Pramipexole ER vs. Placebo in Fibromyalgia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00689052
First received: May 29, 2008
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: pramipexole ER
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The Change in the Weekly Mean of the 24 Hour Average Pain Score From a Daily Diary [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Measured by the 11 point Likert scale with 0 = no pain and 10 = worst possible pain (assessed between baseline and the end of maintenance phase).


Enrollment: 61
Study Start Date: July 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pramipexole ER
0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
Drug: pramipexole ER
Placebo Comparator: Placebo
Placebo tablets, once daily in the evening
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689052

  Show 42 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00689052     History of Changes
Other Study ID Numbers: 248.637
Study First Received: May 29, 2008
Results First Received: October 23, 2009
Last Updated: December 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 17, 2014