Tourette SyndromePhase 2NCT02879578
Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
A Phase 2 study testing Valbenazine in people with Tourette Syndrome, run by Neurocrine Biosciences at 13 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 64 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Valbenazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 13 sitesUnited States
- Study dates
- 25 Jul 2016to 1 Nov 2017
- Phase
- Phase 2
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 6 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Fort Worth, Texas
Study site
Lincoln, Nebraska
Study site
Loxahatchee Groves, Florida
Study site
Naperville, Illinois
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norristown, Pennsylvania
Study site
San Diego, California
Study site
Spokane, Washington
Study site
St. Petersburg, Florida
Study site
Summit, New Jersey
Study site
Sun City, Arizona
Study site
Tampa, Florida
About this study
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).
- Conditions
- Tourette Syndrome
- Being tested
- Valbenazine
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called NBI-98854
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine (Children) | Experimental | Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period. Receives: Drug: Valbenazine |
| Valbenazine (Adolescents) | Experimental | Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period. Receives: Drug: Valbenazine |
| Valbenazine (Adults) | Experimental | Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment-emergent Adverse Events (TEAEs)
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing.
Measured: Baseline through Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start25 Jul 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879578
- Sponsor's protocol ID
- NBI-98854-1601
- Status last verified
- Apr 2021
- First submitted
- 10 Aug 2016
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes