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RESEARCH: Clinical Trials

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DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY AND TO DETERMINE THE PHARMACOKINETICS OF TWO DOSES OF AVP-923 (DEXTROMETHORPHAN/QUINIDINE) IN THE TREATMENT OF PSEUDOBULBAR AFFECT (PBA) IN PATIENTS WITH ALS.

Design:

Eligible patients will be randomized in a double-blind manner to receive treatment with either one of the two different doses of AVP-923 or AVP-923-20/10 or placebo.
Each patient will be required to complete a diary recording the daily number of laughing and/or crying episodes experienced medication schedule, and any adverse experiences throughout the entire study.
Patients completing Day 85 of the study as scheduled will be eligible to continue in a 12-week open label treatment

Eligibility:

The patient has a diagnosis of Amyotrophic Lateral Sclerosis (according to El Escorial Criteria, WFN, 1998) and the time from diagnosis of ALS is not be longer than 30 months
The patient has a clinical history and clinical relevant symptoms of Pseudobulbar Affect (PBA)
CNS-LS score at baseline is >13
The patient has stable hematologic, hepatic, and renal function, with no clinically significant symptoms, and with clinical laboratory results (CBC, clinical chemistry, and urinalysis) up to 1-fold higher than the upper limit of the value normal range
The patient has a resting respiratory rate between 12 and 20 per minute.
The patient has resting diurnal oxygen saturation ≥ 95% measured with pulse oximeter.
The patient has an ECG (obtained within four weeks prior to entry and evaluated by a certified cardiologist) with no evidence of clinically significant abnormality and with no evidence of: complete heart block, ventricular tachycardia, or frequent unifocal ventricular ectopic beats (>5 per minute).
Patients currently taking selective serotonin reuptake inhibitors for the treatment of major depression for at least 3 months prior to enter into the study are allowed to participate in the study. The SSRI antidepressant dose must remain unchanged during the course of the study. Only 10% of subjects enrolled in the study may be concurrently taking an SSRI, therefore, if this percentage is surpassed, it will be necessary to limit the inclusion of patients taking SSRIs.
Patient must not show current symptoms of a depressive disorder.
Patient must have a score of 19 or lower in the Beck Depression Inventory (BDI-II)
Patient must be willing to not take any prohibited medications during participation in the study

For further information, please contact Kate Dalton: keb2114@columbia.edu and phone number (212) 305-2027.