Ingrezza for Wryneck
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test Ingrezza, an oral medication taken once daily for 12 weeks, to evaluate its effectiveness in treating cervical dystonia, a condition causing neck spasms and abnormal head positions. Researchers are focusing on individuals who have had cervical dystonia for at least six months and experience moderate to severe head tremors or dystonic (twisted) neck postures. Those on a stable dose of Botulinum Toxin (such as Botox) for at least three months may be suitable candidates for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to further understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial requires that you do not use certain medications, like strong CYP3A4 inhibitors, digoxin, strong CYP2D6 inhibitors, and monoamine oxidase inhibitors. If you are on these, you may need to stop them to participate.
What is the safety track record for Ingrezza?
Research has shown that Ingrezza (valbenazine) is generally safe. In trials for conditions like tardive dyskinesia, most participants tolerated the drug well. Nearly everyone completed a 12-week study, and most managed the highest dose.
Common side effects included sleepiness in about 11% of participants, with mild effects like dry mouth or blurred vision in about 5%. Importantly, the FDA has already approved the drug for other conditions, indicating a known safety level.
While any treatment can have side effects, evidence suggests that most people tolerate Ingrezza well.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for cervical dystonia, which often include botulinum toxin injections, Ingrezza (Valbenazine) offers a unique approach by being an oral medication. Researchers are excited about Ingrezza because it targets vesicular monoamine transporter 2 (VMAT2), which is different from how other treatments work. This novel mechanism of action provides hope for improved symptom control and convenience for patients who may prefer oral administration over injections.
What is the effectiveness track record for Ingrezza in treating cervical dystonia?
Research has shown that Ingrezza (Valbenazine) effectively treats movement disorders like tardive dyskinesia, which resembles cervical dystonia. In past studies, Ingrezza significantly improved symptoms, with about 58.6% to 59.5% of patients experiencing remission. Patients reported lasting improvements with long-term use, suggesting it could help with symptoms. Although these studies focused on tardive dyskinesia, the success in reducing unwanted movements suggests it might also benefit those with cervical dystonia. Since it is approved for other movement disorders, Ingrezza is considered a promising option for this condition too. Participants in this trial will take Ingrezza orally once daily for 12 weeks to evaluate its effectiveness for cervical dystonia.678910
Who Is on the Research Team?
Martin Taylor, DO, PHD
Principal Investigator
principle investigator
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ingrezza orally once daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ingrezza
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive Ingrezza orally once daily for 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Orthopedic Foundation
Lead Sponsor
Citations
Patient-reported outcomes in tardive dyskinesia
Learn about the KINECT-PRO study design and patient reported outcomes with TD Impact Scale. See Prescribing Info, including Boxed Warning.
2.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/neurocrine-biosciences-debuts-new-data-for-effectiveness-of-ingrezza/Neurocrine Biosciences debuts new data for effectiveness ...
Of those who completed the trial, 58.6% of patients on 40mg reached remission while the 80mg group saw 59.5% doing the same. Results from the ...
Efficacy of Valbenazine (NBI-98854) in Treating Subjects with ...
Sustained TD improvements were found in subjects with SCHZ who received up to 48 weeks of VBZ, with TD reverting toward baseline when assessed 4 weeks after ...
4.
psychiatrictimes.com
psychiatrictimes.com/view/new-post-hoc-analysis-ingrezza-40-mg-leads-to-clinically-meaningful-improvements-in-tardive-dyskinesia-symptomsNew Post-Hoc Analysis: Ingrezza 40 mg Leads to Clinically ...
Continuous 48-week treatment with 40 mg valbenazine showed significant improvement in tardive dyskinesia symptoms, with rapid and sustained ...
5.
neurocrine.gcs-web.com
neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-patient-reported-outcomes-kinectRelease Details - Neurocrine Biosciences
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a ...
Safety profile in tardive dyskinesia
Incidence of suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) was 5.6% for INGREZZA 40 mg, 2.5% for INGREZZA 80 mg, and 5.3 ...
Ingrezza - accessdata.fda.gov
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction) ...
Safety and side effects of INGREZZA for HD chorea
INGREZZA SAFETY PROFILE Nearly all people (9 out of 10) taking INGREZZA completed the full 12-week clinical study, with 4 out of 5 able to tolerate the highest ...
Neurocrine Biosciences Publishes Analysis Showing Long ...
Overall, psychiatric stability was maintained through 48 weeks of treatment and INGREZZA was generally well tolerated. The most common treatment ...
Valbenazine (Ingrezza): The First FDA-Approved Treatment ...
Based on pooled data analysis, the most common adverse reactions were somnolence (10.9%) and anticholinergic effects (5.4%). Other adverse effects included ...
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