Clinical trial NCT02879578: Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).


Eligibility criteria: Inclusion Criteria:

* Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
* Have a clinical diagnosis of Tourette Syndrome (TS)
* If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
* Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
* Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
* Be in good general health

Exclusion Criteria:

* Have an active, clinically significant unstable medical condition within 1 month prior to screening
* Have a known history of long QT syndrome or cardiac arrhythmia
* Have a known history of neuroleptic malignant syndrome
* Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
* Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
* Have a known history of substance dependence, substance (drug) or alcohol abuse
* Have a significant risk of suicidal or violent behavior
* Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

Primary outcomes:
measure: Frequency of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline through Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Loxahatchee Groves
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Naperville
country: United States
state: Illinois
city: Lincoln
country: United States
state: Nebraska
city: Summit
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Norristown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
Study officials:
References: