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Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

Primary Purpose

Trichotillomania (Hair-Pulling Disorder)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Valbenazine Oral Capsule
Placebo Oral capsule
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania (Hair-Pulling Disorder) focused on measuring trichotillomania, hair-pulling disorder, valbenazine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have documentation of written and witnessed consent from the subject
  2. Male or female adult between the ages of 18-65, inclusive
  3. Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG
  4. On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial
  5. Subjects of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable).
  6. Female subjects must have a negative urine pregnancy test at Day 1 (baseline).
  7. Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates or cannabinoids) at screening and baseline. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study.
  8. Subjects must have a negative alcohol breath test at screening and at Day 1 (baseline).
  9. Be willing to adhere to the study regime and study procedures described in the protocol and informed consent forms, including all requirements at the study center and return for the follow-up visit
  10. Have symptoms that cause marked distress or significant impairment in occupational and/or social function
  11. Have a stable psychiatric status (TTM) as clinically determined by the investigator.
  12. Meet DSM-5 criteria for TTM
  13. Significant current TTM symptoms: 17 or greater score on NIMH-TSS/TIS

Exclusion Criteria:

  1. Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70)
  2. Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation.
  3. Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
  4. Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD)
  5. Taking co-medications (over the counter or prescription) that may have a drug interaction with valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present.
  6. Positive pregnancy test or drug screening test
  7. Currently pregnant or lactating
  8. Significant medical comorbidity
  9. Excessive use of tobacco and/or nicotine-containing products (based on the investigator's assessment or more than 1½ pack of cigarettes per day, 1 can of chewing/dipping tobacco per day, 54mg of nicotine-containing smoking cessation products per day, or any nicotine products or combination of products that exceed 54mg per day) within 30 days of screening
  10. History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder
  11. Known history of neuroleptic malignant syndrome
  12. Known history of long QT syndrome or cardiac arrhythmia
  13. Have a screening or Day 1 average triplicate ECG corrected QT interval using Fridericia's formula(33) (QTcF) of >450msec or the presence of any clinically significant cardiac abnormality
  14. Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline).
  15. Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement.
  16. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine).
  17. Have a history of or suspected poor compliance in clinical research studies.
  18. Have previous experience with valbenazine or previously participated in a valbenazine clinical study

Sites / Locations

  • Yale Child Study CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valbenazine

Placebo

Arm Description

Participants randomized1:1 to receive valbenazine

Participants randomized 1:1 to receive placebo

Outcomes

Primary Outcome Measures

Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.

Secondary Outcome Measures

Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint
Each of the Clinical Global Improvement Scale -Trichotillomania (CGI-TTM) response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. Responder status on Clinical Global Improvement Scale as having a CGI-TTM score at endpoint less than or equal to 2.

Full Information

First Posted
December 21, 2021
Last Updated
October 12, 2023
Sponsor
Yale University
Collaborators
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05207085
Brief Title
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability, and Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
October 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Neurocrine Biosciences

