Clinical Trials Arena

Teva reports positive data from Phase III paediatric migraine prevention trial

The trial met its primary endpoint, with AJOVY showing statistically significant superior efficacy versus a placebo.

Teva Pharmaceutical has reported positive data from the Phase III SPACE clinical trial of AJOVY (fremanezumab) in preventing episodic migraines in children and adolescent patients aged six to 17 years.

The multicentre, double-blind, randomised, placebo-controlled, parallel-group trial assessed the safety, efficacy, and tolerability of subcutaneous doses of fremanezumab compared to a placebo over a 12-week period.

A total of 235 children and adolescent patients were part of the trial.

According to the findings, the trial met its primary endpoint, with AJOVY showing statistically significant superior efficacy a versus placebo.

Safety data from the trial was in line with those seen in adult populations, without any new safety concerns reported.

Teva is continuing its research into the impact of AJOVY on paediatric subjects with chronic migraine.

AJOVY is already indicated for the prophylaxis of migraines in adults experiencing at least four migraine days per month and is available in a 225 mg/1.5ml single-dose injection, either in a pre-filled syringe or a pre-filled pen in some countries.

Patients have the option of a 225mg monthly dose or a 675mg quarterly dose, and the medication can be administered by a healthcare professional or self-administered at home without a starting dose.

Teva Pharmaceuticals Global R&D executive vice-president and chief medical officer Eric Hughes said: “The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease.

“The SPACE data supports our ambitions to bring the proven benefits of AJOVY to children and adolescent patients who have fewer treatment options available to them. I am pleased to see that AJOVY is continuing to demonstrate its efficacy and safety in different migraine populations, including paediatric patients.”

In April this year, the company unveiled positive data from a Phase III study evaluating Ajovy for the prevention of migraines in Chinese adult patients.