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Trial record 1 of 1 for:    NCT02534038
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Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition

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ClinicalTrials.gov Identifier: NCT02534038
Recruitment Status : Terminated (The study was terminated prematurely because of difficulty with recruiting.)
First Posted : August 27, 2015
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.

Condition or disease Intervention/treatment Phase
Disinhibition Syndrome Drug: AVP-786 Drug: Placebo Phase 2

Detailed Description:

Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment.

This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods.

Approximately 12 participants will be enrolled at approximately 2 centers in the United States.

Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders
Actual Study Start Date : December 2015
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo drug to be taken twice a day for 6 weeks
Drug: Placebo
matching placebo

Active Comparator: AVP-786
Participants randomized to AVP-786 will take one dose of AVP-786 once a day and one dose of placebo once a day for the first 7 days; from day 8, participants will receive AVP-786 twice a day for 5 weeks.
Drug: AVP-786
d6-DM/Q
Other Name: Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)




Primary Outcome Measures :
  1. Change from Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory [ Time Frame: Baseline, week 6, week 8 and week 14 ]

Secondary Outcome Measures :
  1. Change from Baseline for the Total Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  2. Change from Baseline for the Neuropsychiatric Inventory Total Caregiver Distress [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  3. Change from Baseline for the Neuropsychiatric Inventory Disinhibition Domain Caregiver Distress [ Time Frame: Baseline, week 1, week 3, week 6, week 8, week 9 , week 11 and week 14 ]
  4. Change from Baseline for the Frontal Behavioral Inventory (FBI) Total Score [ Time Frame: Baseline, week 1, week 3, week 6, week 8, week 9 , week 11 and week 14 ]
  5. Change from Baseline for the Frontal Behavioral Inventory (FBI) Disinhibition Domain Score [ Time Frame: Baseline, week 1, week 3, week 6, week 9 , week 11 and week 14 ]
  6. Change from the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale [ Time Frame: week 3, week 6, week 11 and week 14 ]
  7. Change from the First Assessment for the Patient Global Impression of Change (PGIC) Scale [ Time Frame: week 3, week 6, week 11 and week 14 ]
  8. Change from Baseline for the Quality of Relationships (QoR) Scale [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  9. Change from Baseline for the Quality of Life (QoL) Scale [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  10. Change from Baseline for the Interpersonal Reactivity Index (IRI) [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  11. Change from Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS) [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  12. Change from Baseline for the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  13. Change from Baseline for the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: Baseline, week 6, week 8 and week 14 ]
  14. Change from Baseline for the Stroop Color and Word Task [ Time Frame: Baseline, week 6, week 8 and week 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
  • The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
  • The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
  • Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline

Exclusion Criteria:

  • Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
  • Participants with myasthenia gravis
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534038


Locations
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United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Sponsors and Collaborators
Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02534038    
Other Study ID Numbers: 15-AVP-786-203
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Keywords provided by Avanir Pharmaceuticals:
Disinhibition
Additional relevant MeSH terms:
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Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs