Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Idiopathic Restless Legs Syndrome Clinical Trial

— RLS  

Official title:

Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806026
• Other study ID #: A0081186
• Status: Completed
• Phase: Phase 3
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 to screening

Exclusion Criteria:

• Any secondary RLS

• Current augmentation due to RLS treatment

• Placebo responders identified during the placebo run-in

Related Conditions & MeSH terms

• Idiopathic Restless Legs Syndrome
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• placebo and pregabalin
following 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.
• pramipexol
following 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.
• pramipexol
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
• Pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
• pramipexol
pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
• pramipexol
pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Innsbruck
Austria	Pfizer Investigational Site	Linz
Austria	Pfizer Investigational Site	Wien
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Tampere
Finland	Pfizer Investigational Site	Turku
Germany	Pfizer Investigational Site	Achim
Germany	Pfizer Investigational Site	Bad Saarow
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bochum
Germany	Pfizer Investigational Site	Bochum
Germany	Pfizer Investigational Site	Bremen
Germany	Pfizer Investigational Site	Dortmund
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Gelsenkirchen
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Hamm
Germany	Pfizer Investigational Site	Jena
Germany	Pfizer Investigational Site	Juelich
Germany	Pfizer Investigational Site	Kassel
Germany	Pfizer Investigational Site	Kassel
Germany	Pfizer Investigational Site	Koethen
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Oldenburg
Germany	Pfizer Investigational Site	Prien
Germany	Pfizer Investigational Site	Schwerin
Germany	Pfizer Investigational Site	Siegen
Germany	Pfizer Investigational Site	Ulm
Germany	Pfizer Investigational Site	Ulm
Germany	Pfizer Investigational Site	Unterhaching
Germany	Pfizer Investigational Site	Westerstede
Germany	Pfizer Investigational Site	Wuerzburg
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Rome
Italy	Pfizer Investigational Site	Rome
Italy	Pfizer Investigational Site	Troina
Italy	Pfizer Investigational Site	Troina(EN)
Netherlands	Pfizer Investigational Site	Ede
Netherlands	Pfizer Investigational Site	Zwolle
Spain	Pfizer Investigational Site	Barcelona	Cataluña/Spain
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Granada
Spain	Pfizer Investigational Site	Madrid
Sweden	Pfizer Investigational Site	Avesta
Sweden	Pfizer Investigational Site	Avesta
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Örebro
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Skövde
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Reading Berks
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Chevy Chase	Maryland
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jasper	Alabama
United States	Pfizer Investigational Site	Lafayette Hill	Pennsylvania
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newton	Massachusetts
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Princeton	New Jersey
United States	Pfizer Investigational Site	Redondo Beach	California
United States	Pfizer Investigational Site	Salisbury	North Carolina
United States	Pfizer Investigational Site	Salisbury	North Carolina
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Tuscaloosa	Alabama
United States	Pfizer Investigational Site	Walla Walla	Washington
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Austria,  Finland,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restless Legs Syndrome (RLS) Symptom Severity	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.	Baseline
Primary	Change From Baseline in the RLS Symptom Severity at 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.	Baseline, Week 12
Primary	Percentage of Participants Responding to Treatment at 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".	Week 12
Primary	Percentage of Participants With Augmentation	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.	Baseline up to Week 52
Secondary	Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.	Baseline
Secondary	Change From Baseline in SSQ: Subjective WASO at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.	Baseline, Week 12
Secondary	Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.	Week 12
Secondary	Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.	Week 12
Secondary	Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.	Week 12
Secondary	Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.	Week 12
Secondary	RLS-Next Day Impact (RLS-NDI)	The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.	Baseline
Secondary	Change From Baseline in RLS-NDI at Week 12	The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.	Baseline, Week 12
Secondary	Limb Pain-Visual Analog Scale (Limb Pain-VAS)	100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.	Baseline
Secondary	Change From Baseline in Limb Pain-VAS at Week 12	100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.	Baseline, Week 12
Secondary	Severity of Augmentation Symptoms at Week 12	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.	Week 12
Secondary	Clinical Global Impressions-Severity (CGI-S) at Week 12	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.	Week 12
Secondary	Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12	MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.	Week 12
Secondary	Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12	MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.	Week 12
Secondary	Profile of Mood State (POMS) at Week 12	POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on 'How you feel right now?' (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 - 100, with higher score indicating more mood disturbance.	Week 12
Secondary	Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12	RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.	Week 12
Secondary	Medical Outcomes Study-Short Form 36 (SF-36) at Week 12	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from "0=much worse now" to "4=much better now". Higher subscale and summary score reflect better health status.	Week 12
Secondary	Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12	WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.	Week 12

External Links

•   To obtain contact information for a study center near you, click here.