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Also known as CNV1014802
BIIB074 · 10 trials · 7 indications
Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=pain as bad as you can imagine.
11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess EM paroxysmal pain. PI-NRS is an 11-point pain intensity numerical rating scale, where 0=no pain and 10=worst possible pain. Weekly average is defined as the total of severity scores during a week divided by the total number of paroxysms during that week.
Patients will be classified as a treatment failure if they meet one of the following criteria: * 50% increase in the frequency of paroxysms compared to the final 7 days of the open-label period * 50% increase in the severity of pain experienced in the paroxysms compared to the final 7 days of the open-label period * A Patient Global Improvement of Change rating of much worse/very much worse * The patient discontinues the study due to 'Lack of Efficacy'. v. The patient discontinues due to an adverse reaction or poor tolerability considered to be related to study medication
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
| Arm | Type | Description |
|---|---|---|
| BIIB074 high dose | EXPERIMENTAL | Administered twice daily (BID) |
| BIIB074 low dose | EXPERIMENTAL | Administered BID |
| Placebo | PLACEBO_COMPARATOR | Placebo administered BID |
| Randomized Group 1 | EXPERIMENTAL | After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period |
| Randomized Group 2 | EXPERIMENTAL | After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period |
| CNV1014802 | EXPERIMENTAL | - |
| BIIB074 150 mg and Oral Contraceptive | EXPERIMENTAL | Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32. |
| BIIB074 150 mg and Valproic Acid 500 mg | EXPERIMENTAL | Participants will receive BIIB074 in tablet form in 150 mg doses. BIIB074 will be taken once daily (QD) on Days 1-16 after an 8-hour fast. Valproic Acid will be given in capsule form in 500 mg doses on prescription (TID) every 8 hours on Days 8-22. The morning dose on Day 16 will be coadministered with BIIB074 following an 8-hour fast. |
| Part 1 | EXPERIMENTAL | 48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio |
| Part 2 | EXPERIMENTAL | 16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily \[TID\] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily \[BID\] in cohort 5 for 6 days and QD for 1 day |
| BIIB074 | EXPERIMENTAL | Single oral dose on Day 1 |
| Name | Type | Description |
|---|---|---|
| BIIB074 | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Matched placebo |
| CNV1014802 | DRUG | CNV1014802 150mg tid for 28 days. Dose may be increased to 350mg bid following interim evaluation of efficacy. |
| OC (ethinyl estradiol and levonorgestrel) | DRUG | OC is administered as specified in the treatment arm. |
| Valproic Acid | DRUG | Administered as specified in the treatment arm |
| Itraconazole | DRUG | 200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive |
Key Inclusion Criteria: * Has body weight ≥50 kg for men and ≥45 kg for women * Must have diagnosis of neuropathic PLSR * Has duration of neuropathic (leg) pain of at least 6 months before Screening * Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Scr...
BIIB074 is an investigational small molecule developed by Biogen Inc. (ticker BIIB). It has been studied in clinical trials for neuropathic pain from lumbosacral radiculopathy, primary inherited erythromelalgia, trigeminal neuralgia, and drug interaction assessments. It remains in clinical development and is not described as approved.
BIIB074 was evaluated for treating neuropathic pain from lumbosacral radiculopathy in a completed Phase 2 study, NCT02935608, which enrolled 502 participants across multiple European countries. The trial has finished, and BIIB074 is an investigational therapy, not an approved treatment for this condition.
BIIB074 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen sponsored the clinical trials studying BIIB074 in neuropathic pain, primary inherited erythromelalgia, and drug interaction settings.
BIIB074 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 studies examined drug interactions, while Phase 2 studies evaluated neuropathic pain from lumbosacral radiculopathy and primary inherited erythromelalgia. No active trials are listed, and BIIB074 is investigational rather than approved.
BIIB074 has been studied in completed trials including NCT03385525, a Phase 1 drug interaction study with valproic acid; NCT03324685, a Phase 1 drug interaction study with an oral contraceptive regimen; NCT02935608, a Phase 2 study in lumbosacral radiculopathy; and NCT02917187, a Phase 2a study in primary inherited erythromelalgia.
BIIB074 is the designation used by Biogen Inc. for this investigational small molecule. The trials listed refer to the compound as BIIB074, and no other names are used in the study records.