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pramipexol

Phase 3

Idiopathic Restless Legs Syndrome | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 26, 2021

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment731
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00806026Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome PatientsPHASE3 COMPLETED 731Dec 1, 2008May 1, 2011Jan 26, 2021110 United States, Austria +7
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Study Endpoints
Primary Endpoints
Restless Legs Syndrome (RLS) Symptom Severity
Baseline

International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.

Change From Baseline in the RLS Symptom Severity at Week 12
Baseline, Week 12

IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.

Percentage of Participants Responding to Treatment at Week 12
Week 12

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of "very much improved" or "much improved".

Percentage of Participants With Augmentation
Baseline up to Week 52

Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.

Secondary Endpoints
Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)
Baseline
Change From Baseline in SSQ: Subjective WASO at Week 12
Baseline, Week 12
Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PBO/PGB 300 mgEXPERIMENTAL -
PBO/PPX 0.25 mgACTIVE_COMPARATOR -
PBO/PPX 0.5 mgACTIVE_COMPARATOR -
PGB 300 mgEXPERIMENTAL -
PPX 0.25 mgACTIVE_COMPARATOR -
PPX 0.5 mgACTIVE_COMPARATOR -
Interventions
NameTypeDescription
placebo and pregabalinDRUGfollowing 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
pramipexolDRUGfollowing 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
PregabalinDRUGpregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria: * idiopathic RLS with the presence of all four clinical manifestations of RLS * RLS symptoms occur predominantly in the evening * RLS history at least 6 months * IRLS =\> 15 at the beginning and the end of placebo run-in * Have =\>15 nights with RLS symptoms in the month prior t...

Countries:United StatesAustriaFinlandGermanyItalyNetherlandsSpainSwedenUnited Kingdom
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