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NCT05529095
Sublingual Apomorphine in Refractory Restless Legs Syndrome
Phase 4 trial testing Apomorphine Sublingual Film in Restless Legs Syndrome in 16 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | William Ondo, MD |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 September 2022 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 March 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Apomorphine Sublingual Film — full drug profile →
- Placebo
Conditions studied
- Restless Legs Syndrome — all drugs for Restless Legs Syndrome →
Sponsor
William Ondo, MD — full company profile →
Who can join
Adults 21 to 80, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05529095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Restless Legs Syndrome
Currently open trials in the same condition.
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- NCT06866132 — Response to an Investigational Device in Patients With Restless Legs Syndrome · NA · active not recruiting
- NCT06684782 — Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease · recruiting
- NCT06806891 — Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis · NA · recruiting
- NCT06570941 — Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome · Phase 1, PHASE2 · active not recruiting
Other William Ondo, MD trials
Trials by the same sponsor.
- NCT05581576 — Pitolisant in Refractory Restless Legs Syndrome · Phase 4 · unknown
- NCT03229174 — Brain Perfusion & Oxygenation in Parkinson's Disease With NOH · Phase 4 · completed
- NCT02509793 — A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine) · Phase 4 · unknown
- NCT03218969 — Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist · Phase 1, PHASE2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05529095 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by William Ondo, MD
- Last refreshed: 6 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05529095.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing