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Placebo TID

50 mg TID (150 mg/day)

100 mg TID (300 mg/day)

200 mg TID (600 mg/day)

Secondary Endpoints:

Measures of sleepiness

(ESS; VAS) 

Primary Endpoint:

Subject-rated Pain

(NRS) on Day 14

0 = No Pain, 10 = Worst Possible Pain

Phase 3: RESUME-1 Study 

Subject-Rated Pain Numerical Rating Scale (NRS) on Day 1, 4, 14

Daily electronic patient-reported (ePRO) Assessments and Dosing Diary

Follow-up

Safety and efficacy study

Randomization

SUBJECTS:

#: 1000

Age: 18 to 64 years

RANDOMIZATION:

1:1:1:1:1

Current acute back pain and/or stiffness due to acute and painful muscle spasms

Numerical Rating Scale (NRS) pain of 4 or more at baseline

Study initiated December 2020; topline data expected Q4 2021

Enrollment Criteria:

DAYS

14

4

21

1

Placebo TID

50 mg TID (150 mg/day)

100 mg TID (300 mg/day)

200 mg TID (600 mg/day)

Secondary Endpoints:

Measures of sleepiness

(ESS; VAS) 

Primary Endpoint:

Subject-rated Pain

(NRS) on Day 14

0 = No Pain, 10 = Worst Possible Pain

Phase 3: RESUME-1 Study 

Subject-Rated Pain Numerical Rating Scale (NRS) on Day 1, 4, 14

Daily electronic patient-reported (ePRO) Assessments and Dosing Diary

Follow-up

Safety and efficacy study

Randomization

SUBJECTS:

#: 1000

Age: 18 to 64 years

RANDOMIZATION:

1:1:1:1:1

Current acute back pain and/or stiffness due to acute and painful muscle spasms

Numerical Rating Scale (NRS) pain of 4 or more at baseline

Study initiated December 2020; topline data expected Q4 2021

Enrollment Criteria:

DAYS

14

4

21

1