Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cyclobenzaprine · 1 trial · 3 indications
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
| Arm | Type | Description |
|---|---|---|
| Cyclobenzaprine HCl 15 mg | EXPERIMENTAL | Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. |
| Placebo | PLACEBO_COMPARATOR | Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| Cyclobenzaprine HCl | DRUG | Cyclobenzaprine HCl extended-release capsules |
| Placebo | DRUG | Cyclobenzaprine HCl extended release placebo-matching capsules |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is experien...
Cyclobenzaprine is a small molecule used for the treatment of neck pain, as well as back pain and muscle spasms of local origin. It is being studied in an extended release 15 mg formulation for these conditions.
Cyclobenzaprine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK.
Cyclobenzaprine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA.
Cyclobenzaprine is being studied in a Phase 3 clinical trial with the identifier NCT02814565. This trial is a randomized, double-blind, placebo-controlled study of cyclobenzaprine HCl extended release 15 mg versus placebo in the treatment of cervical and/or lower back pain due to muscle spasms of local origin.
Cyclobenzaprine HCl extended release is a formulation of cyclobenzaprine. The drug is being studied in this extended release form at a 15 mg dose.