Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00573443
• Date of registration: 13/12/2007
• Prospective Registration: No
• Primary sponsor: Avanir Pharmaceuticals
• Public title: Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS STAR
• Scientific title: A 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 Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)
• Date of first enrolment: December 2007
• Target sample size: 326
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00573443
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, United States

Contacts

• Name: Adrian Hepner, M.D.
• Affiliation: Avanir Pharmaceuticals

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- 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, or the patient has a diagnosis of multiple sclerosis or probable multiple
sclerosis (according to McDonald criteria, 2001)

- The patient has a clinical history and clinical relevant symptoms of Pseudobulbar
Affect (PBA)

- CNS-LS score at baseline is 13 or greater

Main Exclusion Criteria:

- Patients with myasthenia gravis

- Any personal history of complete heart block, QTc prolongation, or torsades de pointes

- Any family history of congenital QT interval prolongation syndrome

- Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs
(codeine, etc.)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pseudobulbar Affect (PBA)

Intervention(s)

Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg

Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg

Drug: Placebo

Primary Outcome(s)

PBA Episode Rate Ratio (Post/Pre), Regression Adjusted [Time Frame: Baseline to Day 84]

Secondary Outcome(s)

Mean Change From Baseline in CNS-LS Total Score by Visit [Time Frame: Baseline, Day 15, Day 29, Day 57, Day 84]

Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category [Time Frame: Baseline and Day 84]

Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population) [Time Frame: Baseline to Day 84]

Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score [Time Frame: Baseline and Day 84]

Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population) [Time Frame: Baseline to Day 84]

Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects [Time Frame: Baseline, Day 15, Day 29, Day 57, Day 84]

Secondary ID(s)

07-AVR-123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

INC Research

Results

• Results available: Yes
• Date Posted: 10/07/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00573443