Clinical trial NCT00724048 (phase 2/phase 3, status: completed)
Conditions: huntington disease
ICD codes: G10
Drugs: acr16 10 mg, acr16 22.5 mg, acr16 45 mg
SMILES: CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O, CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O, CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written Informed Consent prior to any study related procedure,
             including consent to genotyping of the CYP2D6 gene.

          -  Clinical features of HD, and a positive family history and/or the presence of ≥ 36 CAG
             repeats in the Huntington gene.

          -  Male or female age ≥ 30 years.

          -  Willing and able to take oral medication and to comply with the study specific
             procedures.

          -  Ambulatory, being able to travel to the assessment center, and judged by the
             Investigator as likely to be able to continue to travel for the duration of the study.

          -  Availability of a caregiver or family member to accompany the subject to two visits.

          -  A sum of ≥ 10 points on the mMS at the screening visit.

          -  For subjects taking allowed antidepressants or other psychotropic medication , the
             dosing of medication must have been kept constant for at least 6 weeks before
             enrollment.

        Exclusion Criteria:

          -  Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of
             enrollment, or at any time point during the study period.

          -  Use of tetrabenazine within 12 weeks of enrollment, or at any time during the study
             period.

          -  Treatment with any investigational product within 4 weeks of enrollment.

          -  Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of
             enrollment, or at any time during the study period.

          -  Use of concomitant medication that may lower the seizure threshold within 6 weeks of
             enrollment, or at any time during the study period .

          -  Use of metoclopramide within 12 weeks of enrollment, or at any time during the study
             period.

          -  Subjects currently receiving deep brain stimulation (DBS).

          -  Subjects with a history of surgical procedures aiming to improve the symptoms of
             Huntington disease, such as neural transplantations, lesions of the central nervous
             system, infusions of neurotrophic agents or previous attempts of deep brain
             stimulation.

          -  Subjects previously randomized into this study.

          -  A prolonged QTc interval at Screening Visit (defined as a QTc interval of > 450 msec
             for males or > 470 msec for females), or other clinically significant heart conditions
             as judged by the investigator.

          -  Creatinine clearance <40mL/min as measured at the screening visit.

          -  Any clinically significant, abnormal, baseline laboratory result which in the opinion
             of the Investigator, affects the subjects' suitability for the study or puts the
             subject at risk if he/she enters the study.

          -  Clinically significant hepatic or renal impairment.

          -  Subjects with a known history of epilepsy or a history of febrile seizure(s) or
             seizure(s) of unknown cause.

          -  Severe intercurrent illness, which, in the opinion of the Investigator, may put the
             subject at risk when participating in the trial or may influence the results of the
             trial or affect the subjects' ability to take part in the trial.

          -  Alcohol and/or drug abuse as defined by DSM IV-TR criteria for Substance Abuse - this
             includes the illicit use of cannabis within the last 12 months prior to Screening
             Visit

          -  Subjects with suicidal ideation as defined as a positive score on criteria for major
             depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive Episode

          -  Females who are pregnant or lactating or who intend to become pregnant during the
             study period.

          -  Females who are of child bearing potential and not taking adequate contraceptive
             precautions are excluded from the trial. (Females of child bearing potential taking
             acceptable contraceptive precautions can be included)

          -  Known allergy to any ingredients of the trial medication or placebo

          -  Any previous participation in a clinical study with ACR16.