Restless Legs Syndrome Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
William Ondo, MD | Sunovion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | International RLS Rating Scale (IRLS) | This is a subjective scale to measure the severity of RLS within the past week. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | The Restless Legs Syndrome - 6 Scale (RLS-6) | This scale measures the severity of daytime versus nighttime RLS symptoms. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL) | This scale assess the quality of life in RLS patients. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Hamilton Depression Scale (HDS) | This scale assess symptoms of depression. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Epworth Sleepiness Scale (ESS) | This is a subjective scale that measures a patient's sleepiness. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | 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. | 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04786314 -
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
|
N/A | |
Completed |
NCT01455012 -
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
|
Phase 4 | |
Terminated |
NCT01192503 -
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT00530530 -
ASP8825 - Study in Patients With Restless Legs Syndrome
|
Phase 2 | |
Completed |
NCT00721279 -
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
|
N/A | |
Completed |
NCT00375284 -
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
|
Phase 4 | |
Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
Completed |
NCT00479531 -
Sequential Compression Devices for Treatment of Restless Legs Syndrome
|
Phase 3 | |
Recruiting |
NCT05581576 -
Pitolisant in Refractory Restless Legs Syndrome
|
Phase 4 | |
Active, not recruiting |
NCT03218969 -
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
|
Phase 1/Phase 2 | |
Recruiting |
NCT04144790 -
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
|
||
Completed |
NCT05787080 -
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
|
N/A | |
Recruiting |
NCT05044520 -
Clinical Features Associated With Restless Legs Syndrome.
|
||
Withdrawn |
NCT03849001 -
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
|
N/A | |
Completed |
NCT03076541 -
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
|
N/A | |
Recruiting |
NCT04145674 -
A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo
|
Phase 2 | |
Completed |
NCT02532608 -
Infra-slow Oscillations During Sleep
|
N/A | |
Completed |
NCT01528462 -
Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
|
||
Completed |
NCT00748098 -
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
|
Phase 3 | |
Completed |
NCT00373542 -
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
|
Phase 4 |