Phase 2 Study of TD-9855 to Treat Fibromyalgia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01693692 |
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Recruitment Status :
Completed
First Posted : September 26, 2012
Results First Posted : March 4, 2022
Last Update Posted : March 4, 2022
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Sponsor:
Theravance Biopharma
Information provided by (Responsible Party):
Theravance Biopharma
- Study Details
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Brief Summary:
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Fibromyalgia
MedlinePlus related topics:
Fibromyalgia
| Arm | Intervention/treatment |
|---|---|
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Experimental: TD-9855 Group 1
Group 1 to be dosed with TD-9855
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Drug: TD-9855 Group 1 |
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Experimental: TD-9855 Group 2
Group 2 to be dosed with TD-9855
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Drug: TD-9855 Group 2 |
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Placebo Comparator: Placebo
Group to be dosed with Placebo
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Drug: Placebo |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Information from the National Library of Medicine
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
Locations
Show 34 study locations
Sponsors and Collaborators
Theravance Biopharma
Investigators
| Study Director: | Medical Monitor | Theravance Biopharma |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Theravance Biopharma:
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Fibromyalgia |
Additional relevant MeSH terms:
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |