Phase 3
Completed N=327
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
Source: ClinicalTrials.gov NCT00311363 ↗Enrolled (actual)
327
Serious AEs
1.2%
Results posted
May 2011
Primary outcomePrimary: Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period — 22.7; 9.4 percentage of participants — p=0.0158
Summary
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period |
22.7; 9.4 | 0.0158 sig |
| SECONDARY Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period |
— | — |
| SECONDARY Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase) |
— | — |
| SECONDARY Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) |
5.3; 5.1; 9.2; 7.0; 3.9; 1.9 | — |
| SECONDARY Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF |
67; 75 | — |
| SECONDARY Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF |
4; 10; 5; 3; 12; 15 | — |
| SECONDARY Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF |
47; 60; 30; 24; 7; 4 | — |
| SECONDARY Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF |
79.4; 87.5 | — |
| SECONDARY Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF |
11.8; 11.0; 15.5; 12.6; 3.8; 1.5 | — |
| SECONDARY Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF |
16.7; 18.8; 26.9; 21.0; 10.2; 2.3 | — |
| SECONDARY Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF |
73.3; 74.6; 61.6; 70.3; -11.6; -4.3 | — |
| SECONDARY Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF |
7.0; 7.0; 6.8; 6.9; -0.2; -0.1 | — |
| SECONDARY Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score |
94.1; 94.3; 89.9; 92.1; -4.2; -2.2 | — |
| SECONDARY Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) |
83; 88; 72; 83; 85; 85 | — |
| SECONDARY Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase) |
14.5 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF |
38; 43; 56; 46; 3; 7 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF |
53; 63; 42; 28; 2; 4 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF |
47; 38; 35; 36; 8; 11 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF |
73; 72; 22; 22; 2; 1 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF |
73; 72; 14; 16; 7; 5 | — |
| SECONDARY Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF |
24.7; 9.2; -15.5 | — |
| SECONDARY Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF |
170; 78; 28; 25; 4; 4 | — |
| SECONDARY Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF |
163; 82; 38; 16; 7; 0 | — |
| SECONDARY Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF |
-21.8 | — |
| SECONDARY Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF |
-35.3 | — |
| SECONDARY Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF |
35.7 | — |
| SECONDARY Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF |
1.0 | — |
| SECONDARY Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase) |
25.7 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF |
3; 97; 211; 102; 164; 45 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF |
20; 124; 141; 26; 145; 127 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF |
1; 1; 36; 122; 151; 106 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF |
26; 131; 113; 41; 188; 98 | — |
| SECONDARY Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF |
26; 78; 107; 60; 40; 188 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
Exclusion Criteria
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
Data sourced from ClinicalTrials.gov (NCT00311363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.