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| Sponsor: | Phoenix Neurological Associates, LTD |
|---|---|
| Information provided by: | Phoenix Neurological Associates, LTD |
| ClinicalTrials.gov Identifier: | NCT00919555 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: Pioglitazone and Tretinoin Drug: Tretinoin and Pioglitazone HCL Drug: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Tretionoin and Pioglitazone HCL: Active Comparator
20 patients will be randomized blindedly to Tretinoin and Pioglitazone HCL
|
Drug: Pioglitazone and Tretinoin
Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd)
Drug: Tretinoin and Pioglitazone HCL
Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day
|
|
Sugar Pill: Placebo Comparator
10 Patients will randomly receive placebo
|
Drug: Placebo
Placebo
|
Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed with ALS to participate in a double-blind, placebo controlled study of Tretinoin and Pioglitazone HCL, used in combination with Riluzole, for treating ALS. This investigator initiated trial conducted by Dr. Todd Levine and Dr. David Saperstein will help determine whether Tretinoin and Pioglitazone HCL, in combination, can slow the progression of ALS.
At present, there is little to no effective therapy for ALS, nor is there a known cause. Therefore there is a tremendous unmet need for more effective therapy for this disease and that is why the physicians at PNA have been very interested in the role of developing a more active anti-excitotoxic cocktail for patients with ALS. Since recent data have suggested that inflammatory mechanisms may interact with and promote neurodegeneration (where cells in the spinal cord and brain are lost), there have been a number of anti-inflammatory treatment strategies that have been evaluated in animal models. Some studies have shown that mice that were given Pioglitazone HCL demonstrated improved muscle strength and body weight, exhibited a delayed disease onset as well as had a longer survival rate compared to non treated mice.
In addition to these studies, retinoic acids have been studied extensively in various models of the injured nervous system. These studies have shown that retinoic acids, such as Tretinoin may be neuroprotective and support axonal growth, which could in turn slow disease progression.
The purpose of this study is to determine if such a drug "cocktail" could offer the best chance of attaining a significant reduction in disease progression by utilizing currently available FDA-approved agents
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nicole C Hank, MHSM | 602 258-2432 | nhank@pnal.net |
| United States, Arizona | |
| Phoenix Neurological Associates, LTD | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Contact: Nicole C Hank, MHSM 602-258-2432 nhank@pnal.net | |
| Principal Investigator: Todd D Levine, MD | |
| Sub-Investigator: David S Saperstein, MD | |
| Principal Investigator: | Todd D Levine, MD | Phoenix Neurological Associates, LTD |
More Information
| Responsible Party: | Phoenix Neurological Associates, LTD ( Todd Levine, MD ) |
| Study ID Numbers: | 20071808 |
| Study First Received: | June 8, 2009 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00919555 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ALS Treatment Tretinoin Pioglitazone HCL |
Actos Tau levels ALS |
|
Spinal Cord Diseases Pioglitazone Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Pharmacologic Actions |
Keratolytic Agents Hypoglycemic Agents Pathologic Processes Neuromuscular Diseases Amyotrophic Lateral Sclerosis Therapeutic Uses Tretinoin Dermatologic Agents Motor Neuron Disease |
