AbbVie posts TEMPLE Phase 3 results for atogepant vs topiramate; opens three early-stage trials

AbbVie's week included one completed Phase 3 trial with newly posted results and three actively recruiting early-stage studies, plus a terminated outside collaboration.

• The "TEMPLE" trial (NCT05748483) compared oral atogepant against oral topiramate in adults with migraine and is now completed, with results first posted. The Phase 3 study enrolled approximately 520 participants aged 18 and older across approximately 85 sites worldwide¹, with actual enrollment reaching 545. Its primary outcome was the percentage of participants who discontinued treatment due to treatment-emergent adverse events at Week 24¹.
• A Phase 1 bioavailability study (NCT07680686) of ubrogepant is recruiting. It will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions², enrolling an estimated 52 participants.
• A Phase 1 study of ABBV-313 (NCT07673120) is recruiting. It is designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants³, administered as Injection or Infusion³, with an estimated enrollment of 64.
• A Phase 2b study of AGN-151607-DP (gemibotulinumtoxinA) for upper limb essential tremor (NCT07673107) is recruiting. Participants will receive intramuscular injections of AGN-151607-DP or matching placebo⁴, with a primary outcome of change from baseline in the Essential Tremor Rating Assessment Scale (TETRAS) over 72 weeks⁴, enrolling an estimated 94 participants.
• A separate investigator-led study testing BOTOX for seizure severity (NCT05605756), sponsored by Beth Israel Deaconess Medical Center with AbbVie as collaborator, was terminated due to failure to recruit subjects⁵.