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UCB have 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.
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.
Phase IIa study: lacosamide in migraine prophylaxis
The multicentre, randomised, double-blind, placebo-controlled trial was designed to evaluate the efficacy of lacosamide (100 mg/day and 300 mg/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 4-week baseline period. Patients in this trial (218) had a history of episodic migraine with or without aura for at least 1 year and a well-documented three month retrospective history of migraines prior to enrolment. The trial did not meet its primary endpoint. However, a reduction in headache frequency was consistently observed in all treatment groups.
Phase IIa study: rotigotine in fibromyalgia syndrome
The multicentre, randomised, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety of rotigotine (4 mg/24 h and 8 mg/24 h) 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.
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