Sublingual Apomorphine in Refractory Restless Legs Syndrome

September 1, 2022 updated by: William Ondo, MD

Open Label and Placebo-Controlled Assessment of Sublingual Apomorphine (Kynmobi) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label, with a short placebo-controlled portion trial using sublingual apomorphine (Kynmobi) in RLS patients inadequately treated with standard therapy, defined by an IRLS > 15 and report of breakthrough symptoms.

At the initial visit, subjects will undergo all baseline and exploratory assessments and be given their first drug dose of 10 mg. They will be monitored for 60 minutes after dose. Subjects orthostatic blood pressure will be taken before ingestion, then 10, 20, 30, and 45 minutes after ingestion. Over the next 4 weeks, subjects will titrate Kynmobi to find optimal dose. Subjects will be instructed to take at least 2 doses before determining if further titration is needed.

At week 4, subjects will return for exploratory assessments. Subjects will be given a randomized study drug packet containing 2 placebos and 2 drug doses. Subjects will be told that 0-4 doses may be placebo or drug. Subjects will have 4 weeks to complete randomization doses. It is anticipated subjects will complete randomization sooner, so they will be given 23 doses of study drug (1 dose per 24 hours for 23 extra days until next visit).

At week 8, subjects will return for exploratory assessments and be given an additional 74 dosed strips. They will return at week 16 for a final visit and undergo exploratory assessments, followed by a safety call two weeks later.

From weeks 0-8, subjects are able to continue their scheduled RLS medications. From weeks 8-16, subjects may make changes to their RLS medications as mutually agreed upon with investigator.

Several questionnaire assessments will be conducted throughout the study to monitor subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS - 6), RLS Quality of Life Questionnaire (RLSQoL), RLS Augmentation Scale, Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sublingual Apomorphine (Kynmobi)
Sublingual apomorphine to be titrated after initial dose of 10 mg. Titration is dependent on subjects response.
Drug: Apomorphine Sublingual Film
Sublingual Apomorphine initial dose 10 mg, titrated depending on symptomatic response.
Other Names:
  • Kynmobi
Placebo Comparator: Placebo
At week 4, subjects will be given randomization packet including 2 drug doses and 2 placebos.
Drug: Apomorphine Sublingual Film
Sublingual Apomorphine initial dose 10 mg, titrated depending on symptomatic response.
Other Names:
  • Kynmobi
Drug: Placebo
Placebo (sugar pill)
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale of Improvement
Time Frame: Weeks 4 - 8
Subjects will assess how they feel 30 minutes after taking four doses of drug or placebo.
Weeks 4 - 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Restless Legs Syndrome - 6 Scale (RLS-6)
Time Frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
This scale measures the severity of daytime versus nighttime RLS symptoms.
Baseline, 4 weeks, 8 weeks, and 16 weeks
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
Time Frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
This scale assess the quality of life in RLS patients.
Baseline, 4 weeks, 8 weeks, and 16 weeks
Hamilton Depression Scale (HDS)
Time Frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
This scale assess symptoms of depression.
Baseline, 4 weeks, 8 weeks, and 16 weeks
Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
This is a subjective scale that measures a patient's sleepiness.
Baseline, 4 weeks, 8 weeks, and 16 weeks
International RLS Rating Scale (IRLS)
Time Frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
This is a subjective scale to measure the severity of RLS within the past week.
Baseline, 4 weeks, 8 weeks, and 16 weeks
Clinical Global Impressions - Change
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks
This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention.
1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Ondo, MD

Collaborators

Sunovion

Investigators

  • Principal Investigator: William Ondo, MD, The Methodist Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00033518

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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