Safety and Tolerability of Perampanel in Cervical Dystonia (SAFE-PER-CD)
Cervical Dystonia
About this trial
This is an interventional treatment trial for Cervical Dystonia
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
Sites / Locations
- Emory University School of Medicine
- Rush University Medical Center
- Beth Israel Medical Center
- Cleveland Clinic
- Toronto Western Hospital
Arms of the Study
Arm 1
Experimental
Perampanel
Perampanel 2 mg tablets will be initiated once daily at bedtime. The dose will be titrated over 6 weeks starting at 2 mg OD at baseline visit for 1 week, followed by 2mg increases every 1 week to a maximum of 12 mg/day. If side effects occur then patients will be decreased to previous dose level. If unable to tolerate increases, patients will enter the maintenance phase at previously tolerated dose, for minimum 4 weeks. Patients reaching 12 mg (maximal dose) will be maintained at that dose for 4 weeks. Taper will be over 2 weeks 1 tablet every 2 days from a maximum of 6 tablets per day to stop.