Trial Outcomes & Findings for Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS (NCT NCT00586573)

Last Updated: 2012-06-07

Results Overview

AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale. Score change from baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

Endpoint, following 12 weeks Memantine Monotherapy

Results posted on

2012-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Memantine 5-20 mg, twice daily, by mouth, 12 weeks
Overall Study STARTED	34
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine n=34 Participants 5-20 mg, twice daily, by mouth, 12 weeks
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	41.8 years STANDARD_DEVIATION 10.8 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	25 Participants n=99 Participants

PRIMARY outcome

Timeframe: Endpoint, following 12 weeks Memantine Monotherapy

Outcome measures

Outcome measures
Measure	Memantine n=34 Participants 5-20 mg, twice daily, by mouth, 12 weeks
DSM-IV ADHD Rating Scale (AISRS) Score Change Total Symptoms	-17.5 Units on a scale Interval -22.3 to -12.6
DSM-IV ADHD Rating Scale (AISRS) Score Change Inattentive Symptoms	-10.6 Units on a scale Interval -13.7 to -7.5
DSM-IV ADHD Rating Scale (AISRS) Score Change Hyperactive Symptoms	-6.9 Units on a scale Interval -9.0 to -4.7

Adverse Events

Memantine

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantine n=34 participants at risk 5-20 mg, twice daily, by mouth, 12 weeks
General disorders Dizzy/Lightheaded	23.5% 8/34 • Number of events 10
Gastrointestinal disorders Gastrointestinal	17.6% 6/34 • Number of events 13
Musculoskeletal and connective tissue disorders Musculoskeletal	17.6% 6/34 • Number of events 13
General disorders Headaches	14.7% 5/34 • Number of events 12
General disorders Sedation	11.8% 4/34 • Number of events 7
General disorders Decreased Energy	8.8% 3/34 • Number of events 4
Psychiatric disorders Anxiety	5.9% 2/34 • Number of events 2
Infections and infestations Cold/infection/allergy	5.9% 2/34 • Number of events 11
Ear and labyrinth disorders Hearing change	2.9% 1/34 • Number of events 1
General disorders Impaired concentration	5.9% 2/34 • Number of events 7
General disorders Insomnia	5.9% 2/34 • Number of events 6
Respiratory, thoracic and mediastinal disorders Asthma	2.9% 1/34 • Number of events 2
Reproductive system and breast disorders Change in sexual function	2.9% 1/34 • Number of events 2
Gastrointestinal disorders Decreased appetite	2.9% 1/34 • Number of events 1
General disorders Increased energy	2.9% 1/34 • Number of events 1
Injury, poisoning and procedural complications Injury	2.9% 1/34 • Number of events 3
General disorders Mucosal dryness	2.9% 1/34 • Number of events 4
Cardiac disorders Palpitation	2.9% 1/34 • Number of events 1
General disorders Tense/jittery	2.9% 1/34 • Number of events 5
Eye disorders Vision/ocular	2.9% 1/34 • Number of events 1

Additional Information

Craig Surman, MD

Massachusetts General Hospital

Phone: 617-503-1424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place