Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Autism Speaks | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.
This is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children. This pharmacotherapeutic trial will be conducted as a direct result of findings of a nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from autism. A pharmacological agent, mecamylamine, with specificity for the nicotinic receptors implicated in autism, will be tested in children with autism spectrum disorder. Twenty children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks of either matched placebo (n=8) or mecamylamine (n=12). Children randomized to placebo who do not respond will be given the opportunity to enroll in a ten week open label extension.
The trial has been completed and published in J. of Child & Adolescent Psychopharmacology.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Mecamylamine | Experimental | There will be 12 children in this arm. These children will receive the active medication (mecamylamine). |
|
| Placebo | Placebo Comparator | There will be 8 children in this arm. These children will receive placebo instead of the active medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mecamylamine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| L E Arnold, M.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nisonger Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22537359 | Result | 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. | |
| 37811711 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008464 | Mecamylamine |
| ID | Term |
|---|---|
| D009636 | Norbornanes |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | One pill is taken once daily. |
|
| 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. |
| Expressive Vocabulary test-Second Edition | Baseline and week 14 |
| Adverse Experience checklist and AE log | Baseline, weeks 1, 2, 4, 6, 7, 8, 9, 10, 12, and 14. |
| Cognitive Battery | baseline, weeks 6, 8, and 14 |
| 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |