NCT05529095

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 1, 2022

Last Update Submit

September 1, 2022

Conditions

Restless Legs Syndrome

Keywords

Refractory

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale of Improvement

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

    Weeks 4 - 8

Secondary Outcomes (6)

  • International RLS Rating Scale (IRLS)

    Baseline, 4 weeks, 8 weeks, and 16 weeks

  • The Restless Legs Syndrome - 6 Scale (RLS-6)

    Baseline, 4 weeks, 8 weeks, and 16 weeks

  • Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)

    Baseline, 4 weeks, 8 weeks, and 16 weeks

  • Hamilton Depression Scale (HDS)

    Baseline, 4 weeks, 8 weeks, and 16 weeks

  • Epworth Sleepiness Scale (ESS)

    Baseline, 4 weeks, 8 weeks, and 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Sublingual Apomorphine (Kynmobi)

EXPERIMENTAL

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

Drug: Apomorphine Sublingual Film

Placebo

PLACEBO COMPARATOR

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

Drug: Apomorphine Sublingual FilmDrug: Placebo

Interventions

Apomorphine Sublingual FilmDRUG

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

Also known as: Kynmobi
PlaceboSublingual Apomorphine (Kynmobi)
PlaceboDRUG

Placebo (sugar pill)

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Sugars

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • William Ondo, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Ondo, MD

CONTACT

713-363-8184wondo@houstonmethodist.org

Shivani Desai, BS

CONTACT

7133638390sdesai5@houstonmethodist.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

US(1)