Safety Study of High Doses of Zinc in ALS Patients

NCT01259050 | Completed Phase 1 DMC

• 1 other identifier: Zinc-ALS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety of Zinc given at 90mg/d in conjunction with 2mg/d of copper in ALS patients.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS treatment; Zinc; Copper; BMAA; ALS

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of high doses of zinc in patients with ALS

  1 year

Secondary Outcomes (1)

• Measure levels of BMAA in blood and urine to determine if there is a decline in these levels over the course of treatment

  1 year

Study Arms (1)

Zinc and Copper

EXPERIMENTAL

Drug: Zinc and Copper

Interventions

Zinc and Copper DRUG

Optizinc 90 mg/d Copper 1 mg

Zinc and Copper

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Male or Female
• Clinically definite or probable ALS by El Escorial criteria
• ALS-FRS \> 25
• If on Riluzole they must be on a stable dose for at least 30 days prior to screening
• Capable of providing informed consent and complying with trial procedures

You may not qualify if:

• Patients with FVC below 50%
• History of liver disease
• Severe renal failure
• Creatinine greater than or equal to 1.5 mg/dL
• History of intolerance to zinc or copper
• Evidence of motor neuron disease for greater than 5 years
• Any other co-morbid condition which would make completion of the trial unlikely
• If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
• Patient with history of significant anemia
• Elevated levels of zinc at baseline
• Patients with copper levels below normal at baseline

Sponsors & Collaborators

• Phoenix Neurological Associates, LTD: lead

Study Sites (1)

Phoenix Neurological Associates

Phoenix, Arizona, 85018, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Zinc; Copper

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Todd D Levine, MD

  Phoenix Neurological Associates, LTD

  PRINCIPAL INVESTIGATOR

• David S Saperstein, MD

  Phoenix Neurological Associates, LTD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

US (1)