Minocycline in Patients With Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT00029874
• Date of registration: 24/01/2002
• Prospective Registration: No
• Primary sponsor: FDA Office of Orphan Products Development
• Public title: Minocycline in Patients With Huntington's Disease
• Scientific title: Minocycline Dosing and Safety in Huntington's Disease
• Date of first enrolment: September 2001
• Target sample size: 63
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00029874
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion criteria:

- 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

Exclusion criteria:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Minocycline

Secondary ID(s)

FD-R-1968-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors