Clinical trial NCT02581865: Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. 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
5. Be in good general health
6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
7. 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

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a known history of substance dependence, substance (drug) or alcohol abuse
7. Have a significant risk of suicidal or violent behavior
8. Are currently pregnant or breastfeeding
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening

Primary outcomes:
measure: Change From Baseline to Week 8 in the YGTSS TTS
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8
timeFrame: Week 8
measure: Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score
timeFrame: Baseline, Week 8
measure: Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: National City
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Upland
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Natick
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Nashua
country: United States
state: New Hampshire
city: Summit
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Norristown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References: