Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
- Conditions
- Cervical Dystonia
- Registration Number
- NCT04871451
- Lead Sponsor
- AEON Biopharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria:<br><br> 1. Qualified for and had their initial dose of study drug in the ABP-19000 study.<br><br> 2. Provided written informed consent to being treated for cervical dystonia with<br> ABP-450.<br><br> 3. Were a male or female patient between 18 and 75 years of age (inclusive) when they<br> entered the ABP-19000 study.<br><br> 4. Stated willingness to comply with all study procedures, including attendance at the<br> study center for all study visits as scheduled and have technological capabilities<br> to have tele visits.<br><br>Exclusion Criteria:<br><br> 1. Participated in another interventional study during participation in this study.<br><br> 2. Were a pregnant or lactating female, or female of child-bearing potential not<br> willing to use an acceptable method of contraception (ie, intrauterine device,<br> barrier methods with spermicide, or abstinence).<br><br> 3. Would not benefit from treatment with ABP-450 for their cervical dystonia, in the<br> investigator's opinion.<br><br> 4. Viral or other active infection or any medical condition that, in the opinion of the<br> investigator, classifies the patient as unsuitable for participation in the study or<br> patients who do not seem to be in good general health at the time of Day 0<br> rollover, and prior to any investigational study drug administration.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-related Serious Adverse Events
- Secondary Outcome Measures
Name Time Method Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score;Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS);Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS);Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS);Mean Change in Patient Global Impression of Change (PGI-C);Mean Change in Clinical Global Impression of Change (CGI-C)