. doi: 10.2174/1570159X16666180828095131.
PubMed 30152283McDougle CJ, Goodman WK, Leckman JF, Barr LC, Heninger GR, Price LH. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. J Clin Psychopharmacol. 1993 Oct;13(5):354-8.
PubMed 8227493Leckman JF, Goodman WK, Anderson GM, Riddle MA, Chappell PB, McSwiggan-Hardin MT, McDougle CJ, Scahill LD, Ort SI, Pauls DL, et al. Cerebrospinal fluid biogenic amines in obsessive compulsive disorder, Tourette's syndrome, and healthy controls. Neuropsychopharmacology. 1995 Feb;12(1):73-86. doi: 10.1038/sj.npp.1380241.
PubMed 7766289Comings DE. Blood serotonin and tryptophan in Tourette syndrome. Am J Med Genet. 1990 Aug;36(4):418-30. doi: 10.1002/ajmg.1320360410.
PubMed 2389798
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Proof-of-Principle, Pilot Study to Evaluate Pimavanserin for the Treatment of Motor and Behavioral Symptoms of Tourette Syndrome
- ClinicalTrials.gov ID
- NCT04794413
- Acronym / sponsor ID
- H-43658
- Conditions
- Tourette Syndrome, Tardive Dyskinesia
- Keywords
- pimavanserin, Tourette Syndrome, tics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joseph JankovicUniversity, hospital or other
- Collaborators
- Andrew Billnitzer, MD
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, proof-of-principle, 8-week treatment, pilot study for male and female patients aged 18 years and older with Tourette Syndrome. There were no control groups nor randomization.
| Arm | Type | Receives |
|---|---|---|
| Pimavanserin | Experimental | Drug: PimavanserinAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimavanserinAlso: NuplazidPimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease. | Drug | Pimavanserin |
Primary outcome
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.
5 secondary outcomes
Evaluate the effect of pimavanserin on Tourette Syndrome
Time frame: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time frame: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time frame: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time frame: 10 weeks
Evaluate the effect of pimavanserin on Tourette Syndrome
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 21484868Jankovic J, Kurlan R. Tourette syndrome: evolving concepts. Mov Disord. 2011 May;26(6):1149-56. doi: 10.1002/mds.23618. Epub 2011 Apr 11.
- Background: PubMed 26918185Thenganatt 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.
- Background: PubMed 32856174Billnitzer 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.
- Background: PubMed 28150698Robertson MM, Eapen V, Singer HS, Martino D, Scharf JM, Paschou P, Roessner V, Woods DW, Hariz M, Mathews CA, Crncec R, Leckman JF. Gilles de la Tourette syndrome. Nat Rev Dis Primers. 2017 Feb 2;3:16097. doi: 10.1038/nrdp.2016.97.
- Background: PubMed 24295621Paschou P, Fernandez TV, Sharp F, Heiman GA, Hoekstra PJ. Genetic susceptibility and neurotransmitters in Tourette syndrome. Int Rev Neurobiol. 2013;112:155-77. doi: 10.1016/B978-0-12-411546-0.00006-8.
- Background: PubMed 24295619Udvardi PT, Nespoli E, Rizzo F, Hengerer B, Ludolph AG. Nondopaminergic neurotransmission in the pathophysiology of Tourette syndrome. Int Rev Neurobiol. 2013;112:95-130. doi: 10.1016/B978-0-12-411546-0.00004-4.
- Background: PubMed 27601976Forde NJ, Kanaan AS, Widomska J, Padmanabhuni SS, Nespoli E, Alexander J, Rodriguez Arranz JI, Fan S, Houssari R, Nawaz MS, Rizzo F, Pagliaroli L, Zilhao NR, Aranyi T, Barta C, Boeckers TM, Boomsma DI, Buisman WR, Buitelaar JK, Cath D, Dietrich A, Driessen N, Drineas P, Dunlap M, Gerasch S, Glennon J, Hengerer B, van den Heuvel OA, Jespersgaard C, Moller HE, Muller-Vahl KR, Openneer TJ, Poelmans G, Pouwels PJ, Scharf JM, Stefansson H, Tumer Z, Veltman DJ, van der Werf YD, Hoekstra PJ, Ludolph A, Paschou P. TS-EUROTRAIN: A European-Wide Investigation and Training Network on the Etiology and Pathophysiology of Gilles de la Tourette Syndrome. Front Neurosci. 2016 Aug 23;10:384. doi: 10.3389/fnins.2016.00384. eCollection 2016.
- Background: PubMed 2768151Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
- Background: PubMed 2684084Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
- Background: PubMed 18955683Cavanna AE, Schrag A, Morley D, Orth M, Robertson MM, Joyce E, Critchley HD, Selai C. The Gilles de la Tourette syndrome-quality of life scale (GTS-QOL): development and validation. Neurology. 2008 Oct 28;71(18):1410-6. doi: 10.1212/01.wnl.0000327890.02893.61.
- Background: PubMed 24001701Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
- Background: PubMed 30152283Rothenberger A, Roessner V. Psychopharmacotherapy of Obsessive-Compulsive Symptoms within the Framework of Tourette Syndrome. Curr Neuropharmacol. 2019;17(8):703-709. doi: 10.2174/1570159X16666180828095131.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pimavanserin in people with Tourette Syndrome and Tardive Dyskinesia, run by Joseph Jankovic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of pimavanserin on Tourette Syndrome (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794413, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.