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Sublingual Apomorphine in Refractory Restless Legs Syndrome

NCT05529095 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-09-06

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Apomorphine Sublingual Film

Sublingual Apomorphine initial dose 10 mg, titrated depending on symptomatic response.

DRUG

Placebo

Placebo (sugar pill)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • William Ondo, MD

    lead OTHER

Principal Investigators

  • William Ondo, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529095 on ClinicalTrials.gov