Belgium-based biopharmaceutical company UCB has announced top-line results from two proof-of-concept Phase IIa clinical trials to assess the efficacy and safety of lacosamide in migraine prophylaxis, and the efficacy and safety of rotigotine in fibromyalgia syndrome.
According to the company, these trials were designed to determine whether there is justification for further clinical development of lacosamide and rotigotine in these indications. The respective studies did not achieve statistical significance for their primary endpoints. UCB will evaluate development plans once full analyses are available.
The first Phase IIa multicentre, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of lacosamide (100mg/day and 300mg/day) compared to placebo in reducing the frequency of migraine. The primary efficacy variable was the mean reduction of migraine rates during the 14-week maintenance period compared to the average frequency during the four-week baseline period.
Patients in this trial (218) had a history of episodic migraine with or without aura for at least one year and a well-documented three month retrospective history of migraines prior to enrollment. The trial did not meet its primary endpoint. However, a reduction in headache frequency was consistently observed in all treatment groups.
The other Phase IIa multicentre, randomized, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety of rotigotine (4mg/24h and 8mg/24h) compared to placebo in adult patients (240) with signs and symptoms of fibromyalgia syndrome.
The primary efficacy variable was the reduction in pain for patients taking rotigotine as measured by the average Likert pain score at baseline to the last two weeks of the 13 week treatment period. The study results did not achieve statistical significance for its primary endpoint. Only primary efficacy and safety data have been reviewed at this time, the company said.