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.
Detailed Description
Eligible subjects will be randomized in a double-blind manner in a 1:1 ratio to once-daily doses of valbenazine or placebo for 12 weeks. After week 12, all subjects will begin the 12-week, open-label portion of the study in which they all get their optimal dose. Follow-up assessments will be conducted at the end of week 26 (2 weeks after the last dose of the study drug). For subjects randomized to active treatment, the starting dose will be valbenazine 40mg, which may be escalated to 80mg to achieve an optimal dose of valbenazine for each subject. Dose escalation will occur at the end of week 2 based on the following criteria: 1) the subject's TTM symptoms are not sufficiently controlled per physician investigator assessment and 2) an evaluation by the physician investigator indicates that the subject is tolerating the study drug at the current dose and would likely be able to tolerate the higher dose level. At week 4, the physician investigator may choose to keep the subject at the higher dose or may reduce to the subject's prior tolerated dose (in subjects who have had dose escalation). If a subject's optimal dose was established as 40mg at week 2, no dose escalation will be allowed at week 4. At any time after week 2, the physician investigator may decrease the dose to the previous dose for any subject who had a dose escalation and who is unable to tolerate a given dose increase. The investigator may reduce the subject's dose only one time. Subjects who are unable to tolerate the starting dose or resumption of the 40mg dose will be discontinued from the study. The subject will continue at the dose reached during the optimization period for the remainder of the 12-week treatment period. To maintain the study blind, subjects randomized to placebo in each weight group will be subjected to the same dose escalation requirements, but will receive only placebo during the treatment period. Following the 12-week, double-blind study, all subjects will be offered the option to receive open-label valbenazine for 12 weeks. In order to protect the blind in the first phase of the trial all subjects will receive 40mg of valbenazine from week 12 to week 14 and then be titrated on the study medication similar to the first phase of the trial from that point forward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania (Hair-Pulling Disorder)
Keywords
trichotillomania, hair-pulling disorder, valbenazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valbenazine
Arm Type
Experimental
Arm Description
Participants randomized1:1 to receive valbenazine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized 1:1 to receive placebo
Intervention Type
Drug
Intervention Name(s)
Valbenazine Oral Capsule
Other Intervention Name(s)
Ingrezza
Intervention Description
Participants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject.
Intervention Type
Other
Intervention Name(s)
Placebo Oral capsule
Intervention Description
Participants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period.
Primary Outcome Measure Information:
Title
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Description
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.
Time Frame
baseline to week12
Secondary Outcome Measure Information:
Title
Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint
Description
Each of the Clinical Global Improvement Scale -Trichotillomania (CGI-TTM) response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. Responder status on Clinical Global Improvement Scale as having a CGI-TTM score at endpoint less than or equal to 2.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have documentation of written and witnessed consent from the subject Male or female adult between the ages of 18-65, inclusive Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial Subjects of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable). Female subjects must have a negative urine pregnancy test at Day 1 (baseline). Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates or cannabinoids) at screening and baseline. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study. Subjects must have a negative alcohol breath test at screening and at Day 1 (baseline). Be willing to adhere to the study regime and study procedures described in the protocol and informed consent forms, including all requirements at the study center and return for the follow-up visit Have symptoms that cause marked distress or significant impairment in occupational and/or social function Have a stable psychiatric status (TTM) as clinically determined by the investigator. Meet DSM-5 criteria for TTM Significant current TTM symptoms: 17 or greater score on NIMH-TSS/TIS Exclusion Criteria: Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70) Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation. Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications). Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD) Taking co-medications (over the counter or prescription) that may have a drug interaction with valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present. Positive pregnancy test or drug screening test Currently pregnant or lactating Significant medical comorbidity Excessive use of tobacco and/or nicotine-containing products (based on the investigator's assessment or more than 1½ pack of cigarettes per day, 1 can of chewing/dipping tobacco per day, 54mg of nicotine-containing smoking cessation products per day, or any nicotine products or combination of products that exceed 54mg per day) within 30 days of screening History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder Known history of neuroleptic malignant syndrome Known history of long QT syndrome or cardiac arrhythmia Have a screening or Day 1 average triplicate ECG corrected QT interval using Fridericia's formula(33) (QTcF) of >450msec or the presence of any clinically significant cardiac abnormality Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline). Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine). Have a history of or suspected poor compliance in clinical research studies. Have previous experience with valbenazine or previously participated in a valbenazine clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angeli Landeros, MD
Phone
203737-4539
Email
blochresearch@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H. Bloch, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeli Landeros, MD
Phone
203-737-4539
Email
angeli.landeros@yale.edu
First Name & Middle Initial & Last Name & Degree
Michael Bloch, MD
Phone
(203)785-6906
Email
michael.bloch@yale.edu

12. IPD Sharing Statement

Citations:
Citation
United States Prescribing Information for INGREZZA. San Diego, CA 92130: Neurocrine Biosciences, Inc.; 2020.
Results Reference
background
PubMed Identifier
27581696
Citation
Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
Results Reference
background
PubMed Identifier
17727824
Citation
Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.
Results Reference
background
PubMed Identifier
25108618
Citation
McGuire JF, Ung D, Selles RR, Rahman O, Lewin AB, Murphy TK, Storch EA. Treating trichotillomania: a meta-analysis of treatment effects and moderators for behavior therapy and serotonin reuptake inhibitors. J Psychiatr Res. 2014 Nov;58:76-83. doi: 10.1016/j.jpsychires.2014.07.015. Epub 2014 Jul 26.
Results Reference
background
PubMed Identifier
21797657
Citation
Franklin ME, Zagrabbe K, Benavides KL. Trichotillomania and its treatment: a review and recommendations. Expert Rev Neurother. 2011 Aug;11(8):1165-74. doi: 10.1586/ern.11.93.
Results Reference
background
PubMed Identifier
29338466
Citation
Sarva H, Henchcliffe C. Valbenazine as the first and only approved treatment for adults with tardive dyskinesia. Expert Rev Clin Pharmacol. 2018 Mar;11(3):209-217. doi: 10.1080/17512433.2018.1429264. Epub 2018 Jan 23.
Results Reference
background

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Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

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