A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
- Conditions
- Obsessive Compulsive DisorderOCD10037173
- Registration Number
- NL-OMON52232
- Lead Sponsor
- Accelsiors CRO and Consultancy Services Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
1.Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of
the subject's illness must be >= 1 year;
2.Subjects must be currently experiencing non-response or inadequate response
to their current SOC medication defined as: Subjects Y-BOCS total score must be
>= 22 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
3.Subjects must currently be on an SSRI (with the exception of fluvoxamine, see
Section 1.1.3), or clomipramine, venlafaxine or desvenlafaxine monotherapy
treatment for an adequate duration and at an adequate dose defined as in
clinical trial protocol
4.Subjects must be on stable doses of other psychotropic medication (with
exclusions specified below) for at least 12 weeks prior to screening;
5.CGI-S score of >= 4 at screening and baseline;
6.Women of child bearing potential (WOCBP) and fertile men (including those
vasectomized for less than 6 months) with female partners whoare WOCBP (not
having undergone bilateral tubal occlusion procedure and not postmenopausal)
must agree to use highly effective birth control, including two methods of
contraception, for the duration of the study (i.e., beginning 30 days prior to
Baseline and extending to 30 days for women and 90 days for men after the last
dose of study drug). The
two methods of contraception should include:
i.One barrier method (e.g. diaphragm with spermicide, condom with spermicidal
gel, cervical cap)*
ii.One other method that could include hormonal contraceptives (e.g. combined
estrogen and progesterone containing, or progesterone only with oral, vaginal,
injectable, or transdermal route of administration), intrauterine device, or
intrauterine hormone releasing system used for at least 4 weeks prior to sexual
intercourse
7.WOCBP must have a negative serum pregnancy test at screening and a negative
urine pregnancy test within approximately 24 hours prior to dosing at Baseline
8.It is required that men who are sexually active with WOCBP agree to use two
methods of contraception for the duration of the study (beginning at first
treatment and extending to 90 days after the last dose of study drug).
1.Subjects with a history of more than two (2) previous failed or inadequate
treatment classes SSRIs, clomipramine, venlafaxine, or desvenlafaxine, given
for an adequate duration at an adequate dose as defined by the criteria taken
from the MGH-TRQ-OCD .
2.Subjects should be excluded at screening or baseline if any medical or
psychiatric condition other than OCD, as specified in the inclusion criteria,
could predominantly explain or contribute significantly to the subjects'
symptoms or that could confound assessment of OCD symptoms;
3.Current or prior history, per DSM-5 criteria, of bipolar I or II disorder,
schizophrenia or other psychotic disorders, schizoaffective disorder, autism or
autistic spectrum disorders, borderline personality disorder, antisocial
personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of
hoarding disorder as part of the OCD diagnosis are allowed, but a primary
diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's
disorder is also excluded;
4.Any eating disorder within the last 12 months;
5.Primary active major depressive episode or primary active anxiety disorder
within the past 6 months.
6.Acute suicidality or suicide attempt or self-injurious behavior in the last
12 months.
7.Any positive (yes) C-SSRS response to questions 1-5 in last 6 months at
screening and/or Since the Last Visit (before dosing) at the baseline visit;
9.Subjects who may have received a non-biological investigational agent in any
clinical trial within 30 days or a biological agent within 90 days prior to
screening;
10.History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive
Therapy (ECT).
11.History of substance use disorder (drug or alcohol) in the last 12 months,
with the exception of tobacco, as defined by DSM-5 criteria;
12.Positive urine drug screening for cannabis (both medical and recreational
use of cannabis are prohibited; subjects will be expected to refrain from use
during the period of the study), amphetamines (including MDMA/ecstasy),
cocaine, barbiturate, PCP, and/or opiates at screening.
13. Women who are pregnant or brestfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS<br /><br>change from baseline in the total score.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Safety and tolerability are assessed using the frequency of unique subjects<br /><br>with: SAEs; AEs leading to discontinuation; AEs judged to be related to study<br /><br>medication; and clinically significant laboratory abnormalities that are<br /><br>observed during the double-blind phase;<br /><br>• Improvement in functional disability is assessed using the change in the<br /><br>Sheehan Disability Scale (SDS) total score from baseline;<br /><br>• Improvement in global clinical condition is assessed using the change in the<br /><br>CGI-S score from baseline</p><br>