Safety and Tolerability of Perampanel in Cervical Dystonia

• Status: Completed
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Cervical dystonia (CD) is the most common focal dystonia. Currently there are no effective oral medications for the treatment of CD. While botulinum toxin injections improve symptoms, they require repeated injections by a trained physician and some patients stop responding to injections or never respond at all. Therefore, alternative treatment options for CD are needed. One new agent is a drug that targets glutamate receptors that are thought to be involved dystonia. This drug, perampanel, was originally developed for epilepsy and is licensed for use in the USA and Canada for treating epilepsy. The purpose of this study is to test the effectiveness of perampanel in treating the symptoms of CD.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Dystonia Study Group

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