Phase 2 Study of TD-9855 to Treat Fibromyalgia
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ClinicalTrials.gov Identifier: NCT01693692 |
Recruitment Status :
Completed
First Posted : September 26, 2012
Results First Posted : March 4, 2022
Last Update Posted : March 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Drug: TD-9855 Group 1 Drug: TD-9855 Group 2 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 392 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM) |
Actual Study Start Date : | November 2012 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: TD-9855 Group 1
Group 1 to be dosed with TD-9855
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Drug: TD-9855 Group 1 |
Experimental: TD-9855 Group 2
Group 2 to be dosed with TD-9855
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Drug: TD-9855 Group 2 |
Placebo Comparator: Placebo
Group to be dosed with Placebo
|
Drug: Placebo |
- 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 [ Time Frame: Baseline and Week 6 ]Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
- Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Day 43 (End of study treatment) ]FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.
- Patient Global Impression of Change (PGIC) [ Time Frame: Day 43 (End of study treatment) ]PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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• American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
- Informed consent
- 18 to 65 years of age
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693692

Study Director: | Medical Monitor | Theravance Biopharma |
Responsible Party: | Theravance Biopharma |
ClinicalTrials.gov Identifier: | NCT01693692 |
Other Study ID Numbers: |
0092 |
First Posted: | September 26, 2012 Key Record Dates |
Results First Posted: | March 4, 2022 |
Last Update Posted: | March 4, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Fibromyalgia |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |