Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02131467
Eligibility Criteria:
Inclusion Criteria:
* • 18-65 year old male and female patients with primary cervical dystonia.
* Subject may be untreated with botulinum toxin; treated with botulinum toxin but who are at least 8 weeks (+ 1 week) from a previous injection; or who have experienced an insufficient response to botulinum toxin in the opinion of the enrolling investigator. Note: We will aim to include subjects who have a stable response that lasts 12 weeks or longer.
* Subjects may be on stable anti-dystonia treatment (for at least one month) including anticholinergics, baclofen, and anxiolytics including benzodiazepines.
Exclusion Criteria:
* Secondary cervical dystonia,
* Significant dystonia in body areas other than cervical region,
* Cognitive impairment (e.g., Montreal Cognitive assessment (MOCA) \< 26);
* Active psychosis;
* History of aggression;
* Active depression (Hamilton Depression Rating Scale (HDRS) score ≥ 12).
* Current abuse of alcohol or subjects who do not agree to avoid alcohol during treatment,
* Substance abuse (current or prior);
* Active infection,
* Hypersensitivity to perampanel,
* Significant renal dysfunction (Creatinine clearance \< 50ml/min),
* Significant laboratory abnormalities (ALT or AST greater than twice normal value; elevated bilirubin, active liver disease: hepatitis, cholestasis, cirrhosis, etc.),
* Significant medical illness,
* Women who are pregnant or plan to become pregnant, women who are breastfeeding,
* Subjects who do not agree to avoid consumption of grapefruit or grapefruit-containing products throughout the study,
* Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
* Use of prohibited medications known to be inducers of CYP3A including, but not limited to: rifampicin, troglitazone, St John's Wort, efavirenz, nevirapine, barbiturates, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin; and any other interactions as per Product Monograph
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02131467
Study Brief:
Protocol Section:
NCT02131467