A Randomized, Double-blind, Placebo-controlled, Dose Titration Efficacy and Safety Study of Pramipexole ER (0.75 to 4.5 mg) Administered Orally Once Daily Versus Placebo Over a 16-week Maintenance Phase in Patients Diagnosed With Fibromyalgia, as Assessed by the American College of Rheumatology (ACR) Criteria Followed by a 24-week Open-label Extension Phase

Boehringer Ingelheim42 sites in 1 country61 target enrollmentJuly 2008

ConditionsFibromyalgia

Interventionspramipexole ER placebo

Drugspramipexole ER placebo

Overview

Phase: Phase 2
Intervention: pramipexole ER
Conditions: Fibromyalgia
Sponsor: Boehringer Ingelheim
Enrollment: 61
Locations: 42
Primary Endpoint: The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.

The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

November 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female outpatients greater than or equal to 18 years of age
•Meet criteria for primary fibromyalgia as defined by the American College of Rheumatology (ACR): widespread aching pain in all four quadrants of the body and axial skeleton for greater than 3 months duration and greater than or equal to 11 of 18 tender points under digital palpitation examination with an approximate force of 4 kilograms per centimeters squared (kg/cm2)
•Pain score of greater than or equal to 4 (scored once at screening and as a weekly mean at baseline) on the 11-point Likert pain scale with 0 = no pain and 10 = worst possible pain
•Score of greater than or equal to 4 (= moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and at baseline
•All females of child-bearing potential must test negative for pregnancy at Visit
•Females of child-bearing potential (not surgically sterilized and between menarche and two years postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for one month following the last dose of study medication. Examples of reliable methods include: use of hormonal contraception (oral, injectable, or subcutaneous), double-barrier method, abstinence, partner with vasectomy, or hormonal intrauterine devices
•Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator
•Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol

Exclusion Criteria

•Employees of Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study)
•Have received treatment within 30 days prior to screening with a drug that has not received regulatory approval for any indication
•Have previously completed or withdrawn from this study or any other study investigating pramipexole.
•Any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
•Have any primary anxiety disorder within the past year as assessed by the Mini International Neuropsychiatric Interview (MINI)
•Have any Diagnosis of Statistical Manual of Mental Diseases, 4th Edition (DSM-IV) Axis II disorder that would interfere with protocol compliance
•Medium or high risk of suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI)
•History of substance abuse/dependence within the past year, excluding nicotine and caffeine
•A positive urine drug screen for any substance of abuse or excluded medication
•Women who are pregnant or breast-feeding

Arms & Interventions

Pramipexole ER

0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening

Intervention: pramipexole ER

Placebo

Placebo tablets, once daily in the evening

Intervention: placebo

Outcomes

Primary Outcomes

The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale

Time Frame: Baseline and Week 29

The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)

Secondary Outcomes

Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)(Baseline and Week 29)
The Proportion of Patients "Very Much Improved" or "Much Improved" on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale(Week 29 (at the end of the maintenance phase))
The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).(Baseline and Week 29)
The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale(Baseline and Week 29)
Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).(Baseline and Week 29)
The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).(Baseline and Week 29)
Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)(Baseline and Week 29)
Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)(Baseline and Week 29)
Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)(Baseline and Week 29)
Clinical Global Impression of Severity (CGI-S Scores)(Baseline and Week 29)
Frequency of Rescue Medication for Pain(Week 29)
Change From Baseline in Mean Tender Point Threshold(Baseline and Week 29)