Restless Legs Syndrome

36
Pipeline Programs
7
Companies
41
Clinical Trials
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
9
1
14
12
Early DiscoveryClinical DevelopmentMarket

On Market (5)

Approved therapies currently available

U
CABERGOLINEApproved
cabergoline
Unknown Company
Ergot Derivative [EPC]oral2024
Pfizer
DOSTINEXApproved
cabergoline
Pfizer
Ergot Derivative [EPC]oral1996
UP
NEUPROApproved
rotigotine
UCB Pharma
Nonergot Dopamine Agonist [EPC]transdermal2007
U
PITOLISANTApproved
pitolisant
Unknown Company
film coated
U
RASAGILINE MESYLATEApproved
rasagiline
Unknown Company
oral2019

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
16 programs
3
5
4
PramipexolePhase 41 trial
PramipexolePhase 41 trial
PramipexolePhase 41 trial
pramipexolePhase 41 trial
PramipexolePhase 31 trial
+11 more programs
Active Trials
NCT02248155Completed2,644
NCT02248142Completed1,029
NCT01170091Completed651
+13 more trials
UP
UCB PharmaBelgium - Brussels
15 programs
5
8
2
RotigotinePhase 41 trial
RotigotinePhase 41 trial
RotigotinePhase 31 trial
RotigotinePhase 31 trial
RotigotinePhase 31 trial
+10 more programs
Active Trials
NCT00247364Completed20Est. Oct 2005
NCT01495793Completed42Est. May 2014
NCT00498186Completed295Est. Apr 2009
+12 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
1
CabergolinePhase 35 trials
Active Trials
NCT01270711Completed22,014Est. Feb 2013
NCT00153972Completed39Est. Jan 2009
NCT00129181Completed30Est. Jan 2007
+2 more trials
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
1 program
1
PitolisantPhase 41 trial
Active Trials
NCT05581576UnknownEst. May 2023
Teva
TevaIsrael - Petach Tikva
1 program
1
rasagilinePhase 2/31 trial
Active Trials
NCT01192503Terminated52Est. Aug 2012
Ipsen
IpsenChina - Tianjin
1 program
1
BNTPhase 21 trial
Active Trials
NCT00949806Completed27Est. Nov 2011
Astellas
AstellasChina - Shenyang
1 program
RegniteN/A1 trial
Active Trials
NCT01887613Completed1,597Est. Feb 2019

Trial Timeline

Clinical trial activity over time

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

Showing 15 of 41 trials with date data

Clinical Trials (41)

Total enrollment: 34,648 patients across 41 trials

Pitolisant in Refractory Restless Legs Syndrome

Start: Sep 2022Est. completion: May 2023
Phase 4Unknown

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

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

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

Start: Jul 2006404 patients
Phase 4Completed

Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease

Start: Feb 2005Est. completion: Jan 200939 patients
Phase 4Completed

Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

Start: Jul 2004Est. completion: Sep 2005220 patients
Phase 4Terminated
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

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

Start: Apr 2008Est. completion: Jun 2009306 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

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

Start: May 2005Est. completion: Aug 2006549 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

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

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
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

Specified Drug Use-Results Survey of Regnite

Start: Oct 2012Est. completion: Feb 20191,597 patients
N/ACompleted

Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)

Start: Nov 2010Est. completion: Feb 201322,014 patients
N/ACompleted
NCT01170091Boehringer IngelheimSafety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Start: Dec 2007651 patients
N/ACompleted

Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

Start: Sep 2007549 patients
N/ACompleted

Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Start: Apr 20062,644 patients
N/ACompleted

Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Start: Feb 20061,029 patients
N/ACompleted

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

Start: Jan 2005Est. completion: Jan 200730 patients
N/ACompleted

Phase Legend

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

Key Insights

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