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Amyotrophic Lateral SclerosisPhase 3NCT00021697

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

A Phase 3 study testing AVP-923 in people with Amyotrophic Lateral Sclerosis, run by Avanir Pharmaceuticals at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
AVP-923
How many people
100 participants
Where
17 sitesUnited States
Study dates
Jan 2001to Apr 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center

    Charlotte, North Carolina, 28203

  • Northwestern Medical School

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Colorado Health Sciences

    Denver, Colorado, 80262

  • Loma Linda University Dept. of Neurology

    Loma Linda, California, 92354

  • UCLA School of Medicine Dept. of Neurology

    Los Angeles, California, 90095

  • University of Wisconsin ALS Clinical Research Center

    Madison, Wisconsin, 53792

  • University of Miami Dept. of Neurology

    Miami, Florida, 33136

  • Columbia-Presbyterian Center Neurological Institute

    New York, New York, 10032

  • MCP-Hahnemann University Dept. of Neurology

    Philadelphia, Pennsylvania, 19107

  • Penn Neurological Institute

    Philadelphia, Pennsylvania, 19107

  • University of Texas Health Science Center @ San Antonio

    San Antonio, Texas, 78229

  • University of California, San Francisco

    San Francisco, California, 94143

  • State University of New York

    Syracuse, New York, 13210

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official 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

The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.

Being tested
AVP-923
Keywords
AVP-923, Dextromethorphan, Quinidine, Pseudobulbar Affect
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVP-923Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2001 (estimated)
  2. Study startJan 2001
  3. Primary completionApr 2002
  4. Study completionApr 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021697
Sponsor's protocol ID
99-AVR-102
Other IDs
AVP-923
Status last verified
Jul 2016
First submitted
1 Aug 2001
Last updated
14 Jul 2016
Results posted
No

Publications

  • Dark FL, McGrath JJ, Ron MA. Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. doi: 10.3109/00048679609065020.

    PubMed 8887697

  • Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995

  • Gallagher JP. Pathologic laughter and crying in ALS: a search for their origin. Acta Neurol Scand. 1989 Aug;80(2):114-7. doi: 10.1111/j.1600-0404.1989.tb03851.x.

    PubMed 2816272

  • Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. doi: 10.1212/wnl.29.10.1435-b. No abstract available.

    PubMed 573397

  • Muller U, Murai T, Bauer-Wittmund T, von Cramon DY. Paroxetine versus citalopram treatment of pathological crying after brain injury. Brain Inj. 1999 Oct;13(10):805-11. doi: 10.1080/026990599121197.

    PubMed 10576464

  • Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997 Jul;63(1):89-93. doi: 10.1136/jnnp.63.1.89.

    PubMed 9221973

  • Schadel M, Wu D, Otton SV, Kalow W, Sellers EM. Pharmacokinetics of dextromethorphan and metabolites in humans: influence of the CYP2D6 phenotype and quinidine inhibition. J Clin Psychopharmacol. 1995 Aug;15(4):263-9. doi: 10.1097/00004714-199508000-00005.

    PubMed 7593709

  • Brooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE. PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS One. 2013 Aug 21;8(8):e72232. doi: 10.1371/journal.pone.0072232. eCollection 2013.

    PubMed 23991068

  • Brooks BR, Thisted RA, Appel SH, Bradley WG, Olney RK, Berg JE, Pope LE, Smith RA; AVP-923 ALS Study Group. Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial. Neurology. 2004 Oct 26;63(8):1364-70. doi: 10.1212/01.wnl.0000142042.50528.2f.

    PubMed 15505150

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AVP-923 in people with Amyotrophic Lateral Sclerosis, run by Avanir Pharmaceuticals at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00021697, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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