Pramipexole ER vs. Placebo in Fibromyalgia

NCT00689052 | Terminated Phase 2 Results

• 1 other identifier: 248.637
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 42

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  Baseline and Week 29

Secondary Outcomes (12)

• 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

• Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)

  Baseline and Week 29

• Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).

  Baseline and Week 29

Study Arms (2)

Pramipexole ER

EXPERIMENTAL

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

Drug: pramipexole ER

Placebo

PLACEBO COMPARATOR

Placebo tablets, once daily in the evening

Drug: placebo

Interventions

pramipexole ER DRUG

Pramipexole ER

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (42)

248.637.01009 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

248.637.01033 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

248.637.01045 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

248.637.01034 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Location

248.637.01032 Boehringer Ingelheim Investigational Site

Arcadia, California, United States

Location

248.637.01044 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

248.637.01036 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

248.637.01042 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

Location

248.637.01031 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

248.637.01035 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

248.637.01023 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

248.637.01047 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

248.637.01043 Boehringer Ingelheim Investigational Site

Palm Beach Gardens, Florida, United States

Location

248.637.01040 Boehringer Ingelheim Investigational Site

Sunrise, Florida, United States

Location

248.637.01027 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.637.01007 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

248.637.01028 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.637.01010 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

248.637.01016 Boehringer Ingelheim Investigational Site

Newton, Massachusetts, United States

Location

248.637.01014 Boehringer Ingelheim Investigational Site

Lansing, Michigan, United States

Location

248.637.01020 Boehringer Ingelheim Investigational Site

Flowood, Mississippi, United States

Location

248.637.01018 Boehringer Ingelheim Investigational Site

Picayune, Mississippi, United States

Location

248.637.01012 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

248.637.01017 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

248.637.01024 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

248.637.01008 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

248.637.01002 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.637.01025 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

248.637.01026 Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

Location

248.637.01004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

248.637.01038 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

248.637.01003 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

248.637.01046 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

248.637.01006 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

248.637.01039 Boehringer Ingelheim Investigational Site

Duncansville, Pennsylvania, United States

Location

248.637.01015 Boehringer Ingelheim Investigational Site

Warwick, Rhode Island, United States

Location

248.637.01019 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

248.637.01037 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

248.637.01041 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

248.637.01021 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

248.637.01029 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

248.637.01011 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Early termination leading to no number of subjects analysed for any outcome measure

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: June 9, 2014
• Results First Posted: November 25, 2009

Record last verified: 2014-05

Locations

US (42)