← Back to Search

Dopamine Agonist

Apomorphine Sublingual Film for Restless Legs Syndrome

Phase 4
Waitlist Available
Research Sponsored by William Ondo, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks
Awards & highlights

Study Summary

This trial is testing a new drug for restless legs syndrome, to see if it improves symptoms beyond what current treatments can do.

Eligible Conditions
  • Restless Legs Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Scale of Improvement
Secondary outcome measures
Clinical Global Impressions - Change
Epworth Sleepiness Scale (ESS)
Hamilton Depression Scale (HDS)
+3 more

Side effects data

From 2017 Phase 3 trial • 107 Patients • NCT02006121
47%
Infusion site nodule
20%
Nausea
19%
Somnolence
15%
Infusion site erythema
14%
Dyskinesia
13%
Insomnia
11%
Dizziness
10%
Headache
8%
Vomiting
8%
Infusion site haematoma
7%
Oedema peripheral
7%
Nasopharyngitis
7%
Back pain
6%
Fatigue
6%
Urinary tract infection
6%
Arthralgia
6%
Hallucination, visual
6%
Sleep disorder
6%
Orthostatic hypotension
5%
Dyspepsia
5%
Eosinophilia
5%
Electrocardiogram QT prolonged
5%
Infusion site pruritus
5%
Hallucination
2%
Fall
2%
Infusion site cellulitis
1%
Pulmonary embolism
1%
Constipation
1%
Delirium
1%
Confusional state
1%
Autoimmune haemolytic anaemia
1%
Haemoglobin decreased
1%
Red blood cell count decreased
1%
Hypotension
1%
Chest pain
1%
Angina pectoris
1%
Lower limb fracture
1%
Radius fracture
1%
Pathological fracture
1%
Lung neoplasm malignant
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Urinary retention
1%
Deep brain stimulation
1%
Diarrhoea
1%
Carotid artery stenosis
1%
Lymphopenia
1%
Myocardial infarction
1%
Colitis
1%
Blood disorder
1%
Gastrointestinal haemorrhage
1%
Cholelithiasis
1%
Forearm fracture
1%
Urosepsis
1%
Lymphoma
1%
Metastases to liver
1%
Neuroleptic malignant syndrome
1%
Parkinson's disease
1%
On Off phenomenon
1%
Paranoia
1%
Radicular syndrome
1%
Haematocrit decreased
1%
Umbilical hernia
1%
Eosinophil count decreased
1%
Device difficult to use
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apomorphine Hydrochloride
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sublingual Apomorphine (Kynmobi)Experimental Treatment1 Intervention
Sublingual apomorphine to be titrated after initial dose of 10 mg. Titration is dependent on subjects response.
Group II: PlaceboPlacebo Group2 Interventions
At week 4, subjects will be given randomization packet including 2 drug doses and 2 placebos.

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Industry Sponsor
236 Previous Clinical Trials
52,776 Total Patients Enrolled
William Ondo, MDLead Sponsor
4 Previous Clinical Trials
65 Total Patients Enrolled
2 Trials studying Restless Legs Syndrome
28 Patients Enrolled for Restless Legs Syndrome
SunovionIndustry Sponsor
191 Previous Clinical Trials
50,740 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to be included in this research?

"For this research study, 16 participants with restless leg syndrome between the age of 21 and 80 are necessary. Idiopathic RLS must be diagnosed in accordance to standard criteria as well as an IRLS score higher than 15 while taking 1+ medications for their condition. Additionally, medication stability over a 2-week period is required prior to enrollment."

Answered by AI

Is the recruitment process still open for this research endeavor?

"Reports from clinicaltrials.gov confirm that this specific medical trial is not presently seeking volunteers, notwithstanding the original posting date of September 1st 2022 and its recent update on the same day. Nevertheless, 1425 other trials are currently recruiting participants for their studies."

Answered by AI

Is Apomorphine Sublingual Film a safe option for patients with regards to side effects?

"Apomorphine Sublingual Film has been approved, so it was awarded a score of 3."

Answered by AI

Are there elderly participants in your research endeavor?

"The requirements for enrolment in this clinical trial necessitate that candidates are aged 21 to 80. For those below the age of majority, there exist 384 other studies while 1,011 trials welcome seniors past 65."

Answered by AI
~6 spots leftby Mar 2025