Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00806026

Purpose

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Condition	Intervention	Phase
Idiopathic Restless Legs Syndrome	Drug: placebo and pregabalin Drug: pramipexol Drug: Pregabalin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs

Drug Information available for: Pramipexol Pregabalin Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

RLS symptom severity using International RLS Severity Scale (IRLS) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Proportion of subjects responding to treatment using Clinical Global Impression - Improvement (CGI-I) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Rate of augmentation [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Subjective Sleep Questionnaire (SSQ) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
RLS Quality of Life (RLS-QoL) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Augmentation Severity Rating Scale (ASRS) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Clinical Global Impression - Severity (CGI-S) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Medical Outcomes Study - Sleep Scale (MOS-SS) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Profile of Mood States (POMS) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Daytime Function - Patient Reported Outcome (DF-PRO) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Limb Pain - Numeriacl Rating Scale (Limb Pain - NRS) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	731
Study Start Date:	December 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PBO/PGB 300 mg	Drug: placebo and pregabalin following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime. Other Name: Lyrica
Active Comparator: PBO/PPX 0.25 mg	Drug: pramipexol following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. Other Name: Mirapex
Active Comparator: PBO/PPX 0.5 mg	Drug: pramipexol following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. Other Name: Mirapex
Experimental: PGB 300 mg	Drug: Pregabalin pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months Other Name: Lyrica
Active Comparator: PPX 0.25 mg	Drug: pramipexol pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months Other Name: Mirapex
Active Comparator: PPX 0.5 mg	Drug: pramipexol pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months Other Name: Mirapex

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

idiopathic RLS with the presence of all four clinical manifestations of RLS
RLS symptoms occur predominantly in the evening
RLS history at least 6 months
IRLS => 15 at the beginning and the end of placebo run-in
Have =>15 nights with RLS symptoms in the month prior to screening

Exclusion Criteria:

Any secondary RLS
Current augmentation due to RLS treatment
Placebo responders identified during the placebo run-in

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806026

Show 110 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00806026 History of Changes
Other Study ID Numbers:	A0081186
Study First Received:	December 9, 2008
Last Updated:	May 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

RLS

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Pramipexol
Pregabalin

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012