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Also known as BIIB074
CNV1014802 · 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...
CNV1014802 is an investigational small molecule being developed by Biogen Inc. (ticker BIIB) for neurological pain conditions. It has been studied in lumbosacral radiculopathy and trigeminal neuralgia. It is in Phase 2 development and has not been approved by the FDA.
CNV1014802 has been studied for two neuropathic pain indications: lumbosacral radiculopathy, which is nerve root pain in the lower back, and trigeminal neuralgia, a chronic facial pain condition. Both are neurology indications. The drug remains investigational and is not approved for any use.
CNV1014802 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor behind the clinical program studying the drug in neuropathic pain conditions including lumbosacral radiculopathy and trigeminal neuralgia.
CNV1014802 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in lumbosacral radiculopathy and one in trigeminal neuralgia, along with a Phase 1 pharmacokinetic and tolerability study. No active trials are currently listed for this drug.
CNV1014802 has been evaluated in three completed trials. NCT01561027 was a Phase 2 crossover study in lumbosacral radiculopathy across Czechia, Denmark, France, and Sweden. NCT01540630 was a Phase 2a withdrawal study in trigeminal neuralgia in the United Kingdom. NCT02359344 was a Phase 1 pharmacokinetic and tolerability study in healthy volunteers.
Across its clinical program, CNV1014802 trials enrolled a total of 181 participants. The Phase 2 lumbosacral radiculopathy study NCT01561027 enrolled 82 patients, the Phase 2a trigeminal neuralgia withdrawal study NCT01540630 enrolled 67 patients, and the Phase 1 study NCT02359344 enrolled 32 healthy volunteers.