Clinical Trials 2011: Year in Review
Clinical Trials 2011: Year in Review
ONS has been suggested as a potential treatment option for a variety of intractable primary headache disorders. At least 2 ONS studies have been completed recently, one in the USA and one in the UK (by Boston Scientific Corporation). The US effort (Precision Implantable Stimulator for Migraine) was a phase 3 study that projected to enroll 179 subjects, and the European arm of the study was structured to enroll 25 subjects. The studies reportedly completed data collection in 2009, and results were expected in 2011; the data have yet to be reported. Attempts to obtain an update on the studies from the company were unsuccessful.
The Mayo Clinic conducted a study entitled "Greater occipital nerve block for migraine prophylaxis" and involving local injection of bupivicaine and methylprednisolone. The primary outcome measure: whether patients experienced at least a 50% reduction in the frequency of days with moderate or severe migraine. The study reportedly was completed in mid-2011, but its results have yet to be reported.
DR-105 (Seasonique®, [Teva Women's Health, North Wales, PA, USA]).— Teva Women's Health (formerly Duramed) completed a multicenter, randomized, study that was scheduled to complete in August 2011. This phase 2 study evaluated the frequency and severity of menstrually related migraine headaches before and during the 7-day ethinyl estradiol monotherapy interval in women treated with DR-105 compared with placebo during a 91-day treatment period. DR-105 consists of levonorgestrel 0.15 mg + ethinyl estradiol 0.03 mg. Results are expected at some point in 2012.
A phase 2 study entitled "A randomized, double-blind, placebo-controlled proof of concept study of LY2300559 in patients with migraine" began in early 2011. The primary objective of this study is to measure the change in frequency of migraine attacks per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks. The study is being conducted at 8 sites in the USA. No other information concerning this molecule has been disclosed by the sponsor, Eli Lilly and Company. The study is scheduled to complete in 2012.
NeurAxon planned to develop another multimodal neuronal nitric oxide synthase inhibitor (NXN-462) for the prophylactic treatment of migraine. The phase 2 study was initially expected to begin in 2011, but the company has not provided any recent updates on the development status of the compound. Attempts to contact the company were unsuccessful.
New (and Not So New) Therapies: Migraine Prophylaxis
Occipital Nerve Stimulation (ONS)
ONS has been suggested as a potential treatment option for a variety of intractable primary headache disorders. At least 2 ONS studies have been completed recently, one in the USA and one in the UK (by Boston Scientific Corporation). The US effort (Precision Implantable Stimulator for Migraine) was a phase 3 study that projected to enroll 179 subjects, and the European arm of the study was structured to enroll 25 subjects. The studies reportedly completed data collection in 2009, and results were expected in 2011; the data have yet to be reported. Attempts to obtain an update on the studies from the company were unsuccessful.
Greater Occipital Nerve Block
The Mayo Clinic conducted a study entitled "Greater occipital nerve block for migraine prophylaxis" and involving local injection of bupivicaine and methylprednisolone. The primary outcome measure: whether patients experienced at least a 50% reduction in the frequency of days with moderate or severe migraine. The study reportedly was completed in mid-2011, but its results have yet to be reported.
DR-105 (Seasonique®, [Teva Women's Health, North Wales, PA, USA]).— Teva Women's Health (formerly Duramed) completed a multicenter, randomized, study that was scheduled to complete in August 2011. This phase 2 study evaluated the frequency and severity of menstrually related migraine headaches before and during the 7-day ethinyl estradiol monotherapy interval in women treated with DR-105 compared with placebo during a 91-day treatment period. DR-105 consists of levonorgestrel 0.15 mg + ethinyl estradiol 0.03 mg. Results are expected at some point in 2012.
LY2300559
A phase 2 study entitled "A randomized, double-blind, placebo-controlled proof of concept study of LY2300559 in patients with migraine" began in early 2011. The primary objective of this study is to measure the change in frequency of migraine attacks per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks. The study is being conducted at 8 sites in the USA. No other information concerning this molecule has been disclosed by the sponsor, Eli Lilly and Company. The study is scheduled to complete in 2012.
NXN-462
NeurAxon planned to develop another multimodal neuronal nitric oxide synthase inhibitor (NXN-462) for the prophylactic treatment of migraine. The phase 2 study was initially expected to begin in 2011, but the company has not provided any recent updates on the development status of the compound. Attempts to contact the company were unsuccessful.
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