Trial · NCT00991276
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT00991276, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-10-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance. Trials, record NCT00991276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00991276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
- NCT number
- NCT00991276
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- pregabalin, placebo, pramipexole
- First posted
- 2009-10-07
- Last updated
- 2021-02-15
- Results first posted
- 2012-10-08
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Wake After Sleep Onset (WASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET) | WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep \[WTDS\] epochs + Wake Time After Sleep \[WTAS\] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Periodic Limb Movement Arousal Index (PLMAI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time \[TST\]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Subjective Total Sleep Time (sTST) | Week 3 and Week 5 of Each Intervention Period or ET | sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Minutes of Stage N1, N2, N3 and R Sleep | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM \[Stage N2\] 30-second (30-sec) epoch, Stage 3 Non-REM \[Stage N3\] 30-sec epoch, or stage rapid eye movement \[stage R\] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Restless Legs Syndrome-Next Day Impact (RLS-NDI) | Week 3 and Week 5 of Each Intervention Period or ET | RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Periodic Limb Movement Index (PLMI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Periodic Limb Movement in Sleep Index (PLMSI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. |
| Secondary | Number of Arousals (NASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Wake After Sleep Onset (WASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET) | Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement Arousal Index (PLMAI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Total Sleep Time (sTST) | Week 3 and Week 5 of Each Intervention Period or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Minutes of Stage N1, N2, N3 and R Sleep | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Restless Legs Syndrome-Next Day Impact (RLS-NDI) | Week 3 and Week 5 of Each Intervention Period or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement Index (PLMI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement in Sleep Index (PLMSI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Arousals (NASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | arousals | LEAST_SQUARES_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group324
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Wake After Sleep Onset (WASO) | Pregabalin 300 mg | 51.50 | 95% Confidence Interval 43.20 to 59.79 | minutes | |
| Wake After Sleep Onset (WASO) | Pramipexole 0.5 mg | 78.42 | 95% Confidence Interval 70.34 to 86.51 | minutes | |
| Wake After Sleep Onset (WASO) | Placebo | 78.60 | 95% Confidence Interval 70.29 to 86.90 | minutes | |
| Periodic Limb Movement Arousal Index (PLMAI) | Pregabalin 300 mg | 3.93 | 95% Confidence Interval 2.49 to 5.36 | movement/hour | |
| Periodic Limb Movement Arousal Index (PLMAI) | Pramipexole 0.5 mg | 2.66 | 95% Confidence Interval 1.27 to 4.06 | movement/hour | |
| Periodic Limb Movement Arousal Index (PLMAI) | Placebo | 7.61 | 95% Confidence Interval 6.17 to 9.04 | movement/hour | |
| Subjective Total Sleep Time (sTST) | Pregabalin 300 mg | 400.97 | 95% Confidence Interval 386.36 to 415.58 | minutes | |
| Subjective Total Sleep Time (sTST) | Pramipexole 0.5 mg | 374.19 | 95% Confidence Interval 360.00 to 388.37 | minutes | |
| Subjective Total Sleep Time (sTST) | Placebo | 370.16 | 95% Confidence Interval 355.69 to 384.63 | minutes | |
| Minutes of Stage N1, N2, N3 and R Sleep | Pregabalin 300 mg | Stage N1 Sleep | 38.06 | 95% Confidence Interval 32.97 to 43.14 | minutes |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period | STARTED | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | 15 | |
| First Intervention Period | STARTED | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | 13 | |
| First Intervention Period | STARTED | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | 14 | |
| First Intervention Period | STARTED | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | 15 | |
| First Intervention Period | STARTED | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | 15 | |
| First Intervention Period | STARTED | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg | 13 | |
| First Intervention Period | COMPLETED | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | 15 | |
| First Intervention Period | COMPLETED | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | 10 | |
| First Intervention Period | COMPLETED | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | 14 | |
| First Intervention Period | COMPLETED | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | 11 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events366
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 | Anaemia | Blood and lymphatic system disorders | Pregabalin 300 mg | 0 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | Pramipexole 0.5 mg | 0 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 73 | |
| other | Ventricular tachycardia | Cardiac disorders | Pregabalin 300 mg | 0 | 75 | |
| other | Ventricular tachycardia | Cardiac disorders | Pramipexole 0.5 mg | 0 | 76 | |
| other | Ventricular tachycardia | Cardiac disorders | Placebo | 1 | 73 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 300 mg | 1 | 75 | |
| other | Vertigo | Ear and labyrinth disorders | Pramipexole 0.5 mg | 0 | 76 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 73 | |
| other | Diplopia | Eye disorders | Pregabalin 300 mg | 1 | 75 |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 adverse eventsAdverse event totals9
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 0.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin 300 mg | 46 | 75 |
| Total, other adverse events | Pramipexole 0.5 mg | 40 | 76 |
| Total, other adverse events | Placebo | 27 | 73 |
| Total, serious adverse events | Pregabalin 300 mg | 2 | 75 |
| Total, serious adverse events | Pramipexole 0.5 mg | 1 | 76 |
| Total, serious adverse events | Placebo | 3 | 73 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24899755 | 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/NCT00991276
GET https://conductscience.org/api/trials/v1/NCT00991276/registered?page=2