Clinical trial NCT00689052: Pramipexole ER vs. Placebo in Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male and female outpatients greater than or equal to 18 years of age
2. 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)
3. 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
4. Score of greater than or equal to 4 (= moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and at baseline
5. 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
6. Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator
7. Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol

Exclusion Criteria:

1. Employees of Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study)
2. Have received treatment within 30 days prior to screening with a drug that has not received regulatory approval for any indication
3. Have previously completed or withdrawn from this study or any other study investigating pramipexole.
4. Any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
5. Have any primary anxiety disorder within the past year as assessed by the Mini International Neuropsychiatric Interview (MINI)
6. Have any Diagnosis of Statistical Manual of Mental Diseases, 4th Edition (DSM-IV) Axis II disorder that would interfere with protocol compliance
7. Medium or high risk of suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI)
8. History of substance abuse/dependence within the past year, excluding nicotine and caffeine
9. A positive urine drug screen for any substance of abuse or excluded medication
10. Women who are pregnant or breast-feeding
11. Have pain symptoms related to traumatic injury that will interfere with the interpretation of outcome measures
12. Patients with regional pain syndromes, multiple surgeries or failed back surgery syndrome
13. A confirmed or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease
14. Abnormal C-Reactive Protein, Anti-Nuclear Antibody (ANA), Rheumatoid factor, or Thyroid Stimulating Hormone (TSH)
15. 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
16. Have uncontrolled seizures
17. Taking any prohibited medications that cannot be discontinued at screening
18. Patients who are treatment-refractory or whose response may be compromised by disability compensation issues
19. Patients with frequent or severe allergic reactions to multiple medications
20. Prior or current treatment with pramipexole
21. Clinically significant renal disease
22. Current or previous diagnosis of malignant melanoma
23. Clinically relevant ophthalmopathy
24. Documented sleep apnea

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 29
Secondary outcomes:
measure: The Proportion of Patients "Very Much Improved" or "Much Improved" on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale
timeFrame: Week 29 (at the end of the maintenance phase)
measure: The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).
timeFrame: Baseline and Week 29
measure: 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
timeFrame: Baseline and Week 29
measure: Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)
timeFrame: Baseline and Week 29
measure: Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).
timeFrame: Baseline and Week 29
measure: The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).
timeFrame: Baseline and Week 29
measure: Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)
timeFrame: Baseline and Week 29
measure: Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)
timeFrame: Baseline and Week 29
measure: Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)
timeFrame: Baseline and Week 29
measure: Clinical Global Impression of Severity (CGI-S Scores)
timeFrame: Baseline and Week 29
measure: Frequency of Rescue Medication for Pain
timeFrame: Week 29
measure: Change From Baseline in Mean Tender Point Threshold
timeFrame: Baseline and Week 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 248.637.01009 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 248.637.01033 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 248.637.01045 Boehringer Ingelheim Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: 248.637.01034 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Arcadia
country: United States
facility: 248.637.01032 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 248.637.01044 Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: 248.637.01036 Boehringer Ingelheim Investigational Site
state: California
city: Englewood
country: United States
facility: 248.637.01042 Boehringer Ingelheim Investigational Site
state: Colorado
city: Danbury
country: United States
facility: 248.637.01031 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Deland
country: United States
facility: 248.637.01035 Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Myers
country: United States
facility: 248.637.01023 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 248.637.01047 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: 248.637.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: Sunrise
country: United States
facility: 248.637.01040 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.637.01027 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 248.637.01007 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 248.637.01028 Boehringer Ingelheim Investigational Site
state: Illinois
city: Lexington
country: United States
facility: 248.637.01010 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Newton
country: United States
facility: 248.637.01016 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: 248.637.01014 Boehringer Ingelheim Investigational Site
state: Michigan
city: Flowood
country: United States
facility: 248.637.01020 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Picayune
country: United States
facility: 248.637.01018 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: 248.637.01012 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 248.637.01017 Boehringer Ingelheim Investigational Site
state: Montana
city: Albuquerque
country: United States
facility: 248.637.01024 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Albany
country: United States
facility: 248.637.01008 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.637.01002 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 248.637.01025 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: 248.637.01026 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: 248.637.01004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 248.637.01038 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 248.637.01003 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 248.637.01046 Boehringer Ingelheim Investigational Site
state: Oregon
city: Portland
country: United States
facility: 248.637.01006 Boehringer Ingelheim Investigational Site
state: Oregon
city: Duncansville
country: United States
facility: 248.637.01039 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: 248.637.01015 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Austin
country: United States
facility: 248.637.01019 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 248.637.01037 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 248.637.01041 Boehringer Ingelheim Investigational Site
state: Utah
city: Renton
country: United States
facility: 248.637.01021 Boehringer Ingelheim Investigational Site
state: Washington
city: Seattle
country: United States
facility: 248.637.01029 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 248.637.01011 Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: