Trial · NCT00806026

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

NCT00806026, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-09-27

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ConductScience Library. Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients. Trials, record NCT00806026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00806026

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
NCT number: NCT00806026
Status: Completed
Phases: Phase 3
Enrollment: 731 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Idiopathic Restless Legs Syndrome
Interventions: placebo and pregabalin, pramipexol, pramipexol, Pregabalin, pramipexol, pramipexol
First posted: 2008-12-10
Last updated: 2021-01-26
Results first posted: 2012-09-27
Limitations and caveats: Names of Daytime Function-Participant Reported Outcome (DF-PRO) and Limb Pain-Numerical Rating Scale (Limb Pain-NRS) were updated to RLS-NDI and Limb Pain-VAS respectively to reflect measurement appropriately.

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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".
Primary	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	Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)	Baseline	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.
Secondary	Change From Baseline in SSQ: Subjective WASO at Week 12	Baseline, 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.
Secondary	Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12	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.
Secondary	Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12	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.
Secondary	Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12	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.
Secondary	Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12	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.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Restless Legs Syndrome (RLS) Symptom Severity	Baseline	Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	Units on a Scale	MEAN
PRIMARY	Change From Baseline in the RLS Symptom Severity at Week 12	Baseline, Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	Units on a Scale	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Participants Responding to Treatment at Week 12	Week 12	ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	Percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Augmentation	Baseline up to Week 52	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	Percentage of participants	NUMBER
SECONDARY	Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)	Baseline	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	minutes	MEAN
SECONDARY	Change From Baseline in SSQ: Subjective WASO at Week 12	Baseline, Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12	Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	minutes	MEAN
SECONDARY	Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12	Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	hours	MEAN
SECONDARY	Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12	Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	awakenings	MEAN
SECONDARY	Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12	Week 12	ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.	Units on a scale	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group159

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Restless Legs Syndrome (RLS) Symptom Severity	Pregabalin 300 mg	22.30	Standard Deviation 5.73	Units on a Scale
Restless Legs Syndrome (RLS) Symptom Severity	Pramipexole 0.25 mg	22.40	Standard Deviation 5.37	Units on a Scale
Restless Legs Syndrome (RLS) Symptom Severity	Pramipexole 0.5 mg	22.10	Standard Deviation 5.19	Units on a Scale
Restless Legs Syndrome (RLS) Symptom Severity	Placebo	22.40	Standard Deviation 5.58	Units on a Scale
Change From Baseline in the RLS Symptom Severity at Week 12	Pregabalin 300 mg	-11.80	Standard Error 0.47	Units on a Scale
Change From Baseline in the RLS Symptom Severity at Week 12	Pramipexole 0.25 mg	-7.90	Standard Error 0.49	Units on a Scale
Change From Baseline in the RLS Symptom Severity at Week 12	Pramipexole 0.5 mg	-10.50	Standard Error 0.47	Units on a Scale
Change From Baseline in the RLS Symptom Severity at Week 12	Placebo	-7.30	Standard Error 0.48	Units on a Scale
Percentage of Participants Responding to Treatment at Week 12	Pregabalin 300 mg	71.40		Percentage of participants
Percentage of Participants Responding to Treatment at Week 12	Pramipexole 0.25 mg	51.20		Percentage of participants

1 to 10 of 159Source ClinicalTrials.gov

See all 159 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin 300 mg	185
Overall Study	STARTED	Pramipexole 0.25 mg	183
Overall Study	STARTED	Pramipexole 0.5 mg	182
Overall Study	STARTED	Placebo to Pregabalin 300 mg	61
Overall Study	STARTED	Placebo to Pramipexole 0.25 mg	59
Overall Study	STARTED	Placebo to Pramipexole 0.5 mg	61
Overall Study	Treated	Pregabalin 300 mg	182
Overall Study	Treated	Pramipexole 0.25 mg	178
Overall Study	Treated	Pramipexole 0.5 mg	180
Overall Study	Treated	Placebo to Pregabalin 300 mg	59

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events444

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vertigo	Ear and labyrinth disorders	Pregabalin 300 mg	13	182
other	Vertigo	Ear and labyrinth disorders	Pramipexole 0.25 mg	2	178
other	Vertigo	Ear and labyrinth disorders	Pramipexole 0.5 mg	5	180
other	Vertigo	Ear and labyrinth disorders	Placebo to Pregabalin 300 mg	3	59
other	Vertigo	Ear and labyrinth disorders	Placebo to Pramipexole 0.25 mg	0	59
other	Vertigo	Ear and labyrinth disorders	Placebo to Pramipexole 0.5 mg	0	61
other	Vision blurred	Eye disorders	Pregabalin 300 mg	3	182
other	Vision blurred	Eye disorders	Pramipexole 0.25 mg	4	178
other	Vision blurred	Eye disorders	Pramipexole 0.5 mg	1	180
other	Vision blurred	Eye disorders	Placebo to Pregabalin 300 mg	3	59

1 to 10 of 444Source ClinicalTrials.gov

See all 444 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pregabalin 300 mg
Total, all-cause mortality	Pramipexole 0.25 mg
Total, all-cause mortality	Pramipexole 0.5 mg
Total, all-cause mortality	Placebo to Pregabalin 300 mg
Total, all-cause mortality	Placebo to Pramipexole 0.25 mg
Total, all-cause mortality	Placebo to Pramipexole 0.5 mg
Total, other adverse events	Pregabalin 300 mg	134	182
Total, other adverse events	Pramipexole 0.25 mg	110	178
Total, other adverse events	Pramipexole 0.5 mg	118	180
Total, other adverse events	Placebo to Pregabalin 300 mg	42	59

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24521108	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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