Trial · NCT00676403
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT00676403, Phase 2, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-02-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients. Trials, record NCT00676403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00676403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
- NCT number
- NCT00676403
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- placebo, Pregabalin, Pregabalin, Pregabalin, Pregabalin, Pregabalin
- First posted
- 2008-05-13
- Last updated
- 2021-02-10
- Results first posted
- 2010-02-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Baseline, Week 6 | IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline. |
| Secondary | Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Week 6 | Clinical Global Impression - Improvement Scale (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. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved. |
| Secondary | Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S) | Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF) | CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. |
| Secondary | Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep \[in minutes\]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline. |
| Secondary | Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before. |
| Secondary | Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline. |
| Secondary | Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline. |
| Secondary | Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline. |
| Secondary | Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline. |
| Secondary | Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Baseline, Week 6 | ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Week 6 | ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating. | participants | NUMBER |
| SECONDARY | Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S) | Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF) | ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward. | participants | NUMBER |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group792
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Placebo | -7.73 | Standard Error 1.720 | scores on scale | |
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Pregabalin 50 mg | -11.83 | Standard Error 1.771 | scores on scale | |
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Pregabalin 100 mg | -11.76 | Standard Error 1.694 | scores on scale | |
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Pregabalin 150 mg | -16.02 | Standard Error 1.865 | scores on scale | |
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Pregabalin 300 mg | -12.89 | Standard Error 1.713 | scores on scale | |
| Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Pregabalin 450 mg | -16.26 | Standard Error 1.771 | scores on scale | |
| Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Placebo | Week 6: Responders (n=21, 20, 22, 18, 23, 20) | 13 | participants | |
| Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Pregabalin 50 mg | Week 6: Responders (n=21, 20, 22, 18, 23, 20) | 12 | participants | |
| Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Pregabalin 100 mg | Week 6: Responders (n=21, 20, 22, 18, 23, 20) | 15 | participants | |
| Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Pregabalin 150 mg | Week 6: Responders (n=21, 20, 22, 18, 23, 20) | 11 | participants |
1 to 10 of 792Source ClinicalTrials.gov
See all 792 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | STARTED | Pregabalin 50 mg | 22 | |
| Overall Study | STARTED | Pregabalin 100 mg | 23 | |
| Overall Study | STARTED | Pregabalin 150 mg | 22 | |
| Overall Study | STARTED | Pregabalin 300 mg | 24 | |
| Overall Study | STARTED | Pregabalin 450 mg | 23 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | COMPLETED | Pregabalin 50 mg | 20 | |
| Overall Study | COMPLETED | Pregabalin 100 mg | 22 | |
| Overall Study | COMPLETED | Pregabalin 150 mg | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events642
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 | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 23 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 50 mg | 1 | 22 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 100 mg | 0 | 23 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 150 mg | 0 | 22 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 300 mg | 0 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin 450 mg | 0 | 23 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 23 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 50 mg | 0 | 22 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 100 mg | 0 | 23 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 150 mg | 1 | 22 |
1 to 10 of 642Source ClinicalTrials.gov
See all 642 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pregabalin 50 mg | ||
| Total, all-cause mortality | Pregabalin 100 mg | ||
| Total, all-cause mortality | Pregabalin 150 mg | ||
| Total, all-cause mortality | Pregabalin 300 mg | ||
| Total, all-cause mortality | Pregabalin 450 mg | ||
| Total, other adverse events | Placebo | 13 | 23 |
| Total, other adverse events | Pregabalin 50 mg | 9 | 22 |
| Total, other adverse events | Pregabalin 100 mg | 12 | 23 |
| Total, other adverse events | Pregabalin 150 mg | 15 | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20466589 | 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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00676403
GET https://conductscience.org/api/trials/v1/NCT00676403/results?page=2