Sublingual Apomorphine in Refractory Restless Legs Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, short placebo-controlled trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy. Investigators hypothesize that the study drug, sublingual apomorphine (Kynmobi), may improve RLS breakthrough symptoms. This study is designed to determine if sublingual apomorphine improves breakthrough symptoms in RLS patients, in addition to subjective responses.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Ondo, MD
• Collaborator: Sunovion
• Treatments: Apomorphine

Criteria

Inclusion Criteria:

• Idiopathic RLS diagnosed by standard criteria, with an IRLS > 15 while taking at least 1 RLS medication

• Stable RLS medications for at least 2 weeks prior to study entry

Exclusion Criteria:

• Concurrent untreated sleep disorders, not felt to be able stable

• Subjects with any significant, unstable cardiovascular, liver, lung, renal. psychiatric, or neurological diseases (not including RLS)

• Any medical or psychiatric comorbidity that, in the opinion of the investigator, would make study compliance difficult to achieve

• Intravenous iron within 4 weeks of study entry

• Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is a possibility (pre-menopausal, sexually active women)

• Subjects with previous allergic reaction to apomorphine or sulfate sensitivity

• Subjects currently taking 5HT3 antagonists