Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)
PNA
Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of the study is to determine the safety and the efficacy of Tretinoin and Pioglitazone HCL in patients with ALS who are currently on Riluzole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2008
Typical duration for phase_1
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, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 30, 2012
November 1, 2012
1.4 years
June 8, 2009
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and efficacy of Tretinoin and Pioglitazone HCL in patients with ALS
3 years
Secondary Outcomes (1)
To determine if cerebrospinal fluid tau levels decline over the course of treatment and if the level of tau decline correlates with response in treatment measured by ALSFRS
3 years
Study Arms (2)
Tretionoin and Pioglitazone HCL
ACTIVE COMPARATOR20 patients will be randomized blindedly to Tretinoin and Pioglitazone HCL
Sugar Pill
PLACEBO COMPARATOR10 Patients will randomly receive placebo
Interventions
Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd)
Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day
Eligibility Criteria
You may qualify if:
- El Escorial Classification of laboratory supported probable, probable, or definite ALS
- Age 18 - 85 years
- Male or female
- FVC greater than or equal to 70% predicted
You may not qualify if:
- Patients with FVC below 1.5 L or below 70% predicted
- History of liver disease
- Severe renal failure (CrCl\<30)
- History of coronary artery disease requiring placement of stents, bypass surgery or previous myocardial infarction
- EKG at baseline with evidence for previous myocardial infarction, cardiomyopathy, or arrhythmia
- History of intolerance to Riluzole, Tretinoin, or Pioglitazone HCL
- History of diabetes
- Any other comorbid condition which would make completion of trial unlikely
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phoenix Neurological Associates, LTD
Phoenix, Arizona, 85018, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd D Levine, MD
Phoenix Neurological Associates, LTD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 12, 2009
Study Start
June 1, 2008
Primary Completion
November 1, 2009
Study Completion
March 1, 2012
Last Updated
November 30, 2012
Record last verified: 2012-11