Pramipexole ER vs. Placebo in Fibromyalgia

Phase 2

Terminated

Conditions: Fibromyalgia

Interventions: Drug: pramipexole ER
Drug: placebo

Registration Number: NCT00689052

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 61

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 1. 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
Have pain symptoms related to traumatic injury that will interfere with the interpretation of outcome measures
Patients with regional pain syndromes, multiple surgeries or failed back surgery syndrome
A confirmed or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease
Abnormal C-Reactive Protein, Anti-Nuclear Antibody (ANA), Rheumatoid factor, or Thyroid Stimulating Hormone (TSH)
Any serious or unstable medical or psychiatric condition or clinically significant abnormalities in labs at screening that would lead to hospitalization during the course of the study or otherwise compromise study participation
Have uncontrolled seizures
Taking any prohibited medications that cannot be discontinued at screening
Patients who are treatment-refractory or whose response may be compromised by disability compensation issues
Patients with frequent or severe allergic reactions to multiple medications
Prior or current treatment with pramipexole
Clinically significant renal disease
Current or previous diagnosis of malignant melanoma
Clinically relevant ophthalmopathy
Documented sleep apnea

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pramipexole ER	pramipexole ER	0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
Placebo	placebo	Placebo tablets, once daily in the evening

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)	Baseline and Week 29	FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week. The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact
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)	PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment. The score ranges from 1 = very much improved to 7 = very much worse
The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).	Baseline and Week 29	The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
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	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 .
Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).	Baseline and Week 29	The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms
The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).	Baseline and Week 29	The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)	Baseline and Week 29	The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.
Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)	Baseline and Week 29	The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .
Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)	Baseline and Week 29	The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.
Clinical Global Impression of Severity (CGI-S Scores)	Baseline and Week 29	Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Frequency of Rescue Medication for Pain	Week 29	Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.
Change From Baseline in Mean Tender Point Threshold	Baseline and Week 29	The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (\>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.

Trial Locations

Locations (42): 248.637.01044 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
248.637.01046 Boehringer Ingelheim Investigational Site
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Medford, Oregon, United States
248.637.01007 Boehringer Ingelheim Investigational Site
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Atlanta, Georgia, United States
248.637.01036 Boehringer Ingelheim Investigational Site
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Santa Ana, California, United States
248.637.01028 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
248.637.01008 Boehringer Ingelheim Investigational Site
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Albany, New York, United States
248.637.01004 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
248.637.01021 Boehringer Ingelheim Investigational Site
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Renton, Washington, United States
248.637.01029 Boehringer Ingelheim Investigational Site
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Seattle, Washington, United States
248.637.01026 Boehringer Ingelheim Investigational Site
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Fargo, North Dakota, United States
248.637.01042 Boehringer Ingelheim Investigational Site
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Englewood, Colorado, United States
248.637.01031 Boehringer Ingelheim Investigational Site
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Danbury, Connecticut, United States
248.637.01034 Boehringer Ingelheim Investigational Site
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Hot Springs, Arkansas, United States
248.637.01020 Boehringer Ingelheim Investigational Site
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Flowood, Mississippi, United States
248.637.01014 Boehringer Ingelheim Investigational Site
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Lansing, Michigan, United States
248.637.01035 Boehringer Ingelheim Investigational Site
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Deland, Florida, United States
248.637.01016 Boehringer Ingelheim Investigational Site
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Newton, Massachusetts, United States
248.637.01017 Boehringer Ingelheim Investigational Site
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Billings, Montana, United States
248.637.01023 Boehringer Ingelheim Investigational Site
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Ft. Myers, Florida, United States
248.637.01045 Boehringer Ingelheim Investigational Site
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Tucson, Arizona, United States
248.637.01015 Boehringer Ingelheim Investigational Site
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Warwick, Rhode Island, United States
248.637.01025 Boehringer Ingelheim Investigational Site
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Charlotte, North Carolina, United States
248.637.01002 Boehringer Ingelheim Investigational Site
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New York, New York, United States
248.637.01011 Boehringer Ingelheim Investigational Site
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Spokane, Washington, United States
248.637.01038 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
248.637.01032 Boehringer Ingelheim Investigational Site
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Arcadia, California, United States
248.637.01043 Boehringer Ingelheim Investigational Site
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Palm Beach Gardens, Florida, United States
248.637.01040 Boehringer Ingelheim Investigational Site
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Sunrise, Florida, United States
248.637.01018 Boehringer Ingelheim Investigational Site
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Picayune, Mississippi, United States
248.637.01039 Boehringer Ingelheim Investigational Site
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Duncansville, Pennsylvania, United States
248.637.01033 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
248.637.01009 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
248.637.01047 Boehringer Ingelheim Investigational Site
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Orlando, Florida, United States
248.637.01027 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
248.637.01010 Boehringer Ingelheim Investigational Site
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Lexington, Kentucky, United States
248.637.01012 Boehringer Ingelheim Investigational Site
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Kansas City, Missouri, United States
248.637.01003 Boehringer Ingelheim Investigational Site
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Oklahoma City, Oklahoma, United States
248.637.01019 Boehringer Ingelheim Investigational Site
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Austin, Texas, United States
248.637.01037 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
248.637.01041 Boehringer Ingelheim Investigational Site
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Salt Lake City, Utah, United States
248.637.01006 Boehringer Ingelheim Investigational Site
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Portland, Oregon, United States
248.637.01024 Boehringer Ingelheim Investigational Site
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Albuquerque, New Mexico, United States