Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00021697
• Date of registration: 01/08/2001
• Prospective Registration: No
• Primary sponsor: Avanir Pharmaceuticals
• Public title: Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
• Scientific title: A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis
• Date of first enrolment: January 2001
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00021697
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion:

- 18 to 80 years of age, inclusive

- Confirmed diagnosis of ALS or probable ALS

- Clinical history of pseudobulbar affect

- If female, must not be pregnant, breast-feeding, or planning a pregnancy during the
course of the study, and must have a negative urine pregnancy test prior to start of
study

- If female, must have been practicing an established method of birth control for at
least the prior month (oral contraceptive tablets, hormonal implant device,
intrauterine device, diaphragm and contraceptive cream or foam, condom with
spermicide, tubal ligation, or abstinence) or be surgically sterile or
post-menopausal

- Must be willing to not take any prohibited medications during participation in the
study

Exclusion:

- Known sensitivity to quinidine or opiate drugs (codeine, etc.)

- On any anti-depressive medication

- Recently (within two months) diagnosed with ALS

- Currently participating in, or who within the past 30 days have participated in, the
study of another investigational new drug

- Previously received treatment with co-administration of dextromethorphan and
quinidine

- History of substance abuse within the past two years

- Women who are pregnant or likely to become pregnant during the course of the study



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

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: AVP-923

Secondary ID(s)

99-AVR-102

AVP-923

Source(s) of Monetary Support

Please refer to primary and secondary sponsors