Trial Outcomes & Findings for Phase 2 Study of TD-9855 to Treat Fibromyalgia (NCT NCT01693692)

NCT ID: NCT01693692

Last Updated: 2022-03-04

Results Overview

Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

392 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2022-03-04

Participant Flow

392 participants were enrolled across 53 study sites in the United States.

392 participants were enrolled, but 9 participants were not treated with the study drug.

Participant milestones

Participant milestones
Measure	Placebo Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
Overall Study STARTED	130	131	131
Overall Study Received Study Drug	128	127	128
Overall Study COMPLETED	100	97	95
Overall Study NOT COMPLETED	30	34	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
Overall Study Withdrawal by Subject	12	10	11
Overall Study Adverse Event	7	14	9
Overall Study Physician Decision	0	0	1
Overall Study Protocol Violation	5	4	6
Overall Study Lost to Follow-up	2	2	3
Overall Study Other	4	4	6

Baseline Characteristics

Phase 2 Study of TD-9855 to Treat Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=130 Participants Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 n=131 Participants Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 n=131 Participants Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	Total n=392 Participants Total of all reporting groups
Age, Continuous	45.8 years n=5 Participants	48.0 years n=7 Participants	43.2 years n=5 Participants	45.7 years n=4 Participants
Age, Customized Age (years) · 18 - 45 Years of Age	55 Participants n=5 Participants	51 Participants n=7 Participants	73 Participants n=5 Participants	179 Participants n=4 Participants
Age, Customized Age (years) · 46 - 65 Years of Age	75 Participants n=5 Participants	80 Participants n=7 Participants	58 Participants n=5 Participants	213 Participants n=4 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	123 Participants n=7 Participants	123 Participants n=5 Participants	369 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	57 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants	115 Participants n=7 Participants	112 Participants n=5 Participants	333 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	51 Participants n=4 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	107 Participants n=7 Participants	107 Participants n=5 Participants	324 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	130 participants n=5 Participants	131 participants n=7 Participants	131 participants n=5 Participants	392 participants n=4 Participants
Weight	81.9 kg STANDARD_DEVIATION 17.64 • n=5 Participants	83.2 kg STANDARD_DEVIATION 17.68 • n=7 Participants	79.0 kg STANDARD_DEVIATION 17.27 • n=5 Participants	81.4 kg STANDARD_DEVIATION 17.57 • n=4 Participants
Height	163.3 cm STANDARD_DEVIATION 6.85 • n=5 Participants	164.5 cm STANDARD_DEVIATION 7.65 • n=7 Participants	164.0 cm STANDARD_DEVIATION 8.49 • n=5 Participants	164.0 cm STANDARD_DEVIATION 7.69 • n=4 Participants
Body Mass Index	30.7 kg/m^2 STANDARD_DEVIATION 6.24 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 5.74 • n=7 Participants	29.3 kg/m^2 STANDARD_DEVIATION 5.59 • n=5 Participants	30.2 kg/m^2 STANDARD_DEVIATION 5.89 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: Only participants with available data were used for this analysis.

Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.

Outcome measures

Outcome measures
Measure	Placebo n=126 Participants Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 n=122 Participants Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 n=125 Participants Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
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 percentage change Standard Error 0.17	-1.2 percentage change Standard Error 0.18	-1.4 percentage change Standard Error 0.17

SECONDARY outcome

Timeframe: Day 43 (End of study treatment)

Population: Only participants with available data were used for this analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=126 Participants Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 n=122 Participants Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 n=125 Participants Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
Fibromyalgia Impact Questionnaire (FIQ)	44.0 score on a scale Standard Deviation 1.75	42.4 score on a scale Standard Deviation 1.75	38.2 score on a scale Standard Deviation 1.75

SECONDARY outcome

Timeframe: Day 43 (End of study treatment)

Population: Only participants with available data were used for this analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=126 Participants Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 n=122 Participants Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 n=125 Participants Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
Patient Global Impression of Change (PGIC)	3.2 score on a scale Standard Error 0.11	2.9 score on a scale Standard Error 0.11	2.8 score on a scale Standard Error 0.11

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

TD-9855 Group 1

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

TD-9855 Group 2

Serious events: 1 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=128 participants at risk Participants will be administered a placebo once daily for 6 weeks.	TD-9855 Group 1 n=127 participants at risk Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	TD-9855 Group 2 n=128 participants at risk Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
Nervous system disorders Transient neurological symptoms of unknown etiology	0.00% 0/128 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.	0.79% 1/127 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.	0.00% 0/128 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.
Cardiac disorders Supraventricular tachycardia	0.00% 0/128 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.	0.00% 0/127 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.	0.78% 1/128 • Day 1 up to Day 63 Only data from participants who received study drug or placebo is included here.

Other adverse events

Additional Information

Medical Monitor

Theravance Biopharma

Phone: 1-855-633-8479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place