Minocycline in Patients With Huntington's Disease

NCT00029874 | Completed Phase 1

• 1 other identifier: FD-R-1968-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine whether treatment with minocycline is safe and tolerable in patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in these patients.

Conditions

Huntington's Disease

Keywords

Tetracyclines; Dose-Response Relationship, Drug

Interventions

Minocycline DRUG

Eligibility Criteria

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

You may qualify if:

• Clinical features of Huntington's disease (HD) and a confirmatory family history of HD and/or a CAG repeat expansion of at least 37
• Stage I, II, or III of illness (TFC greater than or equal to 5)
• Ambulatory and not requiring skilled nursing care
• Patients must use effective birth control
• Concurrent psychotropic medications must be at stable dose for at least 4 weeks prior to study
• WBC count at least 3,800/mm3
• Creatinine no greater than 2.0
• Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal

You may not qualify if:

• Prior minocycline use within 2 months of baseline visit
• History of known sensitivity or intolerability to minocycline or any other tetracycline
• History of vestibular disease
• Use of any investigational drug within 30 days of baseline visit
• Treatment with any drug that may cause lupus-like symptoms (e.g., procainamide or hydralazine) within 4 weeks of baseline visit
• Pregnant or nursing
• Underlying hematologic, hepatic, or renal disease
• Evidence of unstable medical illness
• Illness that requires use of coumadin
• Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of baseline visit, or suicidal ideation
• Substance (alcohol or drug) abuse within 1 year of baseline visit
• History of systemic lupus erythematosis (SLE) or a history of SLE in a first-degree relative
• Positive ANA screening (at or above 1:80)

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 24, 2002
• First Posted: January 25, 2002
• Study Start: September 1, 2001
• Study Completion: August 1, 2003
• Last Updated: March 25, 2015

Record last verified: 2004-12

Locations

US (1)