Sublingual Apomorphine (Kynmobi) for Restless Legs Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Houston Methodist Hospital, Houston, TX
Restless Legs Syndrome+2 More
Apomorphine Sublingual Film - Drug
Eligibility
18+
All Sexes
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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.

Eligible Conditions

  • Restless Legs Syndrome

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks

Week 20
Clinical Global Impressions - Change
Week 16
Epworth Sleepiness Scale (ESS)
Hamilton Depression Scale (HDS)
International RLS Rating Scale (IRLS)
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
The Restless Legs Syndrome - 6 Scale (RLS-6)
Weeks 4 - 8
Visual Analogue Scale of Improvement

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Sublingual Apomorphine (Kynmobi)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

16 Total Participants · 2 Treatment Groups

Primary Treatment: Sublingual Apomorphine (Kynmobi) · Has Placebo Group · Phase 4

Sublingual Apomorphine (Kynmobi)
Drug
Experimental Group · 1 Intervention: Apomorphine Sublingual Film · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Apomorphine Sublingual Film, Placebo · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks
Closest Location: Houston Methodist Hospital · Houston, TX
Photo of Houston Methodist Hospital  1Photo of Houston Methodist Hospital  2Photo of Houston  3
2014First Recorded Clinical Trial
2 TrialsResearching Restless Legs Syndrome
170 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.