NCT00773812

Brief Summary

The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

5.3 years

First QC Date

October 15, 2008

Last Update Submit

January 11, 2017

Conditions

Autistic DisorderPervasive Developmental Disorder

Keywords

Autistic DisorderAutismMecamylaminePervasive Developmental Disorder-Not Otherwise Specified

Outcome Measures

Primary Outcomes (1)

  • The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual.

    Baseline, weeks 2, 4, 6, 8, 10,12, and 14.

Secondary Outcomes (8)

  • OSU Autism Rating Scale-DSM-IV

    Baseline, week 6, 8, and 14.

  • Repetitive Behavior Questionnaire

    Baseline, week 2, 4, 6, 8, 10, 12, and 14

  • Aberrant Behavior Checklist

    Baseline, week 2, 4, 6, 8, 10, 12, and 14.

  • Ohio Autism Clinical Impressions Scale

    Baseline, weeks 1, 2, 4, 6, 7, 8, 9, 10, 12, and 14.

  • Social Responsiveness Scale

    Baseline, weeks 2, 4, 6, 8, 10, 12, and 14.

  • +3 more secondary outcomes

Study Arms (2)

Active Mecamylamine

EXPERIMENTAL

There will be 12 children in this arm. These children will receive the active medication (mecamylamine).

Drug: mecamylamine

Placebo

PLACEBO COMPARATOR

There will be 8 children in this arm. These children will receive placebo instead of the active medication.

Drug: placebo

Interventions

mecamylamineDRUG

The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.

Also known as: Inversine
Active Mecamylamine
placeboDRUG

One pill is taken once daily.

Placebo

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified
  • Age 4-12
  • General good health
  • IQ of \>=36 or mental age of \>=18 months
  • Parent/caregiver willingness to accompany child to clinic and monitor for side effects

You may not qualify if:

  • Unstable Seizure Disorder
  • Psychoactive medication in the process of adjustment
  • Antipsychotic medication in previous 3 months before baseline
  • Systemic corticoids (inhalers allowed)
  • Planned beginning of major behavioral intervention in 3 months of study or the 2 months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nisonger Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Arnold LE, Aman MG, Hollway J, Hurt E, Bates B, Li X, Farmer C, Anand R, Thompson S, Ramadan Y, Williams C. Placebo-controlled pilot trial of mecamylamine for treatment of autism spectrum disorders. J Child Adolesc Psychopharmacol. 2012 Jun;22(3):198-205. doi: 10.1089/cap.2011.0056. Epub 2012 Apr 26.

    PMID: 22537359RESULT

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

MeSH Terms

Conditions

Autistic DisorderChild Development Disorders, Pervasive

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • L E Arnold, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Director of Nisonger Center

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

July 1, 2007

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(1)