Memantine Therapy in Amyotrophic Lateral Sclerosis
TAME
Phase IIA Open Label Trial of Memantine in Combination With Riluzole (Customary Care) for the Treatment of ALS
1 other identifier
interventional
20
1 country
1
Brief Summary
Tau, a protein in the cerebrospinal fluid CSF is believed to be elevated in amyotrophic lateral sclerosis (ALS) patients. The investigators believe that Tau is truly a marker of increased neuronal death from any disease process. It is been shown that Memantine can inhibit and reverse the abnormal hyperphosphorylation of Tau and therefore the investigators are looking at the efficacy of Memantine at 10 mg twice a day (BID) to see if disease progression correlates with possible changes in Tau in ALS patients based on ALS Functional Rating Scale (ALSFRS) scores.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedNovember 25, 2009
November 1, 2009
4.1 years
November 20, 2009
November 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized assessment of ALS disease progression through the ALS Functional Rating Scale (ALSFRS) and compare the levels of Tau at baseline, 6 and 12 months
18 months
Secondary Outcomes (1)
Change in muscle strength as measured by quantitative dynamometry (baseline vs 18 months)
Study Arms (1)
ACTIVE
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age 18-85
- Male or Female
- Clinically definite ALS by El Escorial criteria
- Elevated levels of Tau in CSF
You may not qualify if:
- Patients with FVC below 1.5 L or who require respiratory assistance
- History of liver disease
- Severe renal failure
- History of intolerance to Riluzole or Memantine
- Any other co morbid condition which would make completion of trial unlikely
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
- Unwillingness to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phoenix Neurological Associates, LTDlead
- Forest Laboratoriescollaborator
Study Sites (1)
Phoenix Neurological Associates, LTD
Phoenix, Arizona, 85018, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 25, 2009
Study Start
June 1, 2005
Primary Completion
July 1, 2009
Study Completion
October 1, 2009
Last Updated
November 25, 2009
Record last verified: 2009-11