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Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676403
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : February 4, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Restless Legs Syndrome
Interventions: Drug: placebo
Drug: Pregabalin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects meeting entry criteria with a confirmed diagnosis of Restless Leg Syndrome completed a washout of medications if needed prior to starting a 7-day single-blind placebo run-in to identify and exclude placebo responders and to adapt subjects to take study drug 1-3 hours prior to bedtime. Of 218 subjects screened, 137 subjects entered.

Reporting Groups
  Description
Placebo Single daily oral dose.
Pregabalin 50 mg Single daily 50 mg oral dose.
Pregabalin 100 mg Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Pregabalin 150 mg Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Pregabalin 300 mg Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Pregabalin 450 mg Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).

Participant Flow:   Overall Study
    Placebo   Pregabalin 50 mg   Pregabalin 100 mg   Pregabalin 150 mg   Pregabalin 300 mg   Pregabalin 450 mg
STARTED   23   22   23   22   24   23 
COMPLETED   21   20   22   17   23   18 
NOT COMPLETED   2   2   1   5   1   5 
Adverse Event                1                2                0                5                1                2 
Lost to Follow-up                0                0                0                0                0                1 
Reason Unspecified                1                0                1                0                0                1 
Withdrawal by Subject                0                0                0                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Single daily oral dose.
Pregabalin 50 mg Single daily 50 mg oral dose.
Pregabalin 100 mg Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Pregabalin 150 mg Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Pregabalin 300 mg Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Pregabalin 450 mg Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Total Total of all reporting groups

Baseline Measures
   Placebo   Pregabalin 50 mg   Pregabalin 100 mg   Pregabalin 150 mg   Pregabalin 300 mg   Pregabalin 450 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   23   22   24   23   137 
Age, Customized 
[Units: Participants]
             
18 - 44 years   4   5   7   2   9   3   30 
45 - 64 years   19   15   16   20   15   19   104 
>=65 years   0   2   0   0   0   1   3 
Gender 
[Units: Participants]
             
Female   13   13   16   13   19   16   90 
Male   10   9   7   9   5   7   47 


  Outcome Measures

1.  Primary:   Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6   [ Time Frame: Baseline, Week 6 ]

2.  Secondary:   Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)   [ Time Frame: Week 6 ]

3.  Secondary:   Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF) ]

4.  Secondary:   Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]

5.  Secondary:   Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]

6.  Secondary:   Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]

7.  Secondary:   Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]

8.  Secondary:   Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]

9.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

10.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

11.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

12.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

13.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline   [ Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6 ]

14.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline   [ Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6 ]

15.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

16.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]

17.  Secondary:   Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week   [ Time Frame: Week 1, Week 2, Week 4, Week 6 ]

18.  Secondary:   Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6   [ Time Frame: Baseline, Week 6 ]

19.  Secondary:   Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6   [ Time Frame: Baseline, Week 6 ]

20.  Secondary:   Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores   [ Time Frame: Baseline, Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00676403     History of Changes
Other Study ID Numbers: A0081183
First Submitted: May 8, 2008
First Posted: May 13, 2008
Results First Submitted: January 8, 2010
Results First Posted: February 4, 2010
Last Update Posted: July 7, 2010