Pramipexole ER vs. Placebo in Fibromyalgia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT00689052

Run by

Boehringer Ingelheim

People needed

61

Starts

2008-07-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 248.637.01009 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 248.637.01033 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 248.637.01045 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 248.637.01034 Boehringer Ingelheim Investigational Site — Hot Springs, Arkansas, United States
• 248.637.01032 Boehringer Ingelheim Investigational Site — Arcadia, California, United States
• 248.637.01044 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 248.637.01036 Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• 248.637.01042 Boehringer Ingelheim Investigational Site — Englewood, Colorado, United States
• 248.637.01031 Boehringer Ingelheim Investigational Site — Danbury, Connecticut, United States
• 248.637.01035 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 248.637.01023 Boehringer Ingelheim Investigational Site — Fort Myers, Florida, United States
• 248.637.01047 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 248.637.01043 Boehringer Ingelheim Investigational Site — Palm Beach Gardens, Florida, United States
• 248.637.01040 Boehringer Ingelheim Investigational Site — Sunrise, Florida, United States
• 248.637.01027 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 248.637.01007 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 248.637.01028 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 248.637.01010 Boehringer Ingelheim Investigational Site — Lexington, Kentucky, United States
• 248.637.01016 Boehringer Ingelheim Investigational Site — Newton, Massachusetts, United States
• 248.637.01014 Boehringer Ingelheim Investigational Site — Lansing, Michigan, United States
• 248.637.01020 Boehringer Ingelheim Investigational Site — Flowood, Mississippi, United States
• 248.637.01018 Boehringer Ingelheim Investigational Site — Picayune, Mississippi, United States
• 248.637.01012 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 248.637.01017 Boehringer Ingelheim Investigational Site — Billings, Montana, United States
• 248.637.01024 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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