Chelsea (CHTP) Announces Study on Northera Shows Statistical Improvement vs. Placebo
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Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced that Horacio Kaufmann, M.D., Professor of Medicine, NYU Langone Medical Center, New York, will present the full results from the previously reported Northera™ (droxidopa) Study 301 during the oral Clinical Trials Forum at the American Academy of Neurology 64th Annual Meeting in New Orleans, Louisiana, at 12:15 PM ET today. Overall, the results of the study showed droxidopa demonstrated statistical improvement compared to placebo in the trial for the primary clinical endpoint (OHQ composite score), which provides a comprehensive measure of symptoms for neurogenic orthostatic hypotension (known as Neurogenic OH or NOH). The results were consistent irrespective of gender, concomitant medications or primary diagnosis.
Droxidopa is currently under investigation for the treatment of symptomatic Neurogenic OH in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score showed a statistically significant improvement in patients taking droxidopa vs. those taking placebo (-1.83 ± 2.07 vs. -0.93 ± 1.69, respectively, P=0.003). Standing Systolic Blood Pressure (SBP) increased 11.2mmHg with droxidopa vs. 3.9mmHg with placebo (P<0.001). Similar results were observed in Diastolic Blood Pressure (DBP) (increase of 2.1 mmHg).
Most adverse events (AEs) were mild to moderate in severity and were generally considered by investigators to be unlikely or not related to droxidopa. Supine hypertension (SBP >180mmHg) reported as an AE occurred in 2 (2.5%) droxidopa-treated vs. 0 (0%) placebo-treated patients. The most frequent AEs in droxidopa-treated versus placebo-treated patients were headache 7.4% vs. 0%, dizziness 3.7% vs. 1.2%, nausea 2.5% vs. 0%, and falls 0% vs. 3.7%.
Study 301 was a double-blind, multi-center, randomized, placebo-controlled, parallel-group, induction-design study to assess effect on symptoms and their impact on activities of daily living in 263 patients with symptomatic Neurogenic OH. The primary endpoint was the mean change in the OHQ composite score, a patient-reported outcome measure that captures symptoms of Neurogenic OH and their impact on activities of daily living.
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Droxidopa is currently under investigation for the treatment of symptomatic Neurogenic OH in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score showed a statistically significant improvement in patients taking droxidopa vs. those taking placebo (-1.83 ± 2.07 vs. -0.93 ± 1.69, respectively, P=0.003). Standing Systolic Blood Pressure (SBP) increased 11.2mmHg with droxidopa vs. 3.9mmHg with placebo (P<0.001). Similar results were observed in Diastolic Blood Pressure (DBP) (increase of 2.1 mmHg).
Most adverse events (AEs) were mild to moderate in severity and were generally considered by investigators to be unlikely or not related to droxidopa. Supine hypertension (SBP >180mmHg) reported as an AE occurred in 2 (2.5%) droxidopa-treated vs. 0 (0%) placebo-treated patients. The most frequent AEs in droxidopa-treated versus placebo-treated patients were headache 7.4% vs. 0%, dizziness 3.7% vs. 1.2%, nausea 2.5% vs. 0%, and falls 0% vs. 3.7%.
Study 301 was a double-blind, multi-center, randomized, placebo-controlled, parallel-group, induction-design study to assess effect on symptoms and their impact on activities of daily living in 263 patients with symptomatic Neurogenic OH. The primary endpoint was the mean change in the OHQ composite score, a patient-reported outcome measure that captures symptoms of Neurogenic OH and their impact on activities of daily living.
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