Minocycline to Treat Amyotrophic Lateral Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00047723
• Date of registration: 16/10/2002
• Prospective Registration: Yes
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Minocycline to Treat Amyotrophic Lateral Sclerosis
• Date of first enrolment: January 2003
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00047723
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Paul H. Gordon, M.D.,
• Affiliation: Associate Medical Director, Eleanor and Lou Gehrig MDA/ALS Center, Columbia University Medical Center

Key inclusion & exclusion criteria

To be eligible for enrollment in this study, subjects must meet the following eligibility
criteria within fourteen days prior to randomization:

Inclusion criteria:

- A clinical diagnosis of laboratory-supported probable, probable or definite ALS,
according to modified EL Escorial criteria.

- FVC greater or equal to 75% of predicted.

- Onset of weakness within 3 years prior to enrollment.

- If patients are receiving riluzole they must be on a stable dose for at least the
past thirty days.

- Women of childbearing age must be non-lactating and surgically sterile or using an
effective method of birth control and have a negative pregnancy test (adequate birth
control includes use of intra-uterine device or oral contraceptives plus a barrier
method, e.g. condom, diaphragm).

- Willing and able to give signed informed consent that has been approved by your
Institutional Review Board (IRB).

Exclusion criteria:

- Requirement for tracheotomy ventilation (or non-invasive ventilation > 23 hours/day).

- Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's
disease, etc).

- FVC < 75% of predicted.

- A clinically significant history of unstable medical illness (unstable angina,
advanced cancer, etc) over the last 30 days.

- History of renal disease (screening creatinine greater than 1.5).

- History of liver disease (screening alanine aminotransferase greater than 3 times the
upper limit of normal).

- History of hematologic disease (screening white blood cell count less than
3,800/mm3).

- History of system lupus erythematosis (or screening ANA of 1:160 or greater).

- Treatment with any medications that may cause lupus-like symptoms within 4 weeks of
baseline visit (e.g. procainamide, hydralazine).

- History of vestibular disease (excluding benign position vertigo).

- Pregnancy or lactation.

- Allergy to tetracycline antibiotics.

- Use of minocycline within thirty days of enrollment (baseline visit).

- Use of anti-epileptic medications other than gabapentin.

- Limited mental capacity rendering the subject unable to provide written informed
consent or comply with evaluation procedures.

- History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.

- Use of any investigational drug within the past 30 days (Creatine, Vioxx, Celebrex,
Topiramate).

- Women with the potential to become pregnant who are not practicing effective birth
control.



Age minimum: 21 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: minocycline

Primary Outcome(s)

Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.

Secondary Outcome(s)

Changes in manual muscle testing (MMT), forced vital capacity (FVC, percent predicted), quality of life (QOL) and survival

Secondary ID(s)

R01NS45294

Source(s) of Monetary Support

Please refer to primary and secondary sponsors