Trial Outcomes & Findings for Namenda (Memantine) for Non-motor Symptoms in Parkinson's Disease (NCT NCT00646204)

Results Overview

Assess the overall change from baseline in ON state motor United Parkinson Disease Rating scale (UPDRS) scores as assessed in the scale. The minimum score is 0 and the maximum score 199. The maximum score of 199 means the worst possible disability from Parkinson's Disease.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2022-12-13

Participant Flow

After baseline assessments, patients (N=40) were randomized to drug and placebo groups. They received a battery of neuropsychiatric assessments. After a safety call (2 weeks after baseline) they returned for identical assessments at week 8.

Participant milestones

Participant milestones
Measure	Memantine-1 Memantine: 10 mg bid	Placebo-2 Matching placebo: bid
Overall Study STARTED	20	20
Overall Study COMPLETED	16	20
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Memantine-1 Memantine: 10 mg bid	Placebo-2 Matching placebo: bid
Overall Study Adverse Event	3	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Namenda (Memantine) for Non-motor Symptoms in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine-1 n=20 Participants Memantine: 10mg bid	Placebo-2 n=20 Participants Matching placebo: bid	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: Tabulations and univariate statistics on difference scores between visits were run using Intercooled Stata V8.0 and included Student's t-test with equal variances and contingency table analysis using Pearson's Chi-square test. Statistics were done using LOCF.

Assess the overall change from baseline in ON state motor United Parkinson Disease Rating scale (UPDRS) scores as assessed in the scale. The minimum score is 0 and the maximum score 199. The maximum score of 199 means the worst possible disability from Parkinson's Disease.

Outcome measures

Outcome measures
Measure	Memantine-1 n=20 Participants Memantine: 10mg bid	Placebo-2 n=20 Participants Matching placebo: bid
Unified Parkinson Disease Rating Scale (UPDRS). Before treatment	12 units on a scale Interval 6.0 to 30.0	12 units on a scale Interval 6.0 to 35.0
Unified Parkinson Disease Rating Scale (UPDRS). After treatment	10 units on a scale Interval 7.0 to 28.0	10 units on a scale Interval 7.0 to 33.0

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Population: Tabulations and univariate statistics on difference scores between visits were run using Intercooled Stata V8.0 for windows (Stata Corporation, College Station, Texas 77845), and included Student's t-test with equal variances and contingency table analysis using Pearson's Chi-square test. Statistics were done using LOCF. Corrections for multiple comparisons were not done.

Change from baseline to end of study in the following assessment: global tremor assessment by examiner. The maximum total score is 48 and would indicate a high prevalence of tremor. The minimum total score is 0 and would indicate no tremor.

Outcome measures

Outcome measures
Measure	Memantine-1 n=20 Participants Memantine: 10mg bid	Placebo-2 n=20 Participants Matching placebo: bid
Analyses Will be Computed for the Categorical Dependent Variable (DV): Global Tremor Assessment by Examiner Baseline	2.8 scores on a scale Standard Deviation 0.54	2.8 scores on a scale Standard Deviation 0.54
Analyses Will be Computed for the Categorical Dependent Variable (DV): Global Tremor Assessment by Examiner 16 Weeks	2.8 scores on a scale Standard Deviation 0.54	2.8 scores on a scale Standard Deviation 0.54

Adverse Events

Experimental: 1-Active Study Drug Memantine 10 mg Big

Serious events: 0 serious events

Other events: 1 other events

Deaths: 3 deaths

Placebo Comparator: 2-placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: 1-Active Study Drug Memantine 10 mg Big n=20 participants at risk Memantine: 10 mg bid	Placebo Comparator: 2-placebo Comparator n=20 participants at risk Matching placebo: bid
Musculoskeletal and connective tissue disorders shoulder pain	5.0% 1/20 • Number of events 1 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.	0.00% 0/20 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.
Nervous system disorders dyskinesia	5.0% 1/20 • Number of events 1 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.	0.00% 0/20 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.
Nervous system disorders lethargy	5.0% 1/20 • Number of events 1 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.	0.00% 0/20 • Consent to end of study (24 weeks) The number of participants at risk for All-Cause Morality is 40, though most Parkinson's Disease patient do not die from Parkinson's Disease, they die from additional symptoms that develop.

Additional Information

William G. Ondo, MD

Baylor College of Medicine/Houston Methodist

Phone: 713-363-8930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60