Pregabalin (Lyrica) for the Treatment of Restless Legs Sy... | NCT00584246

Studies
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

NCT00584246

Sponsor

University of South Florida

Status

Withdrawn

Last Update Posted

Nov 16, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Restless Legs Syndrome

Interventions

Pregabalin (Lyrica)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
105362

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped due to budget (personnel) limitations.

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Pregabalin (Lyrica)	Drug: Pregabalin (Lyrica)
2	Placebo Comparator	Placebo	Drug: Pregabalin (Lyrica) Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin (Lyrica)	Drug	50 - 150 mg po qhs for 2 months	1 2

Measure	Description	Time Frame
International RLS Study Group Severity Scale (IRLS)		2 months

Measure	Description	Time Frame
Clinical Global Impression (CGI)		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
Patients must report some degree of pain which occurs on a regular basis.
Age 18 years to 80 years.
Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
Willing and able to provide informed consent.
Willing to comply with protocol. -

Exclusion Criteria:

Any illness that in the investigator's opinion preclude participation in this study.
Pregnancy or lactation.
Concurrent participation in another clinical study.
Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
Legal incapacity or limited legal capacity.
Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
Presence of severe daytime sleepiness.
Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
Patients taking dopamine agonists for any condition other than RLS. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic