search
Back to results

Sublingual Apomorphine in Refractory Restless Legs Syndrome

Primary Purpose

Restless Legs Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Apomorphine Sublingual Film
Placebo
Sponsored by
William Ondo, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Refractory

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sublingual Apomorphine (Kynmobi)

Placebo

Arm Description

Sublingual apomorphine to be titrated after initial dose of 10 mg. Titration is dependent on subjects response.

At week 4, subjects will be given randomization packet including 2 drug doses and 2 placebos.

Outcomes

Primary Outcome Measures

Visual Analogue Scale of Improvement
Subjects will assess how they feel 30 minutes after taking four doses of drug or placebo.

Secondary Outcome Measures

International RLS Rating Scale (IRLS)
This is a subjective scale to measure the severity of RLS within the past week.
The Restless Legs Syndrome - 6 Scale (RLS-6)
This scale measures the severity of daytime versus nighttime RLS symptoms.
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
This scale assess the quality of life in RLS patients.
Hamilton Depression Scale (HDS)
This scale assess symptoms of depression.
Epworth Sleepiness Scale (ESS)
This is a subjective scale that measures a patient's sleepiness.
Clinical Global Impressions - Change
This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention.

Full Information

First Posted
September 1, 2022
Last Updated
September 1, 2022
Sponsor
William Ondo, MD
Collaborators
Sumitomo Pharma America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05529095
Brief Title
Sublingual Apomorphine in Refractory Restless Legs Syndrome
Official Title
Open Label and Placebo-Controlled Assessment of Sublingual Apomorphine (Kynmobi) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Ondo, MD
Collaborators
Sumitomo Pharma America, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sublingual Apomorphine (Kynmobi)
Arm Type
Experimental
Arm Description
Sublingual apomorphine to be titrated after initial dose of 10 mg. Titration is dependent on subjects response.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
At week 4, subjects will be given randomization packet including 2 drug doses and 2 placebos.
Intervention Type
Drug
Intervention Name(s)
Apomorphine Sublingual Film
Other Intervention Name(s)
Kynmobi
Intervention Description
Sublingual Apomorphine initial dose 10 mg, titrated depending on symptomatic response.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo (sugar pill)
Primary Outcome Measure Information:
Title
Visual Analogue Scale of Improvement
Description
Subjects will assess how they feel 30 minutes after taking four doses of drug or placebo.
Time Frame
Weeks 4 - 8
Secondary Outcome Measure Information:
Title
International RLS Rating Scale (IRLS)
Description
This is a subjective scale to measure the severity of RLS within the past week.
Time Frame
Baseline, 4 weeks, 8 weeks, and 16 weeks
Title
The Restless Legs Syndrome - 6 Scale (RLS-6)
Description
This scale measures the severity of daytime versus nighttime RLS symptoms.
Time Frame
Baseline, 4 weeks, 8 weeks, and 16 weeks
Title
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
Description
This scale assess the quality of life in RLS patients.
Time Frame
Baseline, 4 weeks, 8 weeks, and 16 weeks
Title
Hamilton Depression Scale (HDS)
Description
This scale assess symptoms of depression.
Time Frame
Baseline, 4 weeks, 8 weeks, and 16 weeks
Title
Epworth Sleepiness Scale (ESS)
Description
This is a subjective scale that measures a patient's sleepiness.
Time Frame
Baseline, 4 weeks, 8 weeks, and 16 weeks
Title
Clinical Global Impressions - Change
Description
This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention.
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Ondo, MD
Phone
713-363-8184
Email
wondo@houstonmethodist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shivani Desai, BS
Phone
7133638390
Email
sdesai5@houstonmethodist.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ondo, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivani Desai, BS
Phone
713-363-8390
Email
sdesai5@houstonmethodist.org

12. IPD Sharing Statement

Learn more about this trial

Sublingual Apomorphine in Refractory Restless Legs Syndrome

We'll reach out to this number within 24 hrs