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Restless Legs Syndrome

22
Pipeline Programs
14
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
4
0
10
4
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Pfizer
DOSTINEXApproved
cabergoline
Pfizer
Ergot Derivative [EPC]oral1996

Competitive Landscape

14 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
14 programs
3
2
6
1
pramipexolePhase 4
RopinirolePhase 3
Ropinirole Extended ReleasePhase 3
Ropinirole Extended ReleasePhase 3
Ropinirole IR 1 mgPhase 3
+9 more programs
Pfizer
PfizerNEW YORK, NY
3 programs
3
1
CabergolinePhase 31 trial
cabergolinePhase 31 trial
pregabalinPhase 31 trial
Active Trials
NCT00627003Completed43Est. May 2003
NCT00625547Completed361Est. Dec 2004
NCT00991276Completed85Est. Jun 2011
MSD
MSDIreland - Ballydine
1 program
1
SuvorexantPhase 41 trial
Active Trials
NCT04706091Completed46Est. Oct 2023
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
SuvorexantPhase 4
Astellas
AstellasChina - Shenyang
3 programs
1
1
ASP8825Phase 31 trial
ASP8825Phase 21 trial
RegniteN/A1 trial
Active Trials
NCT01887613Completed1,597Est. Feb 2019
NCT00530530Completed474Est. Jan 2009
NCT02658188Completed182Est. Apr 2009
Pharmacosmos
PharmacosmosDenmark - Holbaek
1 program
1
Iron isomaltoside 1000Phase 21 trial
Active Trials
NCT02484768Withdrawn0Est. Feb 2015
Synthonics
SynthonicsVA - Blacksburg
1 program
1
Chylobinoid Topical CreamPhase 1/21 trial
Active Trials
NCT06570941Active Not Recruiting10Est. Oct 2024
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
16 programs
PramipexoleN/A1 trial
PramipexoleN/A1 trial
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLSN/A1 trial
Sifrol®N/A1 trial
MIRAPEX® - lowPHASE_21 trial
+11 more programs
Active Trials
NCT02248155Completed2,644
NCT02248142Completed1,029
NCT01170091Completed651
+13 more trials
UCB Pharma
UCB PharmaBelgium - Brussels
15 programs
LevetiracetamPHASE_21 trial
RotigotinePHASE_21 trial
RotigotinePHASE_21 trial
RotigotinePHASE_21 trial
Rotigotine Nasal SprayPHASE_21 trial
+10 more programs
Active Trials
NCT00247364Completed20Est. Oct 2005
NCT01495793Completed42Est. May 2014
NCT00498186Completed295Est. Apr 2009
+12 more trials
GSK
GSKLONDON, United Kingdom
12 programs
Altered Brain GABA and Glutamate in Restless Legs SyndromeN/A1 trial
RopiniroleN/A1 trial
RopinirolePHASE_11 trial
Ropinirole Immediate ReleasePHASE_11 trial
ropinirole dosing for up to 28 daysPHASE_11 trial
+7 more programs
Active Trials
NCT01109537Completed75Est. May 2014
NCT01327339Completed755Est. Nov 2009
NCT00419692Completed32Est. Dec 2006
+9 more trials
Noctrix Health
Noctrix HealthCA - Pleasanton
8 programs
Investigational Noninvasive Neuromodulation DeviceN/A1 trial
NTX100N/A1 trial
NTX100 Neuromodulation SystemN/A1 trial
NTX100 Neuromodulation System - ActiveN/A1 trial
NTX100 Neuromodulation System - ActiveN/A1 trial
+3 more programs
Active Trials
NCT06866132Active Not Recruiting20Est. Sep 2025
NCT06076499Active Not Recruiting325Est. Dec 2026
NCT05196828Completed103Est. Nov 2022
+5 more trials
Ipsen
IpsenChina - Tianjin
1 program
BNTPHASE_21 trial
Active Trials
NCT00949806Completed27Est. Nov 2011
Teva
TevaIsrael - Petach Tikva
1 program
rasagilinePHASE_2_31 trial
Active Trials
NCT01192503Terminated52Est. Aug 2012
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
1 program
PitolisantPHASE_41 trial
Active Trials
NCT05581576Unknown18Est. May 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Harmony BiosciencesPitolisant
MSDSuvorexant
UCB PharmaRotigotine
UCB PharmaRotigotine
Boehringer IngelheimPramipexole
Boehringer IngelheimPramipexole
Boehringer Ingelheimpramipexole
Boehringer IngelheimPramipexole
GSKpramipexole
UCB PharmaRotigotine 1 mg/24 h
UCB PharmaRotigotine 1 milligram/24 hours
UCB PharmaRotigotine
UCB PharmaRotigotine
Pfizerpregabalin
Boehringer IngelheimPramipexole

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 8,682 patients across 50 trials

Pitolisant in Refractory Restless Legs Syndrome

Start: Sep 2022Est. completion: May 202318 patients
Phase 4Unknown
NCT04706091MSDSuvorexant

Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

Start: Aug 2021Est. completion: Oct 202346 patients
Phase 4Completed

Switching From Oral Dopamine Agonists to Rotigotine

Start: Aug 2014Est. completion: Dec 201521 patients
Phase 4Completed

Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome

Start: Sep 2011Est. completion: Jun 201281 patients
Phase 4Completed

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

Start: May 2007331 patients
Phase 4Completed

A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

Start: Sep 2006404 patients
Phase 4Completed

Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

Start: Jul 2006404 patients
Phase 4Completed

A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

Start: Jul 2006369 patients
Phase 4Completed
NCT00344994GSKpramipexole

SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole

Start: May 2006Est. completion: Apr 201020 patients
Phase 4Completed
NCT03992196UCB PharmaRotigotine 1 mg/24 h

