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Glutamate Receptor Antagonist

Memantine for Autism Spectrum Disorder

Phase 3
Recruiting
Led By Gagan Joshi, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male & female subjects ages 8-18 years (inclusive)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

Study Summary

This trial is testing whether the drug memantine can help improve social skills in children and teens with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions.

Who is the study for?
This trial is for boys and girls aged 8-18 with Autism Spectrum Disorder or related conditions, who have at least moderate social impairment. They must not have an IQ below 70, be on certain medications affecting glutamate levels, or have unstable psychiatric conditions. Pregnant/nursing individuals or those with serious illnesses are excluded.Check my eligibility
What is being tested?
The study tests Memantine Hydrochloride (Namenda) over a period of 12 weeks to see if it improves social deficits in youth with Non-Verbal Learning Disorder and High-Functioning Autism Spectrum Disorder. Participants will randomly receive either the drug or a placebo during visits to Massachusetts General Hospital.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common side effects of Memantine may include dizziness, headache, confusion, constipation. Each individual might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Global Impression-Improvement Scale (CGI-I)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MemantineActive Control1 Intervention
Memantine administered in tablet form twice daily titrated to a maximum dose of 20 mg for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in the placebo control group will receive a matched placebo pill with no active ingredients. This will be administered twice daily for 12 weeks.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,401 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,028 Patients Enrolled for Autism Spectrum Disorder
Gagan Joshi, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Kgs Medical College (Medical School)
University Of Pa Hlth System (Residency)
11 Previous Clinical Trials
250 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
237 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the short and long term dangers of Memantine?

"Memantine's safety is based on both efficacy data from Phase 3 trials as well as multiple rounds of supportive safety data, leading our team to rate it a 3."

Answered by AI

Does the age limit for this experiment extend past 60 years old?

"To be eligible for this particular study, applicants must fall in the 8-18 age range. Out of all the medical trials taking place right now, 261 are for people under 18 and 70 are for seniors."

Answered by AI

Are people with the required qualifications able to sign up for this experiment right now?

"That is correct. The information on clinicaltrials.gov affirms that this study, which was first advertised on November 13th 2018, is still looking for 100 participants at a single site."

Answered by AI

What are the preferred demographics for this clinical trial?

"One hundred patients with learning disorders will be enrolled in this clinical trial. In order to qualify, applicants must be aged between 8 and 18 years old."

Answered by AI

Are there other examples in the medical literature of Memantine being studied?

"Presently, there are 26 Memantine clinical trials ongoing with 11 in Phase 3. A few of the Illinois-based trials for Memantine are running out soon, but there are still 290 sites conducting research on Memantine."

Answered by AI

How many patients are participating in this clinical trial?

"That is accurate. The trial, which can be found on clinicaltrials.gov, is currently seeking participants. This study was originally posted on November 13th, 2018 and updated as recently as July 29th, 2022. They are looking for 100 patients from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

wanted to try for my 4 year son to improve his condition.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions
Gagan Joshi 2018. "Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03553875.
All > Asd > Autism
~2 spots leftby Jun 2024
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