Overview

Pramipexole ER vs. Placebo in Fibromyalgia

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Pramipexole
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