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Ropinirole XL

Phase 3

Parkinson Disease | Small molecule | Neurology |GSK plc|Last Updated: Jun 19, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment545
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00632736An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s DiseasePHASE3 COMPLETED 419Feb 1, 2004Mar 1, 2010Mar 23, 201775 United States, Belgium +7
NCT00650104Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164PHASE3 COMPLETED 76May 1, 2002Mar 1, 2009May 6, 201310 United States
NCT01371682A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and ArandaPHASE1 COMPLETED 50Sep 18, 2009Dec 2, 2009Jun 19, 20181 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
13 February 2004 through 31 March 2010

AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.

Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78

The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.

Number of Participants With the Indicated Number of Adverse Events (AEs)
Every study visit from baseline to market availability (Month 78)

AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.

PK samples will be measured for each formulation and compared between sites. The units of measure for this will include PK parameters, for example, Bioavailability, clearance and volume of distribution and Area under the curve.
6 months

PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2

Secondary Endpoints
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Week 4 and Week 26
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
Screening; Months 3, 9, 15, 27, and 78
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
Screening; Months 3, 9, 15, 27, and 78
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ropinirole XL (formerly CR)ACTIVE_COMPARATORRopinirole XL (formerly CR)
ActiveACTIVE_COMPARATOROpen label medication - Ropinirole CR
Session 1OTHERRopinirole manufactued at Crawley will be compared to that manufactured at Aranda
Session 2OTHERRopinirole manufactured at Crawley will be compared to that manufactured at Aranda.
Interventions
NameTypeDescription
Ropinirole XL (formerly CR)DRUG -
Ropinirole XLDRUGRopinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites75

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down...

Countries:United StatesBelgiumCzechiaFranceHungaryItalyPolandSpainUnited Kingdom
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