Phase 2
Completed N=392
Phase 2 Study of TD-9855 to Treat Fibromyalgia
Source: ClinicalTrials.gov NCT01693692 ↗Enrolled (actual)
392
Serious AEs
0.5%
Results posted
Mar 2022
Primary outcomePrimary: Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries — -0.9; -1.2; -1.4 percentage change — p=0.1683
Summary
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries |
-0.9; -1.2; -1.4 | 0.1683 |
| SECONDARY Fibromyalgia Impact Questionnaire (FIQ) |
44.0; 42.4; 38.2 | 0.2637 |
| SECONDARY Patient Global Impression of Change (PGIC) |
3.2; 2.9; 2.8 | 0.0639 |
Eligibility Criteria
Inclusion Criteria
- • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
- Informed consent
- 18 to 65 years of age
- Discontinue therapy with adrenergic-acting drugs, and certain other medications
- Only acetaminophen or NSAID as rescue pain medication
- No narcotic pain meds or benzodiazepines
- Only non-benzodiazepines as rescue hypnotics
Exclusion Criteria
- Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
- Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
- Risk of suicide (investigator opinion and/or C-SSRS)
- Recent history of substance or alcohol abuse
- BMI <18 or ≥45
- Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
- Abnormal lab values (liver, kidney, thyroid, and others)
Data sourced from ClinicalTrials.gov (NCT01693692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.