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

Start: Dec 2019Est. completion: Sep 202210 patients
Phase 3Terminated
NCT03728933UCB PharmaRotigotine 1 milligram/24 hours

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Start: Dec 2018Est. completion: Jul 202223 patients
Phase 3Terminated

A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

Start: Apr 2012Est. completion: Oct 201330 patients
Phase 3Completed

Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)

Start: Mar 2012Est. completion: Apr 2013150 patients
Phase 3Completed

Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

Start: Dec 2009Est. completion: Jun 201185 patients
Phase 3Completed

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

Start: Apr 2008Est. completion: Jun 2009306 patients
Phase 3Completed

Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Start: Dec 2007Est. completion: Apr 2009182 patients
Phase 3Completed
NCT00357097GSKRopinirole

The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome

Start: Jun 2006Est. completion: Dec 2007240 patients
Phase 3Completed
NCT00314860GSKropinirole Extended Release

RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

Start: Feb 2006Est. completion: Dec 2006568 patients
Phase 3Completed

An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

Start: Dec 2005Est. completion: Dec 2007279 patients
Phase 3Completed

A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Start: Nov 2005Est. completion: Jul 200660 patients
Phase 3Completed
NCT00355641GSKRopinirole Extended Release

Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

Start: Oct 2005Est. completion: Oct 2007450 patients
Phase 3Completed
NCT00197080GSKRopinirole Extended Release

Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Start: Jun 2005Est. completion: Jan 2006380 patients
Phase 3Completed

Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Start: May 2005Est. completion: Nov 2006811 patients
Phase 3Completed

Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Start: May 2005Est. completion: Aug 2006549 patients
Phase 3Completed
NCT00225862GSKropinirole

A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

Start: Jan 2005Est. completion: Dec 2005140 patients
Phase 3Completed

Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

Start: Apr 2004Est. completion: Feb 2005345 patients
Phase 3Completed

A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

Start: Jan 2004224 patients
Phase 3Completed

Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome

Start: Feb 2003Est. completion: Feb 200558 patients
Phase 3Completed

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Start: Jan 2003Est. completion: Dec 2004361 patients
Phase 3Completed

A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Start: Nov 2002Est. completion: May 200343 patients
Phase 3Completed

Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients

Start: Oct 2002Est. completion: Apr 2004346 patients
Phase 3Completed
NCT01192503Tevarasagiline

Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Start: Sep 2010Est. completion: Aug 201252 patients
Phase 2/3Terminated
NCT02484768PharmacosmosIron isomaltoside 1000

IV Iron Treatment of Restless Legs Syndrome

Start: Jan 2015Est. completion: Feb 20150
Phase 2Withdrawn

Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

Start: Dec 2011Est. completion: Dec 201514 patients
Phase 2Completed

Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

Start: Dec 2011Est. completion: May 201442 patients
Phase 2Completed

Restless Legs Syndrome Treatment With Botulinum Toxin

Start: Aug 2009Est. completion: Nov 201127 patients
Phase 2Completed

ASP8825 - Study in Patients With Restless Legs Syndrome

Start: Sep 2007Est. completion: Jan 2009474 patients
Phase 2Completed
NCT00530790GSKropinirole controlled release

Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

Start: Aug 2007Est. completion: Feb 200835 patients
Phase 2Completed
NCT00389831UCB PharmaRotigotine Nasal Spray

Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

Start: Aug 2006Est. completion: Dec 200644 patients
Phase 2Completed

Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

Start: May 200626 patients
Phase 2Completed
NCT00152997Boehringer IngelheimPramipexole 0.125 mg tablets

Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

Start: Aug 200441 patients
Phase 2Completed

A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

Start: Nov 2003Est. completion: Oct 200520 patients
Phase 2Completed

Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

Start: Jul 2003Est. completion: Apr 2009295 patients
Phase 2Completed

Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

Start: Oct 2002Est. completion: Apr 2004109 patients
Phase 2Completed
NCT06570941SynthonicsChylobinoid Topical Cream

Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome

Start: Mar 2024Est. completion: Oct 202410 patients
Phase 1/2Active Not Recruiting
NCT00419692GSKRopinirole

Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

Start: Aug 2006Est. completion: Dec 200632 patients
Phase 1Completed
NCT00422994GSKropinirole dosing for up to 28 days

A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

Start: Apr 2006Est. completion: Dec 200648 patients
Phase 1Completed
NCT00140712GSKRopinirole Immediate Release

Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Start: Jun 2005Est. completion: Feb 20089 patients
Phase 1Completed
NCT07397247Noctrix HealthTonic Motor Activation

Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation

Start: Apr 2026Est. completion: Jan 202750 patients
N/ANot Yet Recruiting
NCT06866132Noctrix HealthInvestigational Noninvasive Neuromodulation Device

Response to an Investigational Device in Patients With Restless Legs Syndrome

Start: Mar 2025Est. completion: Sep 202520 patients
N/AActive Not Recruiting

Related Jobs

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

10 late-stage (Phase 3) programs, potential near-term approvals
14 